Principal Scientist/Tech Transfer Lead

King of Prussia

Summary

Center for Breakthrough Medicines is seeking a highly motivated Principal Scientist, Tech Transfer Leads to provide leadership and guidance across the Process Development team and to direct the tech transfer activities from Client to Process Development to Manufacturing and Client to Manufacturing. This role will be responsible for providing operational and scientific oversight to the team, as well as work with a multidisciplinary group of engineers and scientists within the organization to ensure the seamless transfer of unit operations. The ideal candidate should be experienced in drug substance and/or drug product technology transfer, cGMP operations, and comfortable working in a fast-paced, entrepreneurial environment with broad responsibilities and opportunities. The Scientist must collaborate effectively with cross-functional teams including Process Development, Supply Chain and Manufacturing, as well as the Client to accomplish deliverables for technology transfer.

Responsibilities

Responsibilities

· Manage team of scientists and engineers responsible for tech transfers from Client to Process Development team and from Process Development team to Manufacturing

· Development of procedures, governance, and responsibilities associated with tech transfer process

· Serve as a scientific and technical lead for tech transfer related issues and investigations

· Partner with Quality, Engineering and Manufacturing to ensure robust process tech transfer plans, detailed process flow diagrams, manufacturing batch records, and campaign summary reports

· Assist in documenting changes/updates to pilot and manufacturing processes and working with required functions to implement those changes

· Provide technical leadership for the transfer of new products and processes to ensure smooth transition from process development into Pilot lab and GMP manufacturing

· Support regulatory filings and authorship of supportive source documents, establishment of control strategy, execution, and analysis

Education & Experience

· Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 5+ years’ experience, MS with 7+ years, BS with 9+ years

· Experience with tech transfer, process development, scale-up, pilot and GMP manufacture

· 2+ years viral vector/ vaccine drug substance tech transfer experience

· Experience working in and leading cross-functional teams

· Knowledge and/or experience in viral vector production, purification, or cell therapy is preferred.

· Experience in managing scientists and engineers of varying experience levels

· Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines

· Strong collaboration and interpersonal skills, including verbal and written communication, and ability influence

· Ability to work independently and as part of a matrixed team

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