Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, 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 more than 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, Facebook and YouTube. (*in collaboration with AbbVie)

About the Role:

We are seeking an experienced Senior Principal Engineer, Tech Transfer to provide scientific and technical leadership for the successful transfer of parenteral drug product manufacturing processes from development into GMP manufacturing. This is a highly visible role that partners across Research & Development, Technical Operations, Quality, Regulatory Affairs, and external manufacturing organizations to ensure robust, compliant, and scalable manufacturing processes that support clinical and commercial success.

As a Senior Principal Engineer, you will serve as a recognized technical leader responsible for driving technology transfer strategy, execution, and manufacturing readiness across multiple development programs. You will leverage deep expertise in sterile drug product development, process scale-up, and GMP manufacturing while mentoring scientists and influencing cross-functional teams to deliver high-quality outcomes.
This role offers the opportunity to shape manufacturing strategy, solve complex technical challenges, and directly impact the successful delivery of innovative therapies to patients.

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

• Lead technology transfer activities for parenteral drug products from development through GMP manufacturing.

• Develop comprehensive technology transfer strategies, project plans, timelines, and execution plans.

• Serve as the technical subject matter expert for drug product manufacturing processes during process transfer and scale-up.

• Author and review technology transfer protocols, reports, risk assessments, gap analyses, and technical documentation.

• Provide scientific leadership during engineering batches, clinical manufacturing, process validation, and commercial readiness activities.

• Partner closely with Quality, Regulatory Affairs, Research & Development, Technical Operations, and external CDMOs to ensure successful process implementation.

• Lead technical investigations and troubleshooting activities to resolve manufacturing and process challenges.

• Ensure technology transfer activities comply with GMP regulations, ICH guidance, and internal quality systems.

• Support Chemistry, Manufacturing, and Controls (CMC) regulatory documentation.

• Identify opportunities to improve manufacturing robustness, product quality, efficiency, and scalability.

• Lead complex cross-functional initiatives and influence strategic technical decisions across multiple development programs.

• Mentor and develop junior scientists while fostering scientific excellence and collaboration.

• Other duties as assigned

Requirements:

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

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

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

• Extensive experience supporting parenteral drug product development and technology transfer within the biotechnology or pharmaceutical industry.

• Strong understanding of sterile manufacturing processes, process development, scale-up, validation, and commercial manufacturing.

• Experience leading technology transfers across internal manufacturing sites and external CDMOs.

• Working knowledge of GMP manufacturing, quality systems, and regulatory expectations.

• Experience authoring technical documentation including protocols, reports, risk assessments, and technology transfer packages.

• Demonstrated success leading complex cross-functional technical projects.

• Excellent scientific communication, project leadership, and stakeholder management skills.

Preferred Qualifications

• Deep expertise with sterile fill-finish technologies and container closure systems.

• Experience supporting multiple parenteral drug product modalities.
  Knowledge of ICH Q8, Q9, and Q10 guidelines.

• Experience supporting CMC regulatory submissions.
  Proven ability to mentor scientists and influence technical strategy across organizations.

• Demonstrated success partnering with global contract development and manufacturing organizations (CDMOs).

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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.