Sr. Principal Scientist, Tech Transfer

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)

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.

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Your Contributions (include, but are not limited to):

• 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

Requirements:

• 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 typically leads junior levels and/or indirect teams

• Excellent interpersonal communication, problem-solving, and analytical thinking skills

• Sees broader picture and longer-term impact on division/company

• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

• Excellent project management, strong project leadership skills

• Ability to influence all levels of the organization and external resources

#LI-DM1

Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.

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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. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.