Associate Director, Drug Product Process Development

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 has an exciting new opportunity in our Formulation Development team. We are looking for a highly motivated scientist and engineer to work with our experienced, energetic, and passionate team to develop a novel formulation and drug product process development to support our exciting MAPS technology.

You will have the opportunity to…

• Contribute to pre-formulation and formulation development for our multi-valent vaccines.
• Help design and implement scalable strategies for drug product fill/finish for clinical and commercial programs.
• Perform process development experiments using scientifically sound technology including design-of-experiments approaches.
• Evaluate critical process parameters including mixing, settling rate, and shearing forces for suspension formulations.
• Generate, interpret, and present data packages to cross-functional teams.
• Generate development and technical reports and contribute to regulatory filings.
• Provide technical leadership to CMO and manufacturing including but not limited to formulation or process improvements, and troubleshooting.
• Perform comprehensive and critical evaluation of own data and data from associate scientists.
• Work closely with Analytical Development and Process Development teams.

Who you are and what you bring to the team…

• BS in Pharmaceutical Sciences, Chemistry, and Chemical Engineering or equivalent with 10-20 years of relevant industrial experience
• Ph.D. in Pharmaceutical Science, Chemistry, or Chemical Engineering equivalent with 7-10 years of experience or MS with 10-15 years of experience
• Desire to learn and work in vaccine drug product process development
• Ability and desire to work in a fast-paced environment
• Strong collaboration, team player, and work ethics
• Strong written and oral communication skills

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.

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