(Sr.) Scientist Viral Vaccine Process Development (Upstream)

Company

Barrington James

Job type

Full time

Location
Massachusetts
USA

Company profile
My client is a biopharmaceutical product development services organization, based in The
Netherlands and USA where it has R&D and GMP manufacturing capabilities, that actively
develops and offers unique know-how and technologies aimed at bringing biopharmaceuticals
to the market more rapidly and at lower cost.
The company is actively involved in major global health initiatives where it collaborates with
funding organizations like BMGF, PATH, CEPI and IAVI and Developing Country Vaccine
Manufacturers, helping to bring more affordable medicines to the market.
They have a specific focus on viral and vector-based vaccines and to support program
expansion in this area it is seeking experienced people for its Woburn (MA) R&D site.

The position
We are looking for a (Sr.) Scientist experienced in Viral Vaccine Upstream Process
Development to work in a small Upstream Process Development Team. The team collaborates
closely with the Downstream Process Development and Analytical Development teams as
well as QA. Processes developed by the team will be transferred either to the GMP
manufacturing site in Leiden, The Netherlands or to Developing Country Vaccine
Manufacturers, so good communication and documentation skills are required. Knowledge of
bioreactor and cell culture techniques using cell lines including VERO, MRC-5 and HEK293
are essential.
In our startup culture, the ideal candidate will show entrepreneurial spirit, independence and
ability to take strategic, calculated risks to guarantee efficient progression of the projects and
help build the team and the US operations. This innovator will be motivated by assessing and
implementing new manufacturing technologies to keep ahead of the competition. Agility,
flexibility and will to contribute to projects that have a strong impact on global health are key
components of the culture.

Responsibilities:

  • Technical leadership in the development of scalable, robust, high yielding, and economically viable cell culture processes using a range of adherent and suspensionbased cell culture systems for the production of viral and vector-based vaccines.Processes will be developed at bench scale and scaled-up to clinical scale prior to tech transfer.
  • Knowledge of process monitoring and control strategies, Design-ofExperiments experimental set up and different process types including perfusion will be necessary.
  • Process documentation suitable to allow tech transfer to GMP manufacturing (within the company or to external manufacturer)
  • Cost-of-Goods analysis using tools such as Biosolve.
  • Collaboration and coordination with other teams including downstream process development, analytical development and formulation development.
  • Manage, train, guide and coordinate activities of junior staff members.
  • Participates in and provide information to project team meetings.
  • The position may entail travel to other sites or tech transfer recipients.

Education and experience:

  • B.S./M.S. or Ph.D.
  • 10+ years (B.S./M.S.) or 6+ year (Ph.D.) of related experience working in biopharmaceutical industry focusing on viral vaccine or viral vector production.
  • Significant experience in developing and optimizing scalable viral or vector-based vaccine processes including knowledge of upstream process development scaleup/scale-down, bioreactor set-up, operation and control strategies and aseptic bioprocessing.
  • Experience operating in early and late stage clinical process development, ideally with experience of contract development and manufacturing.
  • Ability to adapt to change and effectively deliver under pressure while maintaining a high level of work quality.
  • Strong verbal and written communication skills and ability to communicate within the organization as well as externally. Strong process documentation skills.
  • Ability to use DoE in Design Expert, or other for statistical experimental design, data analysis and knowledge of statistical process control, QbD, and PAT concepts. Ability to perform CoGs analysis using tools such as Biosolve.
  • Familiarity with FDA guidance and quality systems.

You will join a stimulating and international team working in a highly collaborative environment within global consortia. As part of this group, personal as well as scientific growth are encouraged and developed. In this position, you will report to the Associate Director of Upstream Process Development.

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