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.
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)
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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
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
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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.