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Facilities/Stability Coordinator (GMP)

Reports To:             Facilities Manager

Department:             Administration (Facilities)

 

Job Summary: 

Facilities/Stability Coordinator will work closely with the Facilities Manager to coordinate and prioritize and perform day to day workflow. The most important responsibility is to inform Quality Control and Quality Assurance Departments about any issues with the stability chambers.

Essential Duties/Responsibilities:

  1. Proven ability to monitor and maintain BMS, preferably with Siemens Desigo (currently upgrading from Apogee Insight), writing and maintaining proper documentation.
  2. Will ensure that all monitored points are perpetually in an acceptable state of validation and calibration.
  3. Will be responsible for ensuring all points identified on the BMS are maintained using in-house resources and/or outside vendors, routine inspections, alarms responded to with proper notifications and documented following SOP’s and Good Documentation Practices.
  4. Performs equipment maintenance on lyophilizers, stability chambers, liquid fillers, labeling equipment, packaging equipment, water system equipment and filtration and other equipment.
  5. Writing/documenting in chambers’ logbooks.
  6. Performs qualifications.
  7. Developing appropriate SOPs.
  8. Review weekly forms.
    • Humidity, differential pressure, temperature, etc.

Other Duties and Responsibilities as Requested:

  • Maintain a preventive maintenance program on equipment.
  • Schedule, coordinate and oversee in-house service requests for routine building upkeep and minor repairs.
  • Perform in-house PM tasks or routine inspections on various HVAC, mechanical, utility systems and lab equipment (GMP and non-GMP).
  • Will be responsible for ensuring all PM Program tasks are completed and documented properly according to policies, procedures, and Good Documentation Practices (GDP) following and adhering to relevant SOPs (Standard Operating Procedures).
  • Participation in some non-routine weekend or off-hours work dependent on the site’s demands, as well as afterhours alarm support.
  • Schedule, coordinate and oversee service requests for upkeep and repairs of stability chamber, incubator, refrigerator, freezer and oven.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

Physical Requirements:

  • Walking: to move through facility.
  • Seeing: to monitor facility and find equipment for cleaning, to work at computer and read instructions.
  • Sitting: to work at a computer.
  • Talking / Hearing: to communicate with staff and clients.
  • Reaching: to clean equipment and building.
  • Stooping: to clean equipment and building.
  • Pulling: to move furniture/equipment and to sweep floor.
  • Pushing: to move furniture/equipment; to sweep and vacuum; to use cleaning cart.
  • Lifting: to move furniture/equipment, up to 50 pounds.
  • Climbing: to use ladder to reach equipment with 3 points of contact; to climb stairs when needed

Skills:

  • Strong knowledge of Microsoft Office software preferred.
  • Knowledge of Qualio, Auto CAD, Remote Desktop, & Siemens Desigo (currently upgrading from Apogee Insight) is a plus.
  • Must have the ability to multi-task, coordinate workload by priority, and take and follow direction.
  • Responsible for accurately documenting all activity and providing excellent customer service to inhouse customers and vendors.
  • Excellent organization and communication skills.
  • Must be customer service and quality driven.
  • Must comply with all applicable rules and regulations of a Pharmaceutical industry, including FDA regulations such as cGMP, EH&S regulations, and company regulations such as the employee handbook.
  • Must possess a basic knowledge of EHS and Cal/OSHA practices.

Competencies:

  • Responsibility/Ownership—the individual takes ownership of their assigned system or process and is constantly trying to improve it.
  • Problem Solving—the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully – including researching the internet.
  • Interpersonal Skills—the individual maintains confidentiality, remains open to others’ ideas and exhibits willingness to try new things. Respects co-workers.
  • Oral Communication—the individual speaks clearly and persuasively in positive or negative situations.
  • Written Communication—the individual edits work for spelling and grammar, presents numerical data effectively and can read and interpret written information.
  • Planning/Organizing—the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
  • Quality Control—the individual demonstrates accuracy and thoroughness and monitors own work to ensure quality.
  • Quality Assurance—the individual demonstrates competency by following all related SOP’s and immediately disclosing any discrepancies.
  • Adaptability—the individual adapts to changes in the work environment, manages competing demands and can deal with frequent change, delays or unexpected events.
  • Dependability—the individual is consistently at work and on time, follows instructions, responds to management direction and solicits feedback to improve performance.
  • Enthusiasm—the individual actively promotes and personally projects a positive attitude and a willingness to learn and go the extra mile when appropriate.

Experience:

Minimum of 5+ years of general facility experience required.

Experience and knowledge of Critical Utilities and Pharmaceutical / Biotech processing equipment and environments.

Prior cGMP experience is strongly preferred.

Education:

High school graduate or higher, plus trade school training specific, to one or more of listed essential function above.

Job Type: Full-time.

IRISYS, LLC is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. IRISYS does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

To Apply: If you are interested in being part of the IRISYS LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference “Facilities/Stability Coordinator (GMP)” in the subject line of the email.

Note: Stay Safe From Recruitment Fraud! At IRISYS, LLC we do not ask for your personal or financial details or ask to send any money for transfers or payments from applicants to secure a job as an employee. All positions are on-site.

Director of Manufacturing

Reports To:             Senior Vice President, Corporate Development

Department:             Manufacturing

 

IRISYS serves as the development, manufacturing, regulatory and strategic partner for innovative pharma companies, and the National Institutes of Health as they move compounds from early research through the clinical trials required for regulatory approvals. IRISYS also manufactures, under contract prescription and OTC pharmaceuticals.

Job Summary:

The Director of Manufacturing is responsible for driving quality, efficiency, and leading the expansion of our company’s pharmaceutical formulations manufacturing department. The successful candidate will have a strong record of accomplishments and successful leadership experience in drug development, clinical trial material manufacturing, Quality Assurance, and commercial drug product manufacturing, preferably with experience in a pharma company that has scaled from early-stage pre-formulation studies to qualification, validation and commercial production. Experience with sterile product manufacturing in addition to oral solids and liquids is a plus.

Essential Duties/Responsibilities:

  1. Coordinating with all departments and leading the Manufacturing Department to complete scale -up, validation, launch and routine manufacturing of oral dosage forms and sterile products.
  • Product and process validation protocol development, execution, and reporting.
  • Cleaning validation protocol development, execution, and reporting.
  • New equipment IQ/OQ/PQ (protocol development, execution, reporting).
  • Master batch records (creation and revision).
  1. Oversight of the creation and maintenance of production schedules with the assistance of the Manufacturing Supervisor(s) and concurrence of the management group.
  • Scheduling and Supervision of Manufacturing Supervisors.
  • Oversight of Manufacturing Supervisors in the final review of batch documentation.
  • In cooperation with Manufacturing Supervisor(s) and Manufacturing Associates, ensures proper maintenance of all manufacturing equipment.
  • Training of Manufacturing Supervisors and Manufacturing Associates.
  • Oversight of inventory control to the extent that the Director of Manufacturing will be responsible for the receiving process for raw materials and will interact with the Manufacturing Supervisors, Purchasing Group, Controller, and QC/QA to ensure that materials are available as needed.
  • Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
  1. Demonstrates commitment to the development, implementation, and effectiveness of Quality Management System per cGMP company wide in close cooperation with QA. Takes responsibility for:
  • General training
  • SOP writing
  • Equipment maintenance and calibration
  1. Responsible for quoting and establishing feasibility for new business opportunities including new product cost analysis. Participate with Senior management in the development of new business Contract Manufacturing.
  2. Assume responsibility for the validation, maintenance, and operation of sterile filling and lyophilization line.
  3. Contributes new ideas for internal product development.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

Competencies:

  • Responsibility/Ownership – the individual takes ownership of their assigned system or process and is constantly trying to improve it.
  • Problem solving—the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully – including researching the internet.
  • Interpersonal Skills—the individual maintains confidentiality, remains open to others’ ideas and exhibits willingness to try new things. Respects co-workers.
  • Oral communication—the individual speaks clearly and persuasively in positive or negative situations.
  • Written Communication—the individual edits work for spelling and grammar, presents numerical data effectively and can read and interpret written information.
  • Planning/organizing—the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
  • Quality control—the individual demonstrates accuracy and thoroughness and monitors own work to ensure quality.
  • Quality assurance—the individual demonstrates competency by following all related SOP’s and immediately disclosing any discrepancies.
  • Adaptability—the individual adapts to changes in the work environment, manages competing demands and can deal with frequent change, delays or unexpected events.
  • Dependability—the individual is consistently at work and on time, follows instructions, responds to management direction and solicits feedback to improve performance.
  • Enthusiasm—the individual actively promotes and personally projects a positive attitude and a willingness to learn and go the extra mile when appropriate.

Experience/Skills:

10+ years leading a GMP manufacturing environment (Staff development, production planning, compliance, mfg. process cost improvement, safety, and cost control).

3+ years of project management experience is desired.

7+ years of supervisory experience; coaching, mentoring, and training staff at all levels.

Working experience with capacity modeling, process mapping, Lean/Six Sigma, and value stream mapping.

Experience in working with manufacturing-based technology, processes and knowledge of Environmental Health and Safety practices is preferred.

Excellent communication skills, both written and verbal.

Education:

Bachelor’s degree required in Engineering (Mechanical, Chemical or Manufacturing), Chemistry, Biochemistry, or related scientific field. Advanced degree preferred. Experience in lieu of higher degree will be considered.

Job Type: Full-time

IRISYS, LLC is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. IRISYS does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

To Apply: If you are interested in being part of the IRISYS LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference “Director of Manufacturing” in the subject line of the email.

Note: Stay Safe From Recruitment Fraud! At IRISYS, LLC we do not ask for your personal or financial details or ask to send any money for transfers or payments from applicants to secure a job as an employee. All positions are on-site.

Manufacturing Supervisor (Capsules, Oral Dosage Forms)

Reports To:             Manager – Manufacturing / Technical Services

Department:             Manufacturing

 

Job Summary:

The Manufacturing Supervisor performs tasks related to cGMP procedures, including but not limited to review and execution of SOP’s, batch records, validations, cleaning, and maintenance of machinery and manufacturing areas.

Essential Duties/Responsibilities:

  1. Supervise manufacturing associates in the production of GMP goods in a controlled manufacturing area.
  2. Perform coaching and/or corrective action as required.
  3. Executing and review batch record in real time during the process according to cGMP procedures.
  4. Revise and continuously improve batch records as record, most importantly, addressing Deviations and process improvements.
  5. Work Closely with all support groups such as Quality Assurance, Quality Control and Facilities.
  6. Maintaining a safe and clean working environment.
  7. Identifying safety hazards and developing corrective actions to mitigate safety issues.
  8. Coordinate with Manufacturing Associates to communicate with Quality Departments on scheduling of sample submissions on work to be performed.
  9. Understand the installing and setting up equipment. Training newer Associates to setup equipment.  Provide assistance to Validation and have Associates train on the functionality.
  10. Identifying tools and products we may need and driving to transport them whenever needed.

The above reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all the specific requirements of this position. These job duties/responsibilities may change or vary in response to business needs.

Skills:

  • Able to read and understand Standard Operating Procedures.
  • Supervisory experience and performance management of subordinates.
  • Ability to document deviations, Out Of Specifications, Out of Tolerance, and review Batch Records in real time.
  • Proficient in Microsoft Office products such as Word, Excel, Outlook, and PowerPoint.

Physical Requirements:

  • Reaching: to clean equipment and building.
  • Stooping: to clean equipment and building.
  • Pulling: to move furniture/equipment and to sweep floor.
  • Pushing: to move furniture/equipment; to sweep and vacuum; to use cleaning cart.
  • Lifting: to move furniture/equipment, up to 50 pounds.

Competencies:

  • Responsibility/Ownership – the individual takes ownership of their assigned system or process and is constantly trying to improve it.
  • Problem solving—the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully – including researching the internet.
  • Interpersonal Skills—the individual maintains confidentiality, remains open to others’ ideas and exhibits willingness to try new things. Respects co-workers.
  • Oral communication—the individual speaks clearly and persuasively in positive or negative situations.
  • Written Communication—the individual edits work for spelling and grammar, presents numerical data effectively and can read and interpret written information.
  • Planning/organizing—the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
  • Quality control—the individual demonstrates accuracy and thoroughness and monitors own work to ensure quality.
  • Quality assurance—the individual demonstrates competency by following all related SOP’s and immediately disclosing any discrepancies.
  • Adaptability—the individual adapts to changes in the work environment, manages competing demands and can deal with frequent change, delays or unexpected events.
  • Dependability—the individual is consistently at work and on time, follows instructions, responds to management direction and solicits feedback to improve performance.
  • Enthusiasm—the individual actively promotes and personally projects a positive attitude and a willingness to learn and go the extra mile when appropriate.

Experience:

A minimum of 3 years in capsule manufacturing in a GMP environment.

Mechanical experience in set up of an automated capsule fill machine.

Identifying safety hazards and instituting 6S Lean Methodologies is a plus.

Education:

A minimum of an Associate’s Degree. A Bachelor’s degree is preferred. Industry experience will be considered in lieu of education.

Job Type: Full-Time.

IRISYS, LLC is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. IRISYS does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

To Apply: If you are interested in being part of the IRISYS LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference “Manufacturing Supervisor” in the subject line of the email.

Note: Stay Safe From Recruitment Fraud! At IRISYS, LLC we do not ask for your personal or financial details or ask to send any money for transfers or payments from applicants to secure a job as an employee. All positions are on-site.

Manufacturing Associate

Reports To:             Manufacturing Lead / Manufacturing Supervisor

Department:             Manufacturing

 

Job Summary:

The Manufacturing Associate performs tasks related to cGMP procedures, including but not limited to review and execution of SOP’s, batch records, validations, cleaning, and maintenance of machinery and manufacturing areas.  This individual will be experienced in manufacturing in a GMP environment.

Essential Duties/Responsibilities:

  1. Manufacturing associates in the production of GMP goods in a controlled manufacturing area.
  2. Executing and review batch record in real time during the process according to cGMP procedures.
  3. Work Closely with all support groups such as Quality Assurance, Quality Control and Facilities.
  4. Maintaining a safe and clean working environment.
  5. Identifying safety hazards and developing corrective actions to mitigate safety issues.
  6. Coordinate with Manufacturing Management to communicate with Quality Departments on scheduling of sample submissions on work to be performed.
  7. Understand the installing and setting up equipment. Training newer Associates to setup equipment.  Provide assistance to Validation and have Associates train on the functionality.
  8. Identifying tools and products we may need and driving to transport them whenever needed.

The above reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all the specific requirements of this position. These job duties/responsibilities may change or vary in response to business needs.

Skills:

  • Able to read, understand Standard Operating Procedures.
  • Willingness to learn new tasks and projects is a plus.
  • Ability to document deviations, Out Of Specifications, Out of Tolerance, and review Batch Records in real time.
  • Microsoft Office products such as Word, Excel, Outlook, and PowerPoint.

Physical Requirements:

  • Reaching: to clean equipment and building.
  • Stooping: to clean equipment and building.
  • Pulling: to move furniture/equipment and to sweep floor.
  • Pushing: to move furniture/equipment; to sweep and vacuum; to use cleaning cart.
  • Lifting: to move furniture/equipment, up to 50 pounds.

Competencies:

  • Responsibility/Ownership – the individual takes ownership of their assigned system or process and is constantly trying to improve it.
  • Problem solving—the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully – including researching the internet.
  • Interpersonal Skills—the individual maintains confidentiality, remains open to others’ ideas and exhibits willingness to try new things. Respects co-workers.
  • Oral communication—the individual speaks clearly and persuasively in positive or negative situations.
  • Written Communication—the individual edits work for spelling and grammar, presents numerical data effectively and can read and interpret written information.
  • Planning/organizing—the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
  • Quality control—the individual demonstrates accuracy and thoroughness and monitors own work to ensure quality.
  • Quality assurance—the individual demonstrates competency by following all related SOP’s and immediately disclosing any discrepancies.
  • Adaptability—the individual adapts to changes in the work environment, manages competing demands and can deal with frequent change, delays or unexpected events.
  • Dependability—the individual is consistently at work and on time, follows instructions, responds to management direction and solicits feedback to improve performance.
  • Enthusiasm—the individual actively promotes and personally projects a positive attitude and a willingness to learn and go the extra mile when appropriate.

Experience:

A proven demonstration of leading in a GMP manufacturing environment.

Mechanical experience in set up of automated and semiautomated equipment.

Identifying safety hazards and instituting 6S Lean Methodologies is a plus.

Education:

An Associate’s Degree is preferred. Industry experience will be considered in lieu of education.

Job Type: Full-Time.

IRISYS, LLC is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. IRISYS does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

To Apply: If you are interested in being part of the IRISYS LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference “Manufacturing Associate” in the subject line of the email.

Note: Stay Safe From Recruitment Fraud! At IRISYS, LLC we do not ask for your personal or financial details or ask to send any money for transfers or payments from applicants to secure a job as an employee. All positions are on-site.

Manufacturing/Technical Service Manager

Reports To:             Senior Vice President, Corporate Development

Department:             Manufacturing

 

Job Summary:

As the Manufacturing/Technical Services Manager, you will manage, coordinate, and perform activities related to commercial drug product preparation, as well as product development and technology transfer from Development to manufacturing. This includes all aspects of the control of commercial production as well as small scale production of prototypes in cooperation with the Pharmaceutical Development and Manufacturing group, process and cleaning validation, process changes to support existing products, and optimization of existing products/processes. You will also be asked to participate/lead the estimation of the cost of production of new products. As new capabilities are added, you will be expected to participate in design qualification, installation qualification, operational qualification, performance qualification and validation of new equipment.

The Manufacturing/Technical Services Manager will also be expected to interact with Quality Assurance Department to mediate any deficiencies in the IRISYS Quality Assurance System.

Essential Duties/Responsibilities:

  1. Scheduling and Supervision of Manufacturing Supervisors/Associates.
  2. Oversight of Manufacturing Supervisors in the final review of batch documentation.
  3. In cooperation with Manufacturing Supervisor(s) and Manufacturing Associates, ensures proper maintenance of all manufacturing equipment.
  4. Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
  5. Participate with the development group in product development. May have primary responsibility for certain product development projects.
  6. Manufacturing technology transfers to validation and manufacturing groups, process improvement.
  7. Transfer the technical knowledge of the process (by working with project scientist) to manufacturing.
  8. Monitor progress of technical projects, communicate status, and resolve issues that may arise.
  9. Maintain and expand knowledge of current and new manufacturing technologies., advance process technologies.
  10. Write/review/approve change controls and master GMP documents for manufacturing/packaging; equipment installation/operational qualifications, process validation documentation, standard operating procedures, annual quality reviews, departmental reports (technology transfers, process validation, cleaning validation, investigation, process optimization/improvement, CAPAs/investigations, master batch records).
  11. Ensure staff is adequately trained to perform job assignments. May identify and develop specific training content to support ongoing development efforts, supervise and/or mentor junior level engineers.
  12. Collaborate with other functional groups within the site to achieve project goals and meet timelines.
  13. Ensure ongoing adherence to all company policies/procedures, compliance/regulatory mandates and quality requirements.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

Competencies:

  • Responsibility/Ownership – the individual takes ownership of their assigned system or process and is constantly trying to improve it.
  • Problem solving—the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully – including researching the internet.
  • Interpersonal Skills—the individual maintains confidentiality, remains open to others’ ideas and exhibits willingness to try new things. Respects co-workers.
  • Oral communication—the individual speaks clearly and persuasively in positive or negative situations.
  • Written Communication—the individual edits work for spelling and grammar, presents numerical data effectively and can read and interpret written information.
  • Planning/organizing—the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
  • Quality control—the individual demonstrates accuracy and thoroughness and monitors own work to ensure quality.
  • Quality assurance—the individual demonstrates competency by following all related SOP’s and immediately disclosing any discrepancies.
  • Adaptability—the individual adapts to changes in the work environment, manages competing demands and can deal with frequent change, delays or unexpected events.
  • Dependability—the individual is consistently at work and on time, follows instructions, responds to management direction and solicits feedback to improve performance.
  • Enthusiasm—the individual actively promotes and personally projects a positive attitude and a willingness to learn and go the extra mile when appropriate.

Experience/Skills:

10+ years leading a GMP manufacturing environment (Staff development, production planning, compliance, mfg. process cost improvement, safety, and cost control).

3+ years of project management experience is desired.

7+ years of supervisory experience; coaching, mentoring, and training staff at all levels.

Working experience with capacity modeling, process mapping, Lean/Six Sigma, and value stream mapping.

Experience in working with manufacturing-based technology, processes and knowledge of Environmental Health and Safety practices is preferred.

Excellent communication skills, both written and verbal.

Education:

Bachelor’s degree required in Engineering (Mechanical, Chemical or Manufacturing), Chemistry, Biochemistry, or related scientific field. Advanced degree preferred. Experience in lieu of higher degree will be considered.

Job Type: Full-time

IRISYS, LLC is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. IRISYS does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

To Apply: If you are interested in being part of the IRISYS LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference “Manufacturing/Technical Services Manager” in the subject line of the email.

Note: Stay Safe From Recruitment Fraud! At IRISYS, LLC we do not ask for your personal or financial details or ask to send any money for transfers or payments from applicants to secure a job as an employee. All positions are on-site.

Validation and Manufacturing Specialist

Reports To:             Manufacturing, Quality & Validation Manager

Department:             Manufacturing

 

Job Summary:

Validation/Manufacturing Specialists perform tasks related to cGMP procedures, including but not limited to review and execution of SOP’s, batch records, qualifications, process validations, cleaning validations, and maintenance of machinery and manufacturing areas.

Essential Duties/Responsibilities:

  1. Develop and review projects through the entire validation lifecycle (URS, FAT, SAT, DQ, IQ, OQ, PQ).
  2. Executing protocols and batch records according to cGxP procedures.
  3. Maintain a clean working environment while identifying safety hazards.
  4. Coordinate and collaborate with different departments regarding scheduling of sample submissions and work to be performed.
  5. Install, set up and clean manufacturing equipment according to cGxP.

The above reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all the specific requirements of this position. These job duties/responsibilities may change or vary in response to business needs.

Skills:

Qualifications, cleaning and process validations.

Experience working in GMP environment.

Advanced computer and verbal communication skills.

Competencies:

  • Responsibility/Ownership – the individual takes ownership of their assigned system or process and is constantly trying to improve it.
  • Problem solving—the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully – including researching the internet.
  • Interpersonal Skills—the individual maintains confidentiality, remains open to others’ ideas and exhibits willingness to try new things. Respects co-workers.
  • Oral communication—the individual speaks clearly and persuasively in positive or negative situations.
  • Written Communication—the individual edits work for spelling and grammar, presents numerical data effectively and can read and interpret written information.
  • Planning/organizing—the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
  • Quality control—the individual demonstrates accuracy and thoroughness and monitors own work to ensure quality.
  • Quality assurance—the individual demonstrates competency by following all related SOP’s and immediately disclosing any discrepancies.
  • Adaptability—the individual adapts to changes in the work environment, manages competing demands and can deal with frequent change, delays or unexpected events.
  • Dependability—the individual is consistently at work and on time, follows instructions, responds to management direction and solicits feedback to improve performance.
  • Enthusiasm—the individual actively promotes and personally projects a positive attitude and a willingness to learn and go the extra mile when appropriate.

Experience:

2 years in qualifications (DQ/IQ/OQ/PQ), cleaning and process validations

Education:

Bachelor’s Degree in Science.

Job Type: Full-time.

IRISYS, LLC is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. IRISYS does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

To Apply: If you are interested in being part of the IRISYS LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference “Validation and Manufacturing Specialist” in the subject line of the email.

Note: Stay Safe From Recruitment Fraud! At IRISYS, LLC we do not ask for your personal or financial details or ask to send any money for transfers or payments from applicants to secure a job as an employee. All positions are on-site.

PDM Scientist

Reports To:             Senior Scientists/PDM Group Leaders

Department:           Pharmaceutical Development and Manufacturing (PDM)

 

Job Summary:

This position supplies support to development and manufacturing activities within IRISYS.

Essential Duties/Responsibilities:

  1. Design, definition, development, and evaluation of dosage forms for parenteral and oral administration and pre-formulation studies to evaluate drug suitability for controlled release dosing or drug targeting, determining solubility and stability of drug substances.
  2. Conduct feasibility assessment of new analytical methods using a wide variety of instrument technology such as HPLC, LC/MS/MS, Malvern Zeta sizer, etc.
  3. Writing of technical reports, protocols, and summaries.
  4. Support manufacturing activities by creation of batch records, performance of manufacturing activities, equipment qualifications and creation of SOPs. These tasks are done in compliance with IRISYS’ SOPs and policies.
  5. The Scientist is expected to perform independently and/or under minimal supervision.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

Competencies:

  • Responsibility/Ownership – the individual takes ownership of their assigned system or process and is constantly trying to improve it.
  • Problem solving—the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully – including researching the internet.
  • Interpersonal Skills—the individual maintains confidentiality, remains open to others’ ideas and exhibits willingness to try new things. Respects co-workers.
  • Oral communication—the individual speaks clearly and persuasively in positive or negative situations.
  • Written Communication—the individual edits work for spelling and grammar, presents numerical data effectively and can read and interpret written information.
  • Planning/organizing—the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
  • Quality control—the individual demonstrates accuracy and thoroughness and monitors own work to ensure quality.
  • Quality assurance—the individual demonstrates competency by following all related SOP’s and immediately disclosing any discrepancies.
  • Adaptability—the individual adapts to changes in the work environment, manages competing demands and can deal with frequent change, delays or unexpected events.
  • Dependability—the individual is consistently at work and on time, follows instructions, responds to management direction and solicits feedback to improve performance.
  • Enthusiasm—the individual actively promotes and personally projects a positive attitude and a willingness to learn and go the extra mile when appropriate.

Experience/Skills:

Advanced computer and verbal communication skills.

Experience working in GMP environment.

Hands-on experience in the preparation and analysis of small molecule and/or protein formulations and stability studies.

Experience with formulation ingredient regulations for cosmetic and food industries is a plus.

Education:

Bachelor’s degree required in Chemistry, Biochemistry, Pharmaceutical Science, Formulation Science, Chemical Engineering with 5 years of experience; MS with 2 years of experience or Ph. D. preferred.

Job Type: Full-time

IRISYS, LLC is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. IRISYS does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

To Apply: If you are interested in being part of the IRISYS LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference “PDM Scientist” in the subject line of the email.

Note: Stay Safe From Recruitment Fraud! At IRISYS, LLC we do not ask for your personal or financial details or ask to send any money for transfers or payments from applicants to secure a job as an employee. All positions are on-site.

PDM Associate

Reports To:             Scientists/Group Leaders

Department:             Pharmaceutical Development and Manufacturing (PDM)

 

Job Summary:

PDM Associate will work under general direction, assisting the research investigators by performing moderately complex research and experimentation following established protocols.

Essential Duties/Responsibilities:

  1. Perform cGMP manufacturing of Sterile and Non-sterile dosage forms.
  2. Responsible for ordering GMP and PDM supplies for manufacturing campaigns and GLP studies.
  3. Work with Quality departments (QC and QA) to maintain Manufacturing project goals and timelines.
  4. Responsible for set-up of Production suites as per IRISYS LLC
  5. Perform various editorial duties; writes, reviews and edits SOP’s, Batch records and Material specifications.
  6. Create and Execute Qualification Protocols for new equipment at IRISYS
  7. Sets-up and operates various scientific apparatus, such as centrifuges, mixers, lyophilizers, incubators, homogenizers, tablet press, capsule filling machine.
  8. Perform and analyze data generated by analytical methods such as HPLC and Particle Size analyzer.
  9. Assist Scientists/Group Leaders with research projects.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

Knowledge, Skills and/or Abilities:

Familiarity with cGMP/FDA regulations.

Knowledge of laboratory procedures, of the use and preparation of solution, chemicals, and reagents.

Verbal and written communication skills.

Ability to follow oral and written instructions, to tend to details, to maintain records and inventory.

Competencies:

  • Responsibility/Ownership – the individual takes ownership of their assigned system or process and is constantly trying to improve it.
  • Problem solving—the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully – including researching the internet.
  • Interpersonal Skills—the individual maintains confidentiality, remains open to others’ ideas and exhibits willingness to try new things. Respects co-workers.
  • Oral communication—the individual speaks clearly and persuasively in positive or negative situations.
  • Written Communication—the individual edits work for spelling and grammar, presents numerical data effectively and can read and interpret written information.
  • Planning/organizing—the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
  • Quality control—the individual demonstrates accuracy and thoroughness and monitors own work to ensure quality.
  • Quality assurance—the individual demonstrates competency by following all related SOP’s and immediately disclosing any discrepancies.
  • Adaptability—the individual adapts to changes in the work environment, manages competing demands and can deal with frequent change, delays or unexpected events.
  • Dependability—the individual is consistently at work and on time, follows instructions, responds to management direction and solicits feedback to improve performance.
  • Enthusiasm—the individual actively promotes and personally projects a positive attitude and a willingness to learn and go the extra mile when appropriate.

Experience:

2+ years in the Pharmaceutical or Health science sector.

Experience with cGMP manufacturing is highly preferred.

Experience with or some knowledge of pharmaceutical Research, Development and Manufacturing unit processes (e.g., powder granulations, powder blending, tablet compression, encapsulation, aseptic mix and fill procedures, microencapsulation, etc.) is desirable.

Education:

A qualified candidate for the position must have at a minimum bachelor’s degree in Chemistry, Biochemistry, Physical Chemistry or other related field.

Job Type: Full-time

IRISYS, LLC is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. IRISYS does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

To Apply: If you are interested in being part of the IRISYS LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference “PDM Associate” in the subject line of the email.

Note: Stay Safe From Recruitment Fraud! At IRISYS, LLC we do not ask for your personal or financial details or ask to send any money for transfers or payments from applicants to secure a job as an employee. All positions are on-site.

Stability Coordinator

Reports To:             Executive Director QA & Regulatory Affairs

Department:             Quality Assurance

 

Job Summary: 

The Stability Coordinator will be responsible for performing multiple tasks within the Quality Control Department as manager of the stability program. This position is expected to coordinate the tracking of stability protocols and stability samples placed in the stability chambers, and ensure stability pulls and testing for each stability timepoint are performed in a timely manner per the stability schedule and the Company’s Standard Operating Procedures. The Stability Coordinator will work in tandem with the Facilities Coordinator to decide appropriate measures to take when responding to stability chamber alarms, handling data excursions, and coordinating repairs when necessary.

Essential Duties/Responsibilities:

  1. Maintaining the stability schedule.
  2. Tracking stability samples that are placed inside and removed from the stability chambers.
  3. Tracking stability protocols.
  4. Writing stability protocols and reports.
  5. Evaluating stability chamber alarms and handling excursions.
  6. Tracking the validation and calibration of stability chambers.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

Skills:

Self-starter with excellent organization skills.

Excellent writing skills (knowledge of proper spelling and grammar is a must).

Competencies:

  • Responsibility/Ownership – the individual takes ownership of their assigned system or process and is constantly trying to improve it.
  • Problem solving—the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully – including researching the internet.
  • Interpersonal Skills—the individual maintains confidentiality, remains open to others’ ideas and exhibits willingness to try new things. Respects co-workers.
  • Oral communication—the individual speaks clearly and persuasively in positive or negative situations.
  • Written Communication—the individual edits work for spelling and grammar, presents numerical data effectively and can read and interpret written information.
  • Planning/organizing—the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
  • Quality control—the individual demonstrates accuracy and thoroughness and monitors own work to ensure quality.
  • Quality assurance—the individual demonstrates competency by following all related SOP’s and immediately disclosing any discrepancies.
  • Adaptability—the individual adapts to changes in the work environment, manages competing demands and can deal with frequent change, delays or unexpected events.
  • Dependability—the individual is consistently at work and on time, follows instructions, responds to management direction and solicits feedback to improve performance.
  • Enthusiasm—the individual actively promotes and personally projects a positive attitude and a willingness to learn and go the extra mile when appropriate.

Experience:

1-3 years’ experience working in a GMP environment, Quality Control laboratory or completed college science and laboratory coursework credits or equivalent.

Education:

Bachelor’s degree in Science or related field.

Job Type: Full-time

IRISYS, LLC is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. IRISYS does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

To Apply: If you are interested in being part of the IRISYS LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference “Stability Coordinator” in the subject line of the email.

Note: Stay Safe From Recruitment Fraud! At IRISYS, LLC we do not ask for your personal or financial details or ask to send any money for transfers or payments from applicants to secure a job as an employee. All positions are on-site.

QA Specialist

Reports To:             QA Senior Manager

Department:             Quality Assurance

 

Job Summary:

The QA Specialist is responsible for Master Batch Record (MBR) and Executed Batch Record Review (EBR).

Essential Duties/Responsibilities:

  1. Document Control:
    • Processing of change controls for new and revised documents using IriSys’ document management system.
  2. Assignment of Tracking Numbers:
    • Responsible for completion of Quality Assurance logbooks for the assignment of numbers for deviations, CAPAs, batch records, test methods, equipment, product lot numbers, etc.
  3. Support for Client and Regulatory Audits:
    • Provide on-going support for client and regulatory audits.
  4. Support for Calibration and Preventive Maintenance of Equipment:
    • Responsible for review of calibration certificates for compliance with SOP requirements and equipment specifications.
  5. Internal Audits:
    • At the request of QA management, perform internal audits of IRISYS quality systems and records for GMP laboratories, manufacturing, facilities and shipping/receiving.
  6. QA Main Support:
    • Provide QA support for manufacturing operations including: performance of line clearances, Quality Assurance governance / inspection of manufacturing operations in the GMP manufacturing suites, review of master and executed batch records, ensure compliance with IRISYS documentation requirements, ensure production deviations and CAPASs are initiated and closed out.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

Competencies:

  • Responsibility/Ownership – the individual takes ownership of their assigned system or process and is constantly trying to improve it.
  • Problem solving—the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully – including researching the internet.
  • Interpersonal Skills—the individual maintains confidentiality, remains open to others’ ideas and exhibits willingness to try new things. Respects co-workers.
  • Oral communication—the individual speaks clearly and persuasively in positive or negative situations.
  • Written Communication—the individual edits work for spelling and grammar, presents numerical data effectively and can read and interpret written information.
  • Planning/organizing—the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
  • Quality control—the individual demonstrates accuracy and thoroughness and monitors own work to ensure quality.
  • Quality assurance—the individual demonstrates competency by following all related SOP’s and immediately disclosing any discrepancies.
  • Adaptability—the individual adapts to changes in the work environment, manages competing demands and can deal with frequent change, delays or unexpected events.
  • Dependability—the individual is consistently at work and on time, follows instructions, responds to management direction and solicits feedback to improve performance.
  • Enthusiasm—the individual actively promotes and personally projects a positive attitude and a willingness to learn and go the extra mile when appropriate.

Experience:

3-5 years of Quality Control or analytical/bioanalytical chemistry experience in a GMP laboratory in the pharmaceutical industry.

Must have experience in Batch Record reviewing.

Education:

College Degree required in Chemistry, Biochemistry, Biology, or related Science.

Job Type: Full-time

IRISYS, LLC is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. IRISYS does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

To Apply: If you are interested in being part of the IRISYS LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference “QA Specialist” in the subject line of the email.

Note: Stay Safe From Recruitment Fraud! At IRISYS, LLC we do not ask for your personal or financial details or ask to send any money for transfers or payments from applicants to secure a job as an employee. All positions are on-site.