About Affinivax

Affinivax is a Cambridge-based clinical-stage biotechnology company with a novel, next-generation approach to the development of vaccines and immunotherapies targeting infectious and other immune-mediated diseases. This novel and highly efficient vaccine technology - called Multiple Antigen Presenting System (MAPS) - enables the high-affinity binding of protective polysaccharides as well as proteins in a single vaccine, uniquely inducing a broad and protective B-cell and T-cell immune response.

Our vision is to take a major step forward in vaccine innovation to prevent and combat a wide range of infectious and other immune-mediated diseases, protecting infants and adults in our communities and making a meaningful impact on global public health. Affinivax is focused on developing vaccines for the most challenging bacterial infections, with a goal of improving upon existing vaccines and providing solutions for where there are no vaccines or prevention strategies available today.

The role...

Affinivax is currently seeking a highly motivated Senior Analyst I, QC to use his/her expertise to support Quality Control. This position is ideally suited for someone with hands-on experience in quality control testing in a GMP laboratory, OOT/OOS investigations, and preparing protocols/reports.

You will have the opportunity to...

• Testing vaccine intermediates, drug substances, and drug products in a GMP QC laboratory.
• Performing and writing deviation, OOT, OOS investigations, logbook verifications, maintaining and monitoring QC training matrix.
• Trending data, and statistical analysis (JMP).
• Perform analytical testing such as 96-well plate assays, SEC-MALS, HPLC, FTIR, NMR, UV, and biochemical assays.
• Training QC analysts in different assays.
• Peer review of analytical data.
• Maintaining QC lab compliance per Affinivax procedure.
• Additional duties and responsibilities as required.

Who you are and what you bring to the team...

• Master's or bachelor's degree in Chemistry, Biochemistry, or related discipline with 5+ years of relevant hands-on experience in quality control.
• Hands-on experience in performing release and stability testing of biologics/vaccines in a GMP QC is a must.
• Experience in writing deviations, OOS/OOT investigations, change controls, CAPA, protocols, and reports.
• Experience in working in a GMP QC laboratory and performing biochemical tests and HPLC analysis. Experience in SEC-MALS is a plus.
• Candidate should know about GDP, Data Integrity, FDA and EU Guidance, ICH Guidance, USP Monographs, and General Chapters.
• Experience with LIMS and documentation systems such as TrackWise.
• Experience in statistical analysis using software such as JMP is a plus.
• Strong ability to multi-task and willingness to work effectively in a highly collaborative and diverse environment as a team player.
• Ability and desire to work in a fast-paced environment.

What We Offer:

• Competitive compensation
• Medical and Dental plans (BCBS), employer-paid at 85%
• Vision Insurance, employer-paid at 100%
• Life Insurance, Short- and Long-Term Disability
• Flexible Spending Accounts/Health Savings Accounts
• Wellness Benefits
• 401(k) Plan with a 4% match
• Tuition Reimbursement
• Generous PTO package
• 11 paid holidays, plus Holiday Shutdown
• Pet Insurance
• Subsidized Parking
• Commuter Reimbursement Program
• Brand new facility in Kendall Square

Please Note:
In accordance with Affinivax's duty to provide and maintain a safe workplace that is free of known hazards, we have adopted a COVID-19 vaccine policy to protect the health of our employees and their families, our visitors, and the community at large from COVID-19. This policy requires all employees, contractors, and temporary workers, to (1) obtain an approved vaccination and provide proof of vaccination or (2) request an accommodation for a medical or religious exemption. Our policy is based on guidance from the Centers for Disease Control (CDC) and Prevention.

Affinivax is committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, genetic information, status as a veteran or as a member of the military or status in any group protected by applicable federal or state laws.

Agencies:
All resumes submitted by search firms/employment agencies to any employee at Affinivax via email, the internet, or in any form and/or method will be deemed the sole property of Affinivax, unless such search firms/employment agencies were engaged by Affinivax for this position and a valid agreement with Affinivax is in place. In the event a candidate who was submitted outside of the Affinivax agency engagement process is hired, no fee or payment of any kind will be paid.