Job Posts
We are currently looking for:
Aseptic Clinical Production Technician
IRISYS LLC has an open temporary position for an Aseptic Clinical Production Technician. Candidate should have working experience in aseptic production of injectables and other sterile pharmaceutical products.
Primary Responsibilities:
- Verifies that correct components are used.
- Follows all established procedures and policies.
- Performs necessary quality checks relative to the operation.
- Inspects components, materials, and product to ensure any required equipment/material is present with proper identification, acceptable quality, and correct quantity.
- Ensures manufacturing equipment has necessary supplies and materials for the operation.
- Report quality deviations to lead person/supervisor and assists with resulting investigations.
- Assist with Scientists in implementation of corrective and/or preventive actions.
- Ensure facility and equipment is maintained in a clean and organized fashion.
- Assist in set up of manufacturing suites and line clearances per standard operating procedures.
- Review and/or complete production documentation (i.e. Master Batch Records, Specifications) in a timely fashion and with a high degree of accuracy in accordance with company policies/procedures and cGMPs/GDPs.
- Maintains work area in a neat and orderly condition.
- Performs minor troubleshooting and/or works with Facilities to resolve machine stoppages and quality issues.
- Ability to read, interpret, and apply company policies, procedures, and cGMPs relative to job function.
Knowledge, Skills and/or Abilities:
- Experience with working in Aseptic Suites in a cGMP environment
- Familiarity with cGMP/FDA regulations
- Experience with production of bulk solutions up for sterile products, sterile filtration, and aseptic fill operations.
- Proficient in Microsoft Office
- Good Communication Skills
Required Experience:
Bachelor’s or higher degree in chemistry, biochemistry, physical chemistry, or another related field is preferred.
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.
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 “Aseptic Clinical Production Technician ” in the subject line of the email.
Aseptic Clinical Production Supervisor
IRISYS LLC has an open temporary position for an Aseptic Clinical Production Supervisor. Candidate should have working experience in aseptic production of injectables and other sterile pharmaceutical products.
Primary Responsibilities:
- Verifies that correct components are used.
- Follows all established procedures and policies.
- Performs necessary quality checks relative to the operation.
- Inspects components, materials, and product to ensure any required equipment/material is present with proper identification, acceptable quality, and correct quantity.
- Ensures manufacturing equipment has necessary supplies and materials for the operation.
- Report quality deviations to lead person/supervisor and assists with resulting investigations.
- Assist with Scientists in implementation of corrective and/or preventive actions.
- Ensure facility and equipment is maintained in a clean and organized fashion.
- Assist in set up of manufacturing suites and line clearances per standard operating procedures.
- Review and/or complete production documentation (i.e. Master Batch Records, Specifications) in a timely fashion and with a high degree of accuracy in accordance with company policies/procedures and cGMPs/GDPs.
- Maintains work area in a neat and orderly condition.
- Performs minor troubleshooting and/or works with Facilities to resolve machine stoppages and quality issues.
- Ability to read, interpret, and apply company policies, procedures, and cGMPs relative to job function.
Knowledge, Skills and/or Abilities:
- Experience with working in Aseptic Suites in a cGMP environment
- Familiarity with cGMP/FDA regulations
- Experience with production of bulk solutions up for sterile products, sterile filtration, and aseptic fill operations.
- Proficient in Microsoft Office
- Good Communication Skills
Required Experience:
Bachelor’s or higher degree in chemistry, biochemistry, physical chemistry, or another related field is required. Experience in lieu of higher degree combined with a bachelors will be considered.
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.
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 “Aseptic Clinical Production Supervisor” in the subject line of the email.
Technical Service Manger
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.
Director, Manufacturing
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
- 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)
- 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
- 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.
QA Specialist
Position Summary:
The QA Specialist is responsible for document control functions, issuance of controlled documents, updating of SOP binders, maintenance of training records and sending of training notices, assignment of tracking numbers, support for client and regulatory audits, documentation support for client and regulatory audits, and performance of internal audits.
Essential Duties/Responsibilities:
- Document Control –
- Processing of change controls for new and revised documents using IriSys’ document management system. Ensure that document reviewers are properly assigned, and review timelines are met, edits to documents are performed properly and revisions histories accurately represent the changes made.
- Ensure that controlled document binders, if used, are updated with new/revised SOPs and outdated controlled documents are removed from binders. Responsible for ensuring that the SOP table of contents is always current.
- Training –
- Following approval of the document, the QA specialist is responsible for ensuring that training notices are sent to employees and that than training is completed.
- Responsible for ensuring that hard-copy training records are filed according to IriSys procedures in employee training files and for ensuring that training files remain in a state of audit-readiness.
- Maintain the schedule for annual GMP training, coordinating of training dates with staff members, and ensuring that attendance sheets are completed by each person in attendance. Responsible for archiving a copy of the GMP training presentation with training documentation.
- Coordination of safety training of staff members for sessions involving environmental health and safety, fire extinguisher training, evaluation training, etc.
- 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.
- Support for Client and Regulatory Audits
- Responsible for providing support including locating, inspection, and delivery of requested document to the audit room.
- Notifying staff members when their presence is requested by the client or regulatory agency during audits.
- Coordination with internal staff members to make necessary corrections to document that are identified during the audit.
- Perform the functions of note taker/scribe during audits if requested by QA management.
- Support for Calibration and Preventive Maintenance of Equipment
- Responsible for review of calibration certificates for compliance with SOP requirements and equipment specifications.
- Notification of QA management and the department equipment owner of all “as-found” calibration failures. Assignment of investigation numbers and management of the tracking system for completion.
- 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
Education:
- College Degree required in chemistry, biochemistry, biology, or related science
Experience/Skills:
- 3-5 years of Qualty Control or analytical/bioanalytical chemistry experience in a GMP laboratory in the pharmaceutical industry.
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 “QA Specialist” in the subject line of the email.