Sr. Principal Scientist, Tech Transfer

About the Role:

Responsible for leading and supporting the transfer of development processes into GMP manufacturing, ensuring technical readiness, compliance, and operational success. This role serves as a key technical interface between R&D, Manufacturing, Quality, Regulatory, and external partners to ensure robust, compliant, and efficient process implementation. The individual will be responsible for planning and executing technology transfer activities, authoring technical documentation, managing risks, and supporting manufacturing readiness across clinical and commercial stages.

Participates in the development of departmental and operational strategies. Serve as a mentor and advisor for junior scientists.

• Lead and support technology transfer activities from R&D to GMP manufacturing

• Develop, execute, and maintain technology transfer plans, timelines, and deliverables to ensure successful process transfer

• Serve as the technical subject matter expert for process and manufacturing technologies during transfer and scale‑up

• Author, review, and approve technology transfer documentation, including protocols, reports, gap analyses, and risk assessments

• Provide technical oversight and troubleshooting support during engineering runs, clinical trial manufacture, and validation

• Ensure all technology transfer activities comply with GMP, ICH, and internal quality system requirements

• Manage interactions with external partners, vendors, and CDMOs, including technical discussions and issue resolution

• Significantly contributes to the development of department strategies and policies

• Plans and manages projects and project teams. Represents the broader department and the function at cross‑functional teams

• Maintains accountability for deliverables including production plans for development projects

• Leads risk assessments to support project advancement

• Independently designs, plans and executes complex activities towards the goals of one or more development projects to support preclinical through commercial activities

• Proactively identifies process or product challenges and leads necessary optimization activities including trouble‑shooting experimentation

• Creates and implements novel ideas to improve product quality, product stability, manufacture consistency, or to achieve cost effectiveness

• Provides input into CMC regulatory documentation and supporting work

• Build and enhance internal and external professional relationships

• Leads and mentors lower‑level scientists and/or team members

• Other duties as assigned

• BS/BA in biotechnology, chemical engineering, biological sciences, or similar scientific discipline and 12+ years of relevant experience OR

• MS/MA in biotechnology, chemical engineering, biological sciences, or similar scientific discipline and 10+ years of relevant experience OR

• PhD in biotechnology, chemical engineering, biological sciences, or similar scientific discipline and 8+ years of similar experience noted above

• Working knowledge of GMP manufacturing environments and quality systems

• Experience authoring and executing technology transfer plans, protocols, and reports

• Understands process development, transfer, and validation and risk management principles

• Experience supporting external manufacturing partners (CDMOs)

• Familiarity with ICH Q8/Q9/Q10 guidelines

• Advanced understanding of process or product development strategies as well as current techniques and literature

• Good knowledge of cross‑functional requirements related to drug development

• Ability to lead teams and direct development programs

• Excellent at strategic planning

• Maintains substantial knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas

• Acts as a technical lead on various projects

• Applies understanding of the team’s place in the larger organization, and discusses changes, progress, and issues as they relate to other areas

• May utilize working knowledge of other related disciplines to provide solutions to a wide range of difficult problems

• Ability to work as part of and lead multiple teams

• Good leadership, mentoring skills, and abilities…