Director of Downstream Process Development

3 weeks ago

Hopkinton, Massachusetts, United States Lake Pharma Full time
Job Summary

We are seeking a highly experienced Director of Downstream Process Development to lead our biologics process development team. The successful candidate will have a strong background in downstream process development, scale-up, technology transfer, and manufacturing, with a specific focus on chromatography and membrane filtration.

The ideal candidate will have a proven track record of scientific publications and conference presentations, as well as experience in leading and managing a team of bioprocess development scientists or engineers. They will be responsible for developing mammalian and RNA purification processes, process characterization, and process scale-up and scale-down for nonclinical studies.

The Director of Downstream Process Development will also be responsible for creating platform processes to minimize cost of goods, timeline, and yield losses. They will work closely with upstream process development, analytical development, manufacturing, and quality groups to ensure successful delivery of programs.

The successful candidate will have a strong technical focus and be able to drive innovation, technology development, and platform improvement to enhance productivity, quality, and consistency. They will also be responsible for presenting findings and results to senior management, external stakeholders, and industry leaders.

We offer a competitive salary and benefits package, as well as opportunities for career advancement and professional growth.

Responsibilities
  • Lead a group of scientists and engineers responsible for the development of mammalian and RNA purification processes and technology transfer to internal and external manufacturing sites
  • Responsible for successful mammalian and RNA process development, process characterization, and process scale-up and scale-down for nonclinical studies
  • Create platform processes to minimize cost of goods, timeline, and yield losses
  • Oversee process development and scale-up operations, define scale-down models, viral clearance study designs, and author associated regulatory filing documents
  • Design and execute Design of Experiments (DOEs) and Quality by Design (QbD) studies
  • Drive innovation, technology development, and platform improvement to enhance productivity, quality, and consistency
  • Present findings and results to senior management, external stakeholders, and industry leaders
  • Make strong technical and strategic contributions to cross-functional project teams
  • Build strong interfaces within biologics CMC community and drive adoption of best practices and ways of working
  • Ensure material specifications, process capabilities, yields, and manufacturing and scale-up strategies are sound for GMP products
  • Lead teams on troubleshooting and data analysis to solve technical problems in manufacturing to ensure manufacturing output and product quality
  • Support and lead risk assessments and manufacturing deviation investigations
  • Author, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed
Qualifications
  • Ph.D. in biological sciences, biochemistry, chemical engineering, or related field with a minimum of 8 years of relevant experience
  • Significant experience in leading and managing a team of bioprocess development scientists or engineers, demonstrating direct involvement in developing programs from early stages through IND
  • Expertise and strong technical knowledge in downstream process development, scale-up, technology transfer, and manufacturing, with a specific focus on chromatography and membrane filtration
  • Proven experience in process characterization using Design of Experiments (DOEs) and Quality by Design (QbD) concepts
  • Proven track record of scientific publications and conference presentations
  • Experience in antibody optimization, analytical characterization, and manufacturing for IND
  • Recognized leader in antibody/protein engineering and molecular biology as evidenced by publications, participation in international conferences, membership on journal editorial boards, etc.
  • Excellent communicator and highly effective in interacting with key internal and external stakeholders

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