Sr. Scientist/Principal Scientist, Product Development Biologics

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:

We are looking for an experienced, motivated and proven Principal to build our biologics formulation capability with a focus on antibody and gene therapy Drug Product (DP) development and delivery. This position provides technical leadership on biological DP development, including formulation, manufacturing processes, characterization and both internally and through external CDMO partners.
The Chemistry, Manufacturing and Controls (CMC) Product Development (PD) team is highly collaborative and integrated with a global development supply chain/network of highly qualified CDMO partners. This individual will be an integral part of ongoing efforts to discover, develop, deliver, and commercialize biopharmaceutical large molecule therapeutics. This is a unique opportunity to work with a growing drug discovery and development team in the heart of San Diego’s biotechnology community.

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

• Technical design and execution of biologics ( including antibody and/or AAV) drug product development workstreams, focusing on formulation, manufacturing process development, testing, stability and portability to device strategy.

• Partner with cross-function teams enterprise-wide including CMC, Research, Preclinical, Regulatory/Quality and Clinical to ensure high-quality, on-time deliveries of DPs to meet program timelines.

• Prepare, author and review/edit regulatory submissions (including INDs/IMPDs/CTAs, BLAs, briefing packages or other regulatory dossiers), technical reports, risk assessments and scientific publications.

• Establish and grow internal capabilities for biologics DP development to accelerate, enable and inform the outsourced drug product development and manufacturing workstreams.

• As a technical lead, assist supervisor/director to manage priorities and timelines while also creating value by innovating designs that generate new IP, honoring QbD principles along the way.

• Manage internal biologics manufacturing and testing capabilities within the Product Development Department, including sourcing & procuring instruments and equipment required to perform process and analytical studies.

• Provide instrument/equipment and method training for other personnel to promote broad utilization of analytics capabilities within PD department and CMC.

• Proactively researches drug product manufacturing processes based on current Regulatory and ICH guidelines for modern pharmaceutical development.

• Support biologics drug product life cycle management.

• Search, assess and share/teach up-to-date scientific and technical knowledge and information of various biologics formulation/process approaches related to the company’s drug product development programs

Requirements:

• BA/BS degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field and 8+ years (Sr. scientist) /12+ years (principal scientist) of pharmaceutical industry experience OR

• Master's degree in Pharmaceutics, Chemistry, Biochemistry, Biology, Chemical Engineering, or related field preferred and 6+ years (Sr. scientist) /10+ years (principal scientist) of similar experience noted above OR

• Ph. D. (preferred) in Pharmaceutics, Analytical Chemistry, Chemistry and 1+ years (Sr. scientist) /6+ years (principal scientist) similar experience noted above

• Thorough understanding of protein chemistry principles and design of various formulations (preferred experience in both AAV and antibodies) is required.

• Extensive hands-on experience and knowledge of various formulations for antibody and/ or AAV capsid is required.

• Candidate must exhibit the technical ability to execute and troubleshoot experiments through rational and critical thinking.

• Must be highly organized and detail oriented.

• Excellent capability in strategic thinking and Planning.

• Hands-on experience with analytical techniques used for protein characterization and stability testing is required.

• Experience with regulatory submission and relevant guidelines is preferred.

• Prior experience in device compatibility, in-use stability, and dose formulation analysis is preferred.

• Working knowledge in applying QbD principles in drug product development is preferred.

• Prior CMC development experience in fill finish, lyophilization process development, drug delivery is a plus.

• Good understanding of health authority regulations and guidelines for drug product development and approval processes is a plus.

• Technical writing: protocols, reports, risk assessments, regulatory filings, SOPs, etc.,

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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 $128,200.00-$185,900.00. 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.