(USP) Senior Process Engineer, Drug Substance Manufacturing HilleVax is a biopharmaceutical company focused on the development and commercialization of novel vaccines. Our initial program, HIL-214, is a virus-like particle-based vaccine candidate in development for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection.
We initiated a Phase 2b study, NEST-IN1 to evaluate the safety, immunogenicity, and efficacy of HIL-214 in infants. In addition to infants, we also plan to seek approval of HIL-214 in additional age groups such as older children, adults, and older adults. We expect to report top-line data.
HilleVax has assembled a distinguished team with experience in vaccine development, clinical trial operations, manufacturing, and commercialization, including prior experiencing developing HIL-214 at Takeda Pharmaceuticals.

Objectives / Overview:
This rolewill support late-stage drug substance manufacturing activities performed at the Contract Manufacturing sites to support the HIL-214 program and other programs as needed. This position will have responsibility for providing scientific/technical thought and contribution for author / review of documentation for clinical manufacturing, late-stage process validation and commercialization of drug substance at Contract Manufacturing Organizations (CMOs). This individual will work with a cross functional team across Tech Ops, including CMC Development, MSAT, Supply Chain, and Analytical Development teams to identify gaps and add manufacturing robustness for preparation of engineering lots, and GMP lots through PPQs.
We provide ample scientific challenges enabling you to have a real impact in an environment where you get the opportunity to take part in the entire biotech value chain from the earliest drug discovery all the way through late-stage clinical development and eventual commercialization.

Responsibilities:

• Contribute scientific and technical aspects to assist managing relationships with CMOs, CROs and key suppliers. This will include coordination, communication, and technical understanding to assist timely delivery of cGMP products to support clinical trials.
• Support the creation, development and review of gap assessments, late-stage product development and industrialization.
• Work closely with CDMOs to support and manage GMP batch manufacture and testing, support deviation investigations, batch review and release of GMP material.
• Assist in the review of Manufacturing Batch records and sampling plans in collaboration with the CDMO teams.
• Partner with Quality in development of documentation required to support validation and cGMP manufacturing for sterile products.
• Collaborate with Regulatory Affairs partners ensuring Health Authority requirements are satisfied.
• Partner with MSAT to drive vaccine technology transfer and scale-up of process improvements as required at the CMOs.
• Provide technical recommendations for evaluating process data, troubleshooting and root cause analysis as well as providing strategic recommendations leading to improved yields, cost of goods and process robustness.
• Travel as required to CMO and key vendors for Manufacturing oversight and partnership for commercialization purposes.
• Partner with key functions including Quality, Project Management, Clinical Operations, Finance and Regulatory Affairs.

Education, Experience & Skills:

• BS / MS in Chemical/Biochemical Engineering, Biochemistry, Chemistry or Biology with a minimum of 6-10 years in the GMP manufacturing environment (Ph.D. with minimum of 5 years).
• Experience / understanding of technical areas related to processes, unit operations and functions involved in drug substance manufacturing (e.g. Cell Expansion, Viral production, Yeast fermentation, SU Bioreactors, Harvest and Clarification)
• Direct experience in tech transfer and GMP manufacturing activities at the CDMOs
• Demonstrated ability to work effectively in a team-oriented CMC environment.
• Excellent communication skills, both written and oral.
• Knowledge of cGMP practices as applicable to technology transfer, manufacturing, drug substance, and analytical development.
• Proficiency in statistical software for data analysis and tracking and trending.
• Proven experience in a matrix environment is preferred.
• Demonstrated ability to work efficiently across multiple project teams and business functions.
• Demonstrated skills in Hillevax's Core Competencies:
  • Leadership
  • Drive, Intensity, Enthusiasm
  • Goal Orientation/Commitment to Task/Follow-up
  • Teamwork
  • Attention to Quality & Detail
  • Decision Making & Problem Solving
  • Flexibility

HilleVax is a biopharmaceutical company focused on the development and commercialization of novel vaccines. Our initial program, HIL-214, is a virus-like particle-based vaccine candidate in development for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection.
We initiated a Phase 2b study, NEST-IN1 to evaluate the safety, immunogenicity, and efficacy of HIL-214 in infants. In addition to infants, we also plan to seek approval of HIL-214 in additional age groups such as older children, adults, and older adults. We expect to report top-line data.
HilleVax has assembled a distinguished team with experience in vaccine development, clinical trial operations, manufacturing, and commercialization, including prior experiencing developing HIL-214 at Takeda Pharmaceuticals.

Objectives / Overview:
This rolewill support late-stage drug substance manufacturing activities performed at the Contract Manufacturing sites to support the HIL-214 program and other programs as needed. This position will have responsibility for providing scientific/technical thought and contribution for author / review of documentation for clinical manufacturing, late-stage process validation and commercialization of drug substance at Contract Manufacturing Organizations (CMOs). This individual will work with a cross functional team across Tech Ops, including CMC Development, MSAT, Supply Chain, and Analytical Development teams to identify gaps and add manufacturing robustness for preparation of engineering lots, and GMP lots through PPQs.
We provide ample scientific challenges enabling you to have a real impact in an environment where you get the opportunity to take part in the entire biotech value chain from the earliest drug discovery all the way through late-stage clinical development and eventual commercialization.

Responsibilities:

• Contribute scientific and technical aspects to assist managing relationships with CMOs, CROs and key suppliers. This will include coordination, communication, and technical understanding to assist timely delivery of cGMP products to support clinical trials.
• Support the creation, development and review of gap assessments, late-stage product development and industrialization.
• Work closely with CDMOs to support and manage GMP batch manufacture and testing, support deviation investigations, batch review and release of GMP material.
• Assist in the review of Manufacturing Batch records and sampling plans in collaboration with the CDMO teams.
• Partner with Quality in development of documentation required to support validation and cGMP manufacturing for sterile products.
• Collaborate with Regulatory Affairs partners ensuring Health Authority requirements are satisfied.
• Partner with MSAT to drive vaccine technology transfer and scale-up of process improvements as required at the CMOs.
• Prepare and review CMC sections of regulatory filings and interfacing with the regulatory agencies.
• Provide technical recommendations for evaluating process data, troubleshooting and root cause analysis as well as providing strategic recommendations leading to improved yields, cost of goods and process robustness.
• Travel as required to CMO and key vendors for Manufacturing oversight and partnership for commercialization purposes.
• Partner with key functions including Quality, Project Management, Clinical Operations, Finance and Regulatory Affairs.

Education, Experience & Skills:

• BS / MS in Chemical/Biochemical Engineering, Biochemistry, Chemistry or Biology with a minimum of 6-10 years in the GMP manufacturing environment (Ph.D. with minimum of 5 years).
• Experience / understanding of technical areas related to processes, unit operations and functions involved in drug substance manufacturing (e.g. Cell Expansion, Viral production, Yeast fermentation, SU Bioreactors, Harvest and Clarification)
• Direct experience in tech transfer and GMP manufacturing activities at the CDMOs
• Demonstrated ability to work effectively in a team-oriented CMC environment.
• Excellent communication skills, both written and oral.
• Knowledge of cGMP practices as applicable to technology transfer, manufacturing, drug substance, and analytical development.
• Proficiency in statistical software for data analysis and tracking and trending.
• Proven experience in a matrix environment is preferred.
• Demonstrated ability to work efficiently across multiple project teams and business functions.
• Demonstrated skills in Hillevax's Core Competencies:
  • Leadership
  • Drive, Intensity, Enthusiasm
  • Goal Orientation/Commitment to Task/Follow-up
  • Teamwork
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