Sr. Commercial Manufacturing API 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 )

At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.

 About the Role:

Oversees the relationships, contracts, and activities of commercial contract manufacturing organizations (CMOs) and/ or Contract Packaging organization (CPOs) within the Neurocrine supply chain network. Serves as the single point of contact for all aspects of the relationship with commercial CMOs and/ or CPOs. Leads technical discussions and technical review of manufacturing and/or packaging documentation. Develops and executes policies on operational oversight of all cross-functional activities at the contract manufacturing and or packaging sites, while ensuring that contractual commitments are honored. Accountable for the overall performance of assigned CMOs and/or CPOs, including delivery, operational metrics, budget, and risk mitigation. Oversees activities related to the timely planning, scheduling, manufacturing and/or packaging, 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 and or packing development operations. _

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

Leads and collaborates with internal cross-functional teams and CMOs to determine commercial manufacturing and/or packaging requirements, identify and mitigate key risks, and ensure that plans are executed as intended

Regularly interacts with senior management on matters concerning manufacturing and/or packaging operations

Manages stakeholder priorities across all Neurocrine commercial activities at CMOs and CPOs

Establishes and ensures adherence to schedules, work plans, and performance requirements

Ensures on-time and predictable delivery of products and projects at assigned CMOs and or CPOs

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 and or CPOs, ensuring cost, quality, metrics, delivery and program objectives are met

Manages operational risk at the CMOs and or CPOs

Provides management of and person-in-Plant coverage at assigned CMOs and or CPOs, for critical production activities as and when needed

Analyzes, identifies and champions process improvement, and solutions to complex issues at the CMOs and CPOs

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 and or CPOs

Partners with Neurocrine Quality Assurance to ensure CMOs and or CPOs are in compliance with all cGMP guidelines and Neurocrine SOP requirements

Supports the optimization of spend and resource allocation at the CMOs and or CPOs

Other duties as assigned

Requirements:

BS/BA degree in Engineering, Science or related field AND 8+ 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 6+ years of experience as noted above and previous managerial / functional management experience also required

Expertise with CMC and/or packaging contract manufacturers, including tech transfer, validation and commercial scale production

Extensive knowledge of CMC manufacturing and/or packaging processes for small molecules and gene therapy 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 $143,600.00-$196,000.00. 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.