Summary of job description:
The Senior Analyst, Quality Control (QC) Analyst will assist in the setup of the QC laboratories and oversee the testing programs for raw materials used in the production process working in collaboration with cross functional laboratories. The Senior Analyst, QC will be responsible for performing the routine and non-routine QC sampling and testing of raw materials following standard operating procedures (SOPs) and established test methods.
Key responsibilities:
• Assist with set up and stocking of the QC laboratories and sampling areas.
• Manage the raw materials sampling and testing program to ensure materials are released to meet the production schedule.
• Establish and perform internal methods for identity testing of raw materials.
• Coordinate shipment of samples to external testing laboratories and review of testing/data reports.
• Establishes and manages a qualification program for raw materials to confirm to Pharmacopeia requirements
• Perform QC testing of in-process, final product, and raw material samples according to Standard Operating Procedures. Test methods may include but are not limited to; pH, conductivity, osmolality, plaque assay, ELISA's, gel electrophoresis, spectroscopy, and visual appearance.
• Perform water sampling and associated water testing (basic chemical analysis to include USP tests for TOC, pH, conductivity, etc.).
• Represent QC at inter-departmental meetings and interact with external vendors.
• Train other analysts within the department within scope of knowledge.
• Review testing data and records of other QC Analysts, as applicable.
• Write or revise SOPs, protocols and technical reports.
• Participate in QC equipment validation, method transfers and qualifications.
• Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
Other Responsibilities:
• Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies, etc.
• Troubleshoot equipment / analytical testing methods and apply continuous improvement
• Raise change controls and deviations related to QC and assist with non-conformance investigations.
• Assist with internal and regulatory agency audits / inspections.
• Ensure training is kept in GMP compliant state.
Educational Requirements:
• BA or BS in Chemistry/Biochemistry or other related science. Additional industrial experience acceptable as a substitute for degree level educational requirements.
Experience and Skill Requirements:
• Three to five years of laboratory-based experience in a testing capacity, preferably GMP.
• Excellent analytical skills and technical experience is a must, preferentially with previous experience in product and raw materials testing.
• Thorough understanding of industry testing requirements for GMP raw materials.
• Computer literacy (including MS Word and Excel), good communication and organizational skills.
Ability to work independently and with others in a team.
This position is based in our Framingham location and typically has a 5-day on-site expectation.
Salary Range
Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $92,500 - $120,000 The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate's unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.
At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.
