Sr. Principal Scientist, Tech Transfer

About the role

Leads the design and execution of complex formulation and process development activities across the full product lifecycle, from early discovery through commercialization, delivering phase-appropriate, high-quality drug products that address molecule-specific challenges and target product profiles.

Oversees end-to-end development including formulation screening, scale-up, process optimization, validation, and technology transfer to CDMOs, while establishing and managing external partnerships to support clinical and commercial programs.

Provides strategic and technical leadership within CMC teams, driving cross-functional alignment, regulatory readiness, and continuous improvement, while mentoring team members and ensuring robust control strategies for long-term product performance and supply.

Responsibilities

• Lead formulation and process development across the product lifecycle, designing and optimizing phase-appropriate, robust drug product formulations and manufacturing processes aligned with target product profiles and program objectives.
• Serve as the technical and strategic lead within CMC teams, guiding scientific strategy, managing subteams, and driving program execution through effective planning, communication, and decision-making.
• Oversee process development activities including experimental design (DoE), scale-up, validation, and global technology transfer, ensuring successful execution from early development through commercial manufacturing.
• Provide subject matter expertise to investigate and resolve complex technical challenges, applying innovative and data-driven approaches to overcome development obstacles and ensure product quality.
• Establish and manage external partnerships (e.g., CDMOs, CROs), including selection, oversight, and performance management to ensure technical capability, compliance, and reliable supply.
• Act as company representative during manufacturing campaigns and external engagements (“person-in-plant”), ensuring operational excellence and alignment with development and commercial goals.
• Drive cross-functional collaboration with internal teams and external partners to advance programs efficiently and ensure seamless knowledge transfer.
• Lead development and execution of CMC regulatory strategies, including authorship, review, and oversight of submissions, ensuring compliance with global regulatory requirements and scientific integrity.
• Implement lifecycle management strategies, including continuous process verification, continuous improvement, and proactive risk management for critical process parameters and quality attributes.
• Identify and implement new technologies, equipment, and development approaches to enhance organizational capabilities, innovation, and competitiveness.
• Establish and maintain effective knowledge management systems, documentation standards, and best practices to support data integrity, accessibility, and regulatory readiness.
• Provide leadership, mentorship, and technical guidance to team members, while influencing broader organizational strategy and representing the company in external scientific and regulatory forums.

Requirements

• BA/BS degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field and 8+ years of experience in the pharmaceutical industry in a chemistry, analytical, or characterization laboratory setting OR Master's degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field preferred and 6+ years of similar experience noted above OR PharmD preferred and 4+ years of similar experience noted above.
• Must have in-depth knowledge and a thorough understanding of cGMPs relating to drug product manufacturing and regulatory guidelines and processes and a strong quality mindset.
• Extensive hands-on experience with solid dosage form manufacturing processes.
• Demonstration of cross-functional understanding related to drug development.
• Significant technical expertise in formulation development, specifically formulation of solid dosage forms such as tablets or capsules.
• Expert familiarity with analytical methods, validation, technology transfers and stability programs are needed.
• Management experience in strategic planning, budgets, project management plus regulatory experience in preparing and authoring the drug product sections of INDs and NDAs.
• Holds self accountable for mistakes of self and department and can set targets and articulate results.
• Assimilates data and research findings outside of Neurocrine for application to new scientific projects.
• Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas.
• May develop an understanding of other areas and related dependencies.
• Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools.
• Ability to work as part of and lead multiple teams.
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams.
• Excellent computer skills.
• Excellent communications, problem-solving, analytical thinking skills.
• Sees broader picture, impact on multiple programs, teams and/or departments.
• Able to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
• Excellent project management and leadership skills.

Pay

The annual base salary we reasonably expect to pay is $156,900.00-$214,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills.

Benefits

• Retirement savings plan (with company match)
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.