Manufacturing Staff Scientist (Upstream Bioprocess)
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.