Senior Scientist/Senior Engineer, Vaccine Process Development
Company: Affinivax Inc.
Posted on: May 13, 2022
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.
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
Provide necessary manufacturing/quality/regulatory input at
different stages of development in consultation with the
Provide scientific/technical expertise to develop new
biochemical/biophysical methods to support vaccine process
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
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
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
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
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
Able to maintain written records in the form of laboratory
What We Offer
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
401(k) Plan with a 4% match
Generous PTO package
11 paid holidays, plus Holiday Shutdown
Commuter Reimbursement Program
Brand new facility in Kendall Square
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
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