Associate Director: Vaccine Process Development
Cambridge, MA 
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Posted 9 days ago
Job Description

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...

We are currently seeking a motivated Associate Director in the Process Development group at Affinivax to support early process development, process qualification, tech transfers to internal and external manufacturing groups, regulatory filing, and drug product commercialization. This role offers opportunity to lead new and existing glycoconjugate vaccine projects based on our proprietary MAPS platform and support continued growth in our process development group by mentoring Research Associates, Scientist and Senior Scientists. We are looking for a strong leader with expertise in process scale-up, technology transfer and commercialization.

You will have the opportunity to...

  • Design, manage, and execute studies relevant to process development of MAPS vaccine drug substances to advance novel vaccine programs from preclinical through clinical stages.
  • Provide technical support to cGMP manufacturing including process improvements, tech transfer, change control, deviation review, process qualification/validation, PPQ protocol review and documentation.
  • Experience supporting Regulatory submissions (IND and BLA), co-author appropriate BLA CMC sections and interacting with Regulatory agencies.
  • Responsible to support and manage novel programs with activities ranging from process optimization, development of in-process analytics, scale-up to commercial scale, tech transfer to CMOs and providing oversight to GMP manufacturing.
  • Provide necessary manufacturing/quality/regulatory input at different stages of development in consultation with the corresponding SME.
  • Provide scientific/technical expertise to develop new biochemical/biophysical methods to support vaccine process development.
  • Interface and collaborate with scientists within our Company's discovery, protein purification, analytical development, quality assurance and quality control teams to solve complex scientific workflows and advance vaccine candidates in development pipeline.
  • Analyze data from process development studies and author reports for internal and external submission, including regulatory agencies such as the FDA.
  • Understand project timelines/deliverables, support and coordinate cross-functional activities to achieve team and company goals.
  • Document, summarize, and present data to senior management.
  • Mentor and provide leadership and support to Scientist's and Research Associate's within the team.

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

  • Ph.D. or an Engineering degree in related fields such as Chemistry/Biochemistry/Biology/Biotechnology/Bioprocessing/Chemical Engineering with at least 6-8 years of experience required.
  • Demonstrated industry experience with process development (Scale-up and tech transfer), process qualification, IND and BLA submissions, GMP manufacturing is preferred.
  • Scientific understanding of current manufacturing technologies, as well as the ability to explore and develop new approaches for overcoming process challenges.
  • Expertise in following disciplines: vaccine process development, glycoconjugate, polysaccharide chemistry, protein purification and characterization, bioconjugation and biorthogonal chemistries, tangential flow filtration (TFF) is preferred.
  • Independent, detail-oriented, and organized with excellent oral and written communication skills.
  • Demonstrated ability to work in a dynamic environment as a team player with a strong work ethic.
  • Familiarity with design of experiments and statistical analysis of data

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.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Associate Degree
Required Experience
6 to 8 years
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