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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: HillevaxArcaea
Boston, MA, United States
Arcaea is a biology-first beauty company building a new ingredient toolset for the beauty and personal care industry. We are creating pioneering ingredients, products, and stories accessible uniquely through biology. Arcaea is building a new ingredient toolset for the beauty and personal care industry - one rooted in biotechnology with the aim of
Job Source: ArcaeaHilleVax, 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
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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
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:
Providing expertise for the scale up, tech transfer, GMP run readiness of downstream unit operations in support of clinical/commercial manufacturing of HilleVax's vaccine products.
Manage CDMOs for Downstream tech transfer timelines and deliverables
Acting as a cross-functional subject matter expert in the organization to promote scientific and operational excellence
Responsibilities:
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
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 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
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 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.
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 client 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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Email Alert for Senior Scientist, Downstream Process Development jobs in Boston, MA, United States
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