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HilleVax, Inc.
Boston, MA, United States
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 mil
Job Source: HilleVax, Inc.Hillevax
Boston, MA, United States
Senior Scientist, Downstream 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 infectio
Job Source: HillevaxHillevax
Boston, MA, United States
Sr. Scientist, Upstream Process Development HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our 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
Job Source: HillevaxEPM Scientific - Phaidon International
Boston, MA, United States
SUMMARY This clinical-stage biopharmaceutical company is looking for an innovative scientist with a strong background in Upstream Process Development to oversee the development of all upstream technical activities for their lead vaccine program. They will also be expected to oversee CRO/CDMOs to make sure all areas of the drug substance process dev
Job Source: EPM Scientific - Phaidon InternationalHilleVax, Inc.
Boston, MA, United States
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 mil
Job Source: HilleVax, Inc.Hillevax
Boston, MA, United States
Research Associate, Downstream 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 infect
Job Source: HillevaxHireMinds
Boston, MA, United States
Our clinical stage pharmaceutical client here in Boston, MA is building out their Process Development team and looking to add a Research Associate, Downstream PD to their team (onsite 3-4 days/week)! Responsibilities include but not limited to: Serve as subject matter expert on chromatography and filtration unit operations. Execute process deve
Job Source: HireMindsGarudatx
Burlington, MA, United States
Garuda Therapeutics, a biotechnology company focused on developing off-the-shelf human hematopoietic stem cell-based cellular therapies, is seeking a highly motivated associate / senior associate to join its growing team. The full-time role will be a key member of the process development team, focusing on scaling up pluripotent stem cell expansion
Job Source: GarudatxBoston, MA, United States
Our clinical stage, pharmaceutical client here in Boston, MA is growing and looking to add a Sr. Scientist, Downstream Process Development to their team (onsite 3-4 days/week)! This role will be responsible for providing expertise for the scale up, tech transfer, GMP run readiness of downstream unit operations in support of clinical/commercial manufacturing vaccine products. Will manage CDMOs for Downstream tech transfer timelines and deliverables and act as a cross-functional subject matter expert in the organization to promote scientific and operational excellence. Other responsibilities include but not limited to:
* Lead process design, development and scale up of downstream unit operations including column chromatography, ultrafiltration, virus clearance and TFF operations.* Drive design, development and execution of studies to support life cycle management and continuous improvement initiatives.* Provide technical assessment to enable selection of drug substance Contract Development and Manufacturing Organizations (CDMO).* Supporting ongoing technical transfer and manufacturing at CDMOs through acting as the person in the plant and providing technical oversight to assist with troubleshooting.* Support root cause investigations and deviation management in partnership with Quality.* Drive process characterization studies to map design space (PARs and NORs) at the CDMOs.* Serving as a subject matter expert for purification unit operations to both internal and external stakeholders.* Working with internal resources to identify potential improvements for existing downstream processes.* Work closely with CDMO partners and technical team on process design, optimization and characterization, provide technical guidance, oversight, and troubleshooting to ensure CDMO partners successfully develop a robust/efficient process, ensure timely delivery of clinical materials as per required timeline and seamless paths towards successful regulatory submissions.* Author and review CMC sections of regulatory submissions, technical reports crucial for filing and responding to questions from regulatory submissions.
Requirements:
* 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 downstream process development, scale up and tech transfer of GMP operations is required.* Direct experience with recombinant VLPs or vaccines is highly desirable* Some experience working with CDMOs is nice to have* Proven experience in managing and coordinating both internal and external deliverables.* Demonstrated technical expertise in purification of recombinant proteins utilizing column chromatography and tangential flow filtration.* 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.
Other:
* Seeking Boston local candidates to be on-site 3-4 days per week.* Willingness to travel to various meetings or client sites, including overnight trips (up to 10%).*
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Email Alert for Sr. Scientist, Downstream Process Development jobs in Boston, MA, United States
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