Assoc. Director, Biologics Lead Optimization

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, but few options.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. 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, 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 (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

Responsible for leading a team to carry out research-level early process development for biologics including antibodies and gene therapies. The team is charged with both providing research scale material to in vivo pharmacology and with scaling up material for non-human primate studies while providing initial process methods to CMC colleagues to speed development. The team encompasses mammalian expression and purification of antibodies and AAV gene therapies using state-of-the-art technologies. The candidate will be expected to lead the team in further optimization of existing processes as well as in the infusion of novel technologies into workflows. Will collaborate closely with research and development analytical teams to ensure appropriate supply of material for analytical development and to ensure suitable methods are being applied to in-process testing. Expected to participate in developability assessments for potential clinical development candidates and contribute to selection of final candidate. Collaborates with CMC and strategizes with key stakeholders, including Chemical Development, Product Development, Analytical Development, Clinical Trail Material Supply Chain, QA, and Regulatory CMC.

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

• Leads expression and purification teams in producing material for exploratory research and POC non-human primate studies

• Responsible for resource allocation to achieve team and project goals

• Actively manage and develop a high performing team of scientists

• Organize early exploratory process experience to inform initial CMC development work

• Collaborate in early analytical development and planning of in-process sampling

• Develop and deliver scientific presentations, prepare clear and concise technical reports, participate or lead project teams

• Contributes to development of policies, SOPs, and department strategies

• Monitor and incorporate the latest developments in the antibody and gene therapy spaces for opportunities that will keep Neurocrine's franchises current and competitive

• Presents data and strategies at varying levels across the company

• Other duties as assigned

Requirements:

• BS/BA in Analytical Chemistry or related discipline and 10+ years of experience in pharmaceutical research or development OR

• MS/MA in Analytical Chemistry or related discipline and 8+ years of experience OR

• PhD in Analytical Chemistry or related discipline and 5+ years of relevant experience; may include postdoc experience

• Previous managerial / functional management experience also required

• Emerging as an internal thought leader with technical and/or business expertise

• Applies in-depth knowledge of own area of expertise to solve problems

• Applies in-depth understanding and may guide others on how own discipline integrates within the department as well as impact to other departments and understands contribution to Neurocrine's achievement of business objectives

• Expert knowledge and understanding of biologic process development and a thorough understanding of analytical techniques for biologics

• Excellent interpersonal skills with strong oral and written communication abilities

• Excellent laboratory and productivity skills

• Method development, validation, and transfer experience in process development a plus

• Expert knowledge of cross-functional understanding related to drug development

• Strong familiarity with ICH guidelines and regulatory requirements also a plus

• Emerging as an internal thought leader with technical and/or business expertise

• Applies in-depth knowledge of own area of expertise to solve problems

• Applies in-depth understanding and may guide others on how own discipline integrates within the department as well as impact to other departments and understands contribution to Neurocrine's achievement of business objectives

• Expert knowledge and understanding of biologic process development and a thorough understanding of analytical techniques for biologics

• Excellent interpersonal skills with strong oral and written communication abilities

• Excellent laboratory and productivity skills

• Method development, validation, and transfer experience in process development a plus

• Expert knowledge of cross-functional understanding related to drug development

• Strong familiarity with ICH guidelines and regulatory requirements also a plus

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Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, 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 $165,100.00-$238,900.00. 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.