Research Associate, Upstream Process Development

Boston, MA, United States

Research Associate, Upstream Process Development HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year with significant additional economic and social burdens.

We are founded on the legacies of leading vaccine developers that inspire us to have a positive impact on human health and build a company that equalizes opportunity for people around the world by removing barriers of health inequity. Our aim is to have a global impact on human health; we believe the best way to achieve this impact is by developing novel vaccines for severe and life-threatening diseases. HIL-214 is our foundational vaccine candidate from which we are building the company.

Responsibilities:

Serve as subject matter expert on fermentation and/or cell culture unit operations.

Execute process development activities from vial thaw to shake flasks and bioreactors with aseptic operation.

Execute new technology development initiatives to enhance manufacturing capabilities (such as media development, bioreactor fed-batch and perfusion process development, optimization and scale-up).

Support manufacturing investigation supporting activities and program lifecycle management activities.

Implement in-process analytical assays as necessary.

Collaborate with other functions and support upstream team members as necessary.

Collect and control experimental data and maintains accurate daily logs of experiments including methods, results, and conclusions.

Ensure high-quality, timely documentation in electronic laboratory notebooks, technical reports and contribute to regulatory filings.

Education, Experience & Skills: Bachelor or master in cell biology, biochemistry, pharmaceutical sciences or related field.

5+ years (BS) or 3+ years (MS) relevant industrial experience in bioprocessing.

Demonstrated technical expertise in fermentation/cell culture of recombinant proteins.

Upstream processing experienceat small scale, pilot scale and manufacturing scale.

Understanding of analytical methods used to support process development is needed.

Sound knowledge of cGMP practices as applicable to process development, scale up, technology transfer, and manufacturing.

Direct experience with recombinant VLPs or vaccines is highly desirable.

Some experience working with CDMOs is nice to have.

Ability and desire to work in a fast-paced environment.

Demonstrated independent and self-driven research with a strong publication record.

Independently motivated and detail-oriented with good problem-solving ability.

Proficiency in statistical software (JMP, R, etc) for data analysis and tracking and trending.

Demonstrated ability to work efficiently across multiple project teams and business functions.

HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year with significant additional economic and social burdens.

We are founded on the legacies of leading vaccine developers that inspire us to have a positive impact on human health and build a company that equalizes opportunity for people around the world by removing barriers of health inequity. Our aim is to have a global impact on human health; we believe the best way to achieve this impact is by developing novel vaccines for severe and life-threatening diseases. HIL-214 is our foundational vaccine candidate from which we are building the company.

Responsibilities:

Serve as subject matter expert on fermentation and/or cell culture unit operations.

Execute process development activities from vial thaw to shake flasks and bioreactors with aseptic operation.

Execute new technology development initiatives to enhance manufacturing capabilities (such as media development, bioreactor fed-batch and perfusion process development, optimization and scale-up).

Support manufacturing investigation supporting activities and program lifecycle management activities.

Implement in-process analytical assays as necessary.

Collaborate with other functions and support upstream team members as necessary.

Collect and control experimental data and maintains accurate daily logs of experiments including methods, results, and conclusions.

Ensure high-quality, timely documentation in electronic laboratory notebooks, technical reports and contribute to regulatory filings.

Education, Experience & Skills: Bachelor or master in cell biology, biochemistry, pharmaceutical sciences or related field.

5+ years (BS) or 3+ years (MS) relevant industrial experience in bioprocessing.

Demonstrated technical expertise in fermentation/cell culture of recombinant proteins.

Upstream processing experienceat small scale, pilot scale and manufacturing scale.

Understanding of analytical methods used to support process development is needed.

Sound knowledge of cGMP practices as applicable to process development, scale up, technology transfer, and manufacturing.

Direct experience with recombinant VLPs or vaccines is highly desirable.

Some experience working with CDMOs is nice to have.

Ability and desire to work in a fast-paced environment.

Demonstrated independent and self-driven research with a strong publication record.

Independently motivated and detail-oriented with good problem-solving ability.

Proficiency in statistical software (JMP, R, etc) for data analysis and tracking and trending.

Demonstrated ability to work efficiently across multiple project teams and business functions.

Travel, Physical Demands & Work Environment: Seeking Boston local candidates to be on-site 3-4 days per week.

Manual dexterity required to operate office equipment (e.g. computers, phones, etc.).

Typical office and laboratory bending, stooping, and lifting requirements.

Willingness to travel to various meetings or CMO sites, including overnight trips (up to 10%).

HilleVax is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We welcome all to apply.

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