1-617-500-6690 [email protected]

Company:  Confidential

Job Title: Upstream Bioprocess Optimization Lead (Sr./Pr. Engineer)

Job Number: 31130

Location: San Francisco, CA

Job Description

We are seeking a highly talented technical leader of our upstream bioprocess optimization team. The leader (Sr/Pr Engineer) will play a pivotal role in our bioprocess department.  The candidate is expected to build a dynamic and highly skilled process optimization team, work closely with the bioprocess leadership team to build a short/mid/long-term project portfolio, design and execute a wide range of process characterization and optimization studies, and collaborate with the technology transfer team to scale up and implement process improvements into GMP pilot plant operations.  Also, the candidate is expected to work closely with downstream bioprocess and cell line development teams, follow methodical process optimization and scale-up approaches to generate results.  The candidate will display teamwork, full alignment with strategic plans and agreed upon priorities, and passion for our mission.

The candidate is expected to keep abreast of new technologies and approaches and strategically employ these into the development, optimization, and implementation of a cost effective, robust and GMP compliant bioprocesses.

Responsibilities

  • Build a team of highly skilled scientists and engineers to drive process improvement activities in the areas of upstream process characterization and optimization (e.g., cell expansion, proliferation, differentiation, media, etc.)
  • Develop talents and provide clear directions to meet functional and strategic goals.
  • Build and manage a portfolio of strategic studies/projects to further improve upstream process performance
  • Develop project/study plans with clear goals, timelines, and resources
  • Lead and execute protocol-driven process improvement studies through effective utilization of DoE methodology, high throughput process optimization, scale up/down, process analytical technology (PAT), and process control strategies geared towards more robust and cost effective GMP pilot scale manufacturing processes
  • Effectively partner with all stakeholders (internal and external) to accomplish agreed upon goals
  • Fully document process development and improvement activities according to appropriate quality standards and in support of intellectual property development
  • Ensure data integrity and scientific rigor in R&D experiments
  • Support regulatory filings and regulatory audits as appropriate
  • Maintain awareness of cGXP, good scientific practices, follow and promote lab and office safety

Required Skills

  • Ph.D. or M.Sc. in Bioprocess/Biochemical Engineering or biochemical engineering and 2+ years or 5+ years, respectively, of hands-on bioprocess development experience
  • Hands on cell-culture based lab-scale and/or pilot-scale experience
  • Technical knowledge and hands-on experience in a combination of cell culture expansion, bioreactor process design/control, upstream, and cell harvest
  • Proven knowledge and expertise in DoE/statistical analysis (e.g., JMP or StatEase)Solid understanding of process scale-up and scale-down methodologies
  • Strong record of leading bioprocess optimization and scale up projects into implementation
  • Mindful of the current bioprocessing technology trends
  • Team player and effective communicator
  • People leadership and team building experience
  • Record of building internal/external partnerships
  • Experience in regulatory and quality considerations, including, but not limited to, establishment of Critical Process Parameters and Critical Quality Attributes, Chemistry, Manufacturing, and Controls compliance, and Biologics License Application submissions
  • Experience in food processing equipment and regulations
  • Experience in GMP-compliant process automation and Good Automated Manufacturing Practices

 

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