Sr. Principal Scientist, Tech Transfer
Neurocrine Biosciences
5 hours ago
On-site
San Diego, CA
Operations
About The Role
Responsible for leading and supporting the transfer of development processes into GMP manufacturing, ensuring technical readiness, compliance, and operational success. Serves as a key technical interface between R&D, Manufacturing, Quality, Regulatory, and external partners. Plans and executes technology transfer activities, authors technical documentation, manages risks, and supports manufacturing readiness across clinical and commercial stages. Participates in departmental/operational strategies and mentors junior scientists.
Your Contributions (Responsibilities)
- Lead and support technology transfer activities from R&D to GMP manufacturing
- Develop, execute, and maintain technology transfer plans, timelines, and deliverables
- Serve as technical subject matter expert for process and manufacturing technologies during transfer and scale-up
- Author, review, and approve technology transfer documentation (protocols, reports, gap analyses, risk assessments)
- Provide technical oversight and troubleshooting during engineering runs, clinical trial manufacture, and validation
- Ensure technology transfer activities comply with GMP, ICH, and internal quality system requirements
- Manage interactions with external partners, vendors, and CDMOs
- Contribute to department strategies and policies
- Plan and manage projects and teams; represent the function on cross-functional teams
- Maintain accountability for deliverables including production plans
- Lead risk assessments to support project advancement
- Independently design, plan, and execute complex activities supporting preclinical through commercial work
- Identify process/product challenges and lead optimization/troubleshooting experiments
- Create and implement ideas to improve quality, stability, manufacturing consistency, or cost effectiveness
- Provide input into CMC regulatory documentation
- Build and enhance internal and external professional relationships
- Lead and mentor lower-level scientists/team members
- Other duties as assigned
Requirements
- BS/BA in biotechnology, chemical engineering, biological sciences, or similar + 12+ years relevant experience OR
- MS/MA in biotechnology, chemical engineering, biological sciences, or similar + 10+ years relevant experience OR
- PhD in biotechnology, chemical engineering, biological sciences, or similar + 8+ years relevant experience
- Working knowledge of GMP manufacturing environments and quality systems
- Experience authoring and executing technology transfer plans, protocols, and reports
- Understanding of 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/product development strategies and current techniques/literature
- Good knowledge of cross-functional requirements related to drug development
- Ability to lead teams and direct development programs; strong strategic planning
- Ability to meet multiple deadlines with accuracy and efficiency
Compensation & Benefits (as stated)
- Annual base salary: $156,900.00–$214,000.00
- Annual bonus with target of 30% of earned base salary; eligibility for equity-based long-term incentive
- Retirement savings plan (with company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave
- Health benefits: medical, prescription drug, dental, and vision
Responsible for leading and supporting the transfer of development processes into GMP manufacturing, ensuring technical readiness, compliance, and operational success. Serves as a key technical interface between R&D, Manufacturing, Quality, Regulatory, and external partners. Plans and executes technology transfer activities, authors technical documentation, manages risks, and supports manufacturing readiness across clinical and commercial stages. Participates in departmental/operational strategies and mentors junior scientists.
Your Contributions (Responsibilities)
- Lead and support technology transfer activities from R&D to GMP manufacturing
- Develop, execute, and maintain technology transfer plans, timelines, and deliverables
- Serve as technical subject matter expert for process and manufacturing technologies during transfer and scale-up
- Author, review, and approve technology transfer documentation (protocols, reports, gap analyses, risk assessments)
- Provide technical oversight and troubleshooting during engineering runs, clinical trial manufacture, and validation
- Ensure technology transfer activities comply with GMP, ICH, and internal quality system requirements
- Manage interactions with external partners, vendors, and CDMOs
- Contribute to department strategies and policies
- Plan and manage projects and teams; represent the function on cross-functional teams
- Maintain accountability for deliverables including production plans
- Lead risk assessments to support project advancement
- Independently design, plan, and execute complex activities supporting preclinical through commercial work
- Identify process/product challenges and lead optimization/troubleshooting experiments
- Create and implement ideas to improve quality, stability, manufacturing consistency, or cost effectiveness
- Provide input into CMC regulatory documentation
- Build and enhance internal and external professional relationships
- Lead and mentor lower-level scientists/team members
- Other duties as assigned
Requirements
- BS/BA in biotechnology, chemical engineering, biological sciences, or similar + 12+ years relevant experience OR
- MS/MA in biotechnology, chemical engineering, biological sciences, or similar + 10+ years relevant experience OR
- PhD in biotechnology, chemical engineering, biological sciences, or similar + 8+ years relevant experience
- Working knowledge of GMP manufacturing environments and quality systems
- Experience authoring and executing technology transfer plans, protocols, and reports
- Understanding of 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/product development strategies and current techniques/literature
- Good knowledge of cross-functional requirements related to drug development
- Ability to lead teams and direct development programs; strong strategic planning
- Ability to meet multiple deadlines with accuracy and efficiency
Compensation & Benefits (as stated)
- Annual base salary: $156,900.00–$214,000.00
- Annual bonus with target of 30% of earned base salary; eligibility for equity-based long-term incentive
- Retirement savings plan (with company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave
- Health benefits: medical, prescription drug, dental, and vision