Manufacturing Staff Scientist (Upstream Bioprocess)

Ascent Services Group
September 15, 2020
Hercules, CA
Job Type


Manufacturing Staff Scientist (Upstream Bioprocess)
Hercules, CA

We are looking for a Staff Scientist with extensive experience in upstream bioprocess development and troubleshooting for the Reagents Manufacturing Process Development team. The individual will execute cross-functional projects related to development and continuous improvement for our product lines with a focus on Protein Chemistry and Molecular Biology Reagents, digital PCR reagents and the Bio-Plex suspension array system.

The successful candidate will utilize his/her expertise in upstream bioprocess to support new products for transfer into manufacturing, to troubleshoot existing manufacturing processes, and to introduce improvements in material sourcing and manufacturing processes.


  • Upstream Process Development will be responsible for planning, development, optimization, execution and management, as well as working with R&D, Manufacturing and CMOs.
  • Provide technical expertise and scientific knowledge for design, development, optimization and production of Proteins.
  • Act as primary lead in developing scalable and reproducible processes capable of GMP Production.
  • Previous experience setting up GMP facility desirable.
  • Develop and optimize robust, high yield and scalable processes for the production of recombinant proteins from E. coli and mammalian cell culture.
  • Extensive experience with the setup and operation of lab-scale controlled bioreactor for medium and high density batch & bed-batch Fermentation.
  • Establish bioreactor based fermentation and development product recovery processes from 10L to 500L.
  • Knowledge and experience with the design and testing of growth medium formulations.
  • Develop and characterize cell lines, evaluate stability and suitability for large scale manufacturing.
  • Lead & establish project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Action Plan, Risk Analysis, etc.)
  • Lead and/or manage projects that comprise team members from cross functional areas.
  • Design experiments to meet requirements, support manufacturing and transfer both internal and external processes.
  • Drive development & execution of complex experiments & tests (including writing & executing protocols) to qualify & validate manufacturing processes; analyze results, make recommendations, & develop reports.
  • Oversee manufacturing support tasks; give instruction to engineers/ technicians on conducting tests; train engineers/ technicians & provide feedback & coordinate engineer/ technician work.
  • Advise, review experimental design, protocol, and reports of fellow scientists.
  • Mentor technical personnel in process capability, developing training & technical documentation for production to enable the seamless project & process knowledge transfer.
  • Lead efforts to identify & ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., Six Sigma & LEAN methods) employing technical design skills ensure equipment, tools, fixtures, processes are characterized and lean.
  • Lead efforts to drive operational excellence, leveraging data to identify improvement opportunities and ensuring implementation of well-engineered solutions
  • May serve as an Independent Reviewer for design review or lead automation, and leading edge process improvement, and/or provide process strategic guidance to the management team.
  • Lead team to resolve complex CAPA, analyze & resolve complex Manufacturing & compliance issues (e.g., CAPA, non-conformances, audit observations)
  • Works in a team environment, including frequent inter-organizational & outside customer contacts.
  • Represents organization in providing solutions to difficult technical issues associated with specific projects and contracts.
  • Interacts with senior external representatives on significant technical matters often requiring coordination between organizations.
  • Represents manufacturing in key quality management system such as Design Review Board, Change Control Board, Validation Review Board, etc.


  • Master's Degree and/or Doctorate Degree in Engineering field in bioprocessing or Scientific field in chemistry, biology or biochemistry with
  • Minimum of 6+ years industry experience is highly desirable for this position.
  • Proven expertise in usage of MS Office Suite; DOE methods preferred.
  • Excellent documentation, communication skills, & interpersonal relationship skills including negotiating & relationship management skills.
  • Ability to translate technical information to all organization levels.
  • Extensive knowledge of engineering and scientific principles, theories, & concepts.
  • Advanced problem solving in organizational, analytical, & critical thinking skills.
  • Extensive to expert level understanding of processes, equipment, and methods in 2-3 technical areas.
  • Strong leadership skills in a technical area to influence process improvement & change.
  • Able to apply scientific training to solve manufacturing and operational issues.
  • Ability to build relationships through inter-organization collaboration.
  • Experience with ERP system SAP preferred.
Drop files here browse files ...

Related Jobs

September 20, 2020
September 20, 2020
Property Manager   Oakland, CA new
September 20, 2020
Chief Marketing Officer   Menlo Park, CA new
September 20, 2020
Manufacturing Engineer   Union City, CA new
September 20, 2020