API Manufacturing Manager

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:

Oversees the relationships, contracts, and activities of API commercial contract manufacturing organizations (CMOs) within the Neurocrine supply chain network. Serves as the single point of contact for all aspects of the relationship with commercial CMOs. Leads technical discussions and technical review of manufacturing. Develops and executes policies on operational oversight of all cross-functional activities at the contract manufacturing, while ensuring that contractual commitments are honored. Accountable for the overall performance of assigned CMOs, including delivery, operational metrics, budget, and risk mitigation. Oversees activities related to the timely planning, scheduling, manufacturing, and quality control of production operations. Ensures the availability of relevant products in the supply chain, as scheduled, and the maintenance of inventory at minimum acceptable levels. When required, responsible for sourcing and supplying raw materials, utilities and outside services in support of commercial manufacturing.

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

• Leads and collaborates with internal cross-functional teams and CMOs to determine API commercial manufacturing, identify and mitigate key risks, and ensure that plans are executed as intended
• Regularly interacts with senior management on matters concerning manufacturing
• Manages stakeholder priorities across all Neurocrine commercial activities at CMOs
• Establishes and ensures adherence to schedules, work plans, and performance requirements
• Ensures on-time and predictable delivery of products and projects at assigned CMOs
• Reviews pre- and post-production documents (e.g., master and executed batch records, protocols, technical reports), and manages the approval process for the same
• Manages the operational activities (schedule, timelines, cost) of the CMOs, ensuring cost, quality, metrics, delivery and program objectives are met
• Manages operational risk at the CMOs
• Provides management of and person-in-Plant coverage at assigned CMOs for critical production activities as and when needed
• Analyzes, identifies and champions process improvement, and solutions to complex issues at the CMOs
• Develops, executes and owns the supplier management process including relevant scorecards, to ensure appropriate controls, oversight and monitoring are in place
• Supports the preparation and negotiation of RFQs, RFPs, Statements of Work (SOW), and Supply Agreements
• Supports validation activities for commercial products at assigned CMOs
• Partners with Neurocrine Quality Assurance to ensure CMOs are in compliance with all cGMP guidelines and Neurocrine SOP requirements
• Supports the optimization of spend and resource allocation at the CMOs
• Other duties as assigned

Requirements:

• BS/BA degree in Engineering, Science or related field and 6+ years of CMC Manufacturing, Process Development, Packaging Operations, Packaging Development or Engineering experience in the Pharmaceutical industry. Experience with manufacture or packaging of solid oral dosage products, with an emphasis on drug substance operations or packaging operations. Direct experience with the manufacture and/or packaging of marketed products. Experience working in a cGMP-regulated environment, including knowledge of relevant US / EU regulatory and quality requirements, standards and practices OR
• Master's degree in Engineering, Science or related field and 4+ years of experience as noted above
• Expertise with API CMC, including tech transfer, validation and commercial scale production
• Extensive knowledge of API CMC manufacturing for small and/or large molecules products
• Understanding of project planning, resource management, and collaboration with CMC Development, Quality and Regulatory functions
• Understanding of contracts, work orders, budgeting and cost control
• Knowledge of risk management (e.g., FMEA) and process improvement tools (e.g., Lean / Six Sigma, CPV)Knowledge of cGMP-regulated environment, including relevant US / EU regulatory and quality requirements, standards and practices
• Requires broad understanding of the processes, procedures and systems used to accomplish the team’s work and familiarity with the underlying concepts in other disciplines within the function
• Applies in-depth understanding of how own discipline integrates within the function and understands contribution to Neurocrine's achievement of business objectives
• Ability to influence and drive decision-making through fact-based analysis and rationale
• Ability to prioritize and multi-task in a fast-paced environment
• Strong sense of urgency, accuracy, and follow-through
• Analytical and creative problem-solving skills
• Excellent written, oral, interpersonal and presentation skills
• Demonstrated ability to work collaboratively across functions

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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 $119,700.00-$164,000.00. 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.