Senior Director, Process Development

Beyond A Resume

Beyond A Resume is seeking a full-time Senior Director with Process Development experience for our Biotechnology client in Rockville, MD.

Job Description:

The Senior Director of Process Development will engage with both internal and external partners to lead Cell Therapy Process Development including preclinical, clinical stage, and commercialization of cell and gene therapy products. This position requires a strategic leader with experience in cell biology and/or immunology with a record of prior achievement in the development and manufacturing of large molecule biologics, cell and/or gene therapy products.

Reports To:

Vice President of Operations.

Job Responsibilities:

-Provide technical leadership of cell therapy process development, technology transfer and related cGMP manufacturing activities including process validation. Lead the development and technology transfer of cell therapy manufacturing and testing processes.

-Drive continuous improvement activities. Evaluate new technologies and innovate novel approaches to improve existing methods. Provide oversight of internal and external development projects and influence cross-functional partners to support process development objectives.

-Manage project timelines/scheduling and lead engagement with internal and external partners, including external contract development/testing laboratories. Track achievement of objectives and successes, identify risks and mitigation strategies, and implement rapid corrective action.

-Establish the product characterization, lot release and stability testing panels.

-Author/review/approve technical documents (SOPs, protocols, reports, risk assessments, specifications, etc.). Author and review technical and regulatory documents in support of CMC regulatory submissions (IND, BLA, etc.).

-Attract and retain skilled talent and mentor/train/encourage a team-centric environment with opportunities for skill development and personal growth.

-Work to build a positive culture with key internal team members, stakeholders, and external customers.

-Engage with both internal and external partners in the support of Process Development, preclinical, and clinical development of cell and gene therapies.

Job Requirements:

-PhD and 10+years of work experience; MS and 10+ years of work experience

-In-depth understanding of cellular biology and immunology with application to development of cellular processing and analytical methods.

-Familiarity with the following: flow cytometry/FACS, ELISpot, ELISA, cell culture/cell-based bioassays, microscopy. Prior experience developing potency and/or immunophenotyping test methods for cellular therapies.

-Experience leading process development organizations and supporting external manufacturing.

-Understanding of global regulatory requirements (FDA, EMA, ICH) for bioassay/potency, analytical method validation, comparability, and drug product stability.

-Competency in the application of statistical methods and tools for data analysis.

-Demonstrated leadership and critical thinking skills, and ability to motivate, manage, and influence team members with direct and indirect reporting status as part of CMC product development.

-Ability to work independently or as a team member to meet goals and commitments.

-Strong written and verbal communication skills are required. Experience translating complex scientific concepts and data into reports, presentations and CMC filings is required.

-Able to work onsite

*Relocation assistance is available for qualified candidates

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