Director, Process Development

United States·South San FranciscoFull Timeexecutive

OtherDevelopment

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Overview

Position Summary Cellares is seeking an innovative and highly motivated Director to lead enterprise client programs within the Process Development team. The candidate will have extensive experience in cell therapy manufacturing, personnel oversight and client relationship management.

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Position Summary

Cellares is seeking an innovative and highly motivated Director to lead enterprise client programs within the Process Development team. The candidate will have extensive experience in cell therapy manufacturing, personnel oversight and client relationship management. This individual will interface across many parts of the company and with customers to translate existing client drug product manufacturing processes onto the Cell Shuttle manufacturing platform.

The successful candidate will be responsible for managing and developing scientists and research associates, as well as supporting technology transfer and ongoing research and development activities. Extensive experience in experimental design, process development, process characterization, MSAT and cell/gene therapy manufacturing are required. The ideal candidate will be well acquainted with developing scalable processes and transferring them from the development space into manufacturing.

Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Developing and leading the Enterprise Programs team within the PD department

Managing tech transfer and process development activities to enable regulatory filing

Serving as the company’s internal subject matter expert with regards to cell therapy manufacturing questions associated with all Enterprise Programs

Assuming responsibility for tracking and planning resource allocation, budgets, headcount and continuous team, process and technology improvements

Developing best practices, templates, and standards for transitioning processes from development into characterization and, ultimately, manufacturing

Planning the process development team’s work for the quarters to come with clearly defined goals and resourcing plans

Performing gap analyses and translating existing manual and/or automated processes onto the Cell Shuttle platform

Performing and supporting in the execution of verification, validation, and performance qualification

Authoring standard operating procedures, protocols, and batch records for the manufacturing of Enterprise Program cell therapies

Working with our Analytical Development team to assess and quantify the quality of cell therapy manufacturing process steps in meeting Enterprise Program client requirements

Authoring high-quality regulatory submissions and technical reports; independently prepare and present data/findings at department, project team, and senior management meetings

PhD, M.S. or B.S. in biological sciences (Molecular Biology, Immunology, Genetics)

Excellent organizational and communications skills and strong ability to lead and work with individuals across all levels in the organization

4+ years of experience in the cell and gene therapy manufacturing or process development space, with at least two years in an industry setting.

Extensive experience with different modalities of genetically modified cell therapies (e.g. CAR-T, TCR, HSCs, CD34+)

Experience with both autologous and allogeneic cell therapy manufacturing workflows in preclinical, clinical and/or commercial environments

Experience representing companies externally, with strong client relationship management skills

Experience with managing and growing process development teams and processes

Strong experimental design and troubleshooting skills, able to distill complex scientific information into simple and actionable final reports

Experience working in a GMP environment and familiarity with quality requirements

Demonstrated experience in process optimization, characterization and tech transfer

Excellent data analysis skills and experience with a variety of scientific software applications

Great verbal and written communication skills and the ability to interpret, summarize, and present scientific results in a clear, concise, accurate manner to both technical and non-technical audiences

Must be able to travel up to 15% of the time

Self-awareness, integrity, authenticity and a growth mindset

Experience interfacing with the FDA

PhD / post-doctoral experience in the gene/cell therapy field

Experience authoring CMC sections for IND, IMPD and NDA

Proven track record of utilizing management and process improvement tools (daily management, problem solving & root cause analysis tools, value stream mapping etc.) to meet and exceed strategic business objectives