• Technical Service Manager
• Director, Manufacturing
• Research Associate
• Facilities Coordinator

Position Summary: 

As a Technical Service Manager, you will manage, coordinate, and perform activities related to product development and technology transfer from Research & Development to manufacturing.  This includes small scale production of prototypes in cooperation with the R&D group, process and cleaning validation,  process changes to support existing product development, and optimization of existing products/processes.

Essential Duties/Responsibilities:

• Participate with the development group in product development. May have primary responsibility for certain product development
• Manufacturing technology transfers to validation and manufacturing groups, process improvement.
• Transfer the technical knowledge of the process (by working with project scientist) to manufacturing.
• Monitor progress of technical projects, communicate status, and resolve issues that may arise.
• Maintain and expand knowledge of current and new manufacturing technologies. Advance process technologies.
• 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).
• 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.
• Collaborate with other functional groups within the site to achieve project goals and meet the timelines.
• Ensure ongoing adherence to all company policies/procedures, compliance/regulatory mandates and quality requirements

Education:

• Bachelor’s degree or advanced degree in Science, Engineering, or Pharmaceutics. Bachelor’s degree required; Master’s degree preferred

Experience/Skills:

• Minimum of three years professional work experience in R&D or Technical service/Application Development role
• Knowledge of pharmaceutical GMPs and regulatory requirements (FDA, DEA, OSHA).
• Possess project management and facilitation skills and technical competence.
•  Possess applied knowledge of root cause analysis and troubleshooting techniques. Able to apply statistical analyses and experimental design techniques
• Competent in English (both written and verbal). Strong technical writing skills with attention to detail and verbal/written communication skills. Able to generate high quality technical documentation (Protocols, Reports, MBRs, etc.).
•  Proficiency with MS Office. Knowledge of data management systems (Master Control, SAP, etc.)

IRISYS, LLC is an Equal Opportunity employer – M/F/Veteran/Disability – committed to the hiring, advancement, and fair treatment of all individuals. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other protected status as designated by 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 “Technical Service Manager” in the subject line of the email.

Position Summary: 

IRISYS LLC is seeking to a Director of Manufacturing to join our team. IRISYS serves as the Research & Development, manufacturing, regulatory and strategic partner for innovative pharma companies, and the National Institute 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.

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, and commercial drug product manufacturing, preferably with experience in a pharma company that has scaled from early-stage pre-formulation studies to qualification and validation. Experience with sterile product manufacturing in addition to oral solids is a plus.

Essential Duties/Responsibilities:

• Coordinating with all departments and leading department to complete scale -up, validation, launch and routine manufacturing of oral dosage forms and sterile products
  1. Product and process validation protocol development, execution, and reporting
  2. Cleaning validation protocol development, execution, and reporting
  3. New equipment IQ/OQ/PQ (protocol development, execution, reporting)
• Oversight of the creation and maintenance of production schedules with the assistance of the Manufacturing Supervisor(s) and concurrence of the management group.
  1. Scheduling and Supervision of Manufacturing Supervisors
  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. Training of Manufacturing Supervisors and Manufacturing Associates
  5. 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
  6. Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines
• Demonstrates commitment to the development, implementation, and effectiveness of Quality Management System per cGMP
• Responsible for quoting and establishing feasibility for new business opportunities including new product cost analysis

Education:

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

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.

IRISYS, LLC is an Equal Opportunity employer – M/F/Veteran/Disability – committed to the hiring, advancement, and fair treatment of all individuals. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other protected status as designated by 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, Manufacturing” in the subject line of the email.

Job Summary:

Research 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 R&D 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 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.

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.

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.

 

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 “Research Associate” in the subject line of the email.

Job Summary: 

Facilities Coordinator will work closely with the Facilities Manager to coordinate and prioritize and perform day to day workflow.

 

Essential Duties/Responsibilities:

1. Performs equipment maintenance on lyophilizes, liquid fillers, labeling equipment, packaging equipment, water system equipment and filtration and other equipment.
2. Inspect, diagnose, and repair mechanical defects/failures on various electrical and mechanical systems.
3. Prioritize equipment repair and maintenance work.
4. Maintain a preventive maintenance program on equipment.
5. Schedule, coordinate and oversee inhouse service requests for routine building upkeep and minor repairs.
6. Schedule, coordinate and oversee outside service providers for routine CM and PM Program tasks provided under building, system or equipment maintenance contacts.
7. Perform in-house PM tasks or routine inspections on various HVAC, mechanical, utility systems and lab equipment (GMP and non-GMP).
8. 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).
9. Assist in the performance, schedule, coordinate and oversee emergency troubleshooting and repair on various HVAC, mechanical, utility systems and lab equipment (GMP and non-GMP).
10. Provide technical and hands-on support to other departments and general office requests, such as movement of equipment or furniture.
11. Candidate must have knowledge and understanding of industrial and pharmaceutical safety practices.
12. Participation in some non-routine weekend or off-hours work dependent on the site’s demands, as well as afterhours alarm support.

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.

Skills:

• Strong knowledge of Microsoft Office software preferred.
• Knowledge of Qualio, Auto CAD, Remote Desktop, & Siemens Apogee Insight 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.
• Lift up to 50 pounds.

Education:

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

Job Type: Full-time, temporary for 6 months (with benefits and possible permanent position)

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 Coordinator” in the subject line of the email.