Senior Scientist/Senior Engineer, Vaccine Process Development

Company: Affinivax Inc.
Location: Cambridge
Posted on: May 13, 2022

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 an exceptional Senior Scientist/Senior Process Engineer in the Downstream Process Development group at Affinivax. We are looking for a strong leader with expertise in process scale-up, technology transfer, and commercialization. We are looking for a team player with problem-solving skills who exhibits a passion for leading and mentoring and has subject matter expertise in the Process Development of glycoconjugate vaccines. This role offers an opportunity to lead new and existing vaccine projects based on our proprietary MAPS platform and support continued growth in our vaccine development group.

You will have the opportunity to---
Design, manage and execute studies relevant to the process development of MAPS vaccine drug substances to advance novel vaccine programs from preclinical through clinical stages.
Provide technical support for cGMP manufacturing including process improvements, change control, deviation review, PPQ protocol review, and documentation.
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.
Identify equipment necessary to meet program scale-up and commercial manufacturing needs and develop processes at 1L to 250L scale.
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 the 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 Scientists and Associate Scientists 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 5-8 years of experience required.
Demonstrated industry experience with process development, assay development, scale-up, GMP manufacturing, and tech transfer is preferred.
Scientific understanding of current manufacturing technologies, as well as the ability to explore and develop new approaches for overcoming scale-up challenges.
Design 3D CAD models and collaborate with vendors to produce prototypes and production parts. Perform engineering analyses and relevant physical testing on designs.
Expertise in protein bioconjugation using covalent and non-covalent interactions and biorthogonal chemistries is preferred.
Polysaccharide chemistry, characterization, and purification are a plus.
Experience in protein purification and chromatography experience will be considered.
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 experimental design and statistical analysis of data
Able to maintain written records in the form of laboratory notebooks.

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.

Keywords: Affinivax Inc., Cambridge , Senior Scientist/Senior Engineer, Vaccine Process Development, Engineering , Cambridge, Massachusetts