Senior Scientist, Technology Transfer

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.

Objectives / Overview:

Technology Transfer Senior Scientist position within Bioprocess Development team will be responsible for:

• Lead technical transfer of early and late clinical phase drug substance/drug product, to both internal and external contract development & manufacturing (CDMO) companies.

• Provide strong scientific leadership and subject matter expertise for all aspects of drug substance/drug product including technology transfer, process fit analysis, process modelling, raw material controls and aseptic process assurance/microbiological control.

• Lead timely risk identification, communication and resolution and work in close collaboration with analytical development (AD), manufacturing science and technology (MSAT), quality control (QC), quality assurance (QA), regulatory affairs (RA), and internal/external manufacturing sites.

Responsibilities:

Lead process design, development and scale up of VLP production process:

• Technical support for ongoing clinical manufacturing, process troubleshooting to manufacturing activities such as supporting process related investigations, deviation resolution, corrective actions/preventative actions, and direct responsibility for process monitoring/control charting of manufacturing operations.

• Review of technical documents and support for regulatory submissions (IND/IMPD, BLA/MAA) are other responsibilities.

• Manage and lead clinical technical transfer process and ensure alignment with CMC schedule to meet program and company goals / metrics, as required.

• Provide technical assessment to enable selection of drug substance/drug product Contract Development and Manufacturing Organizations (CDMO).

• Perform facility fit analysis, process gap assessments, and establish operational control strategy for each new receiving site.

• Review batch records, process validation protocols, change controls, and deviations to support GMP manufacturing throughout lifecycle of biologics pipeline in partnering with QA and Alexion operations as applicable.

• Ensure appropriate data management, perform process monitoring and communicate operation status to management.

• Identify issues and risks and lead cross functional team to identify and drive alignment on action/mitigation plan for path forward.

• Lead continuous improvement of efficiency of technology transfer plans and work process and influence manufacturing sites to focus on improving efficiency of technology transfer processes.

Education, Experience & Skills:

• Masters or PhD in Chemical Engineering, Pharmaceutical sciences or equivalent. Ph.D is preferred.

• A minimum of 5 years' experience (Ph.D) or MS with a minimum of 8 years' experience in scale up and tech transfer of GMP operations is required.

• Direct experience with recombinant VLPs or vaccines is highly desirable.

• Developed leadership skills and the ability to communicate business objectives as well as technical information effectively.

• Proven experience in managing and coordinating both internal and external deliverables.

• Demonstrated technical expertise in recombinant protein expression and purification.

• Knowledge of quality attribute measurement assays and application to troubleshooting product quality related discrepancies.

• Sound knowledge of cGMP practices as applicable to process development, scale up, technology transfer, formulation development and Manufacturing

• 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 manufacturing sites, including overnight trips (up to 20%).

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.