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…

Produce pharmaceutical components and products by following current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) within a cleanroom environment. Responsibilities include, but are not limited to, the operation and performance of equipment used in the manufacturing unit processes. Perform the weighing of manufacturing ingredients and the manufacturing of the intermediate formulations. Tasks include documentation, data entry, and computer software with compliant systems. Participation in continuous safety and environmental inspections. Maintain continuous inventory control using a computerized system. Must be willing and able to work in rotating shifts, extended periods, and/or overtime when required.

You will have the opportunity to…

• Follow aseptic procedures and good documentation practices.
• Follow production schedule and prepare materials for production runs.
• Prepare solutions per production schedule.
• Cleaning, operating and maintaining GMP equipment.
• Prepare equipment for processing by performing cleaning-in-place (CIP) and cleaning-out-of-place (COP), as necessary.
• Perform equipment inspections to ensure readiness and preventative maintenance, as needed.
• Operate and monitor GMP equipment, adjust equipment controls, perform actions as specified by production batch records (BPRs), adhere to aseptic behaviors, and maintain a safe and clean work environment by following cGMPs.
• Document production by completing forms, reports, logs, and records of equipment batches.
• Maintain up-to-date training records.
• Perform cleaning of production suites daily and as necessary.
• Create and edit production records and documents, as necessary.
• Work with environmental monitoring to maintain a clean and safe work environment.
• Ability to lift up to 20lbs.
• Additional duties and responsibilities as required.

Who you are and what you bring to the team…

• Associates degree in an area of life sciences with a minimum of 1 year of experience in manufacturing production or a Bachelor’s degree in an area of life sciences with < 1 year of experience in manufacturing production required
• Effective oral and written communication skills
• Experience or understanding of pharmaceutical development preferred
• Knowledge of cGMP, GDP, USP, and FDA quality guidelines and regulations preferred
• Process organizational skills to ensure production batch completeness preferred

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.