Manager / Senior Manager, Drug Substance Contract Manufacturing Operations

SUMMARY:  The Manager / Senior Manager, Contract Drug Substance Manufacturing Operations manages the relationships, contracts, and activities of assigned commercial Drug Substance contract manufacturing organizations (CMOs) within the Neurocrine supply chain network. The role provides operational oversight of all cross-functional activities at the Drug Substance contract manufacturing sites, while ensuring that contractual commitments are honored. The role is accountable for the overall performance of assigned CMOs, including delivery, operational metrics, budget, and risk mitigation.

ESSENTIAL DUTIES AND RESPONSIBILITIES (include, but are not limited to):

  • Collaborates with internal cross-functional teams and CMOs to determine Drug Substance manufacturing requirements, identify and mitigate key risks, and ensure that manufacturing plans are executed as intended.
  • 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 stakeholder priorities across all Neurocrine commercial activities at Drug Substance CMOs.
  • 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 Person-in-Plant coverage at assigned Drug Substance CMOs for critical production activities as and when needed.
  • 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

QUALIFICATIONS:

Minimum Qualifications

  • Direct and proven CMO and Manufacturing Operations experience, including tech transfer, validation and commercial scale production of Drug Substances.
  • Demonstrated success in project planning, resource management, and collaboration with Development, Quality and development CMC.
  • Knowledge of how to negotiate and manage contracts, and establish and control budgets
  • Experience working in a cGMP-regulated environment, including knowledge of relevant US/EU regulatory and quality requirements, standards, and practices.
  • Strong knowledge of biotech/pharma manufacturing operations, and product and process development
  • Strong analytical and creative problem-solving skills.
  • Strong compliance orientation and attention to detail within a cGMP environment
  • Effective communicator at all levels; excellent written, oral and interpersonal communications and presentation skills.

Preferred Qualifications

  • Experience with manufacture of solid oral dosage products, with an emphasis on drug substance operations
  • Direct experience with the manufacture of marketed products.
  • Knowledge of risk management (e.g., FMEA) and process improvement tools (e.g., Lean / Six Sigma).

EDUCATION and/or EXPERIENCE:

  • Bachelor’s degree in Engineering, Science
  • Minimum of 5 Years of Drug Substance Manufacturing, Process Development or Engineering experience in the Pharmaceutical industry

OTHER WORKING CONDITIONS:

  • Requires ability to travel minimum of 25% in North America, Europe and possibly other countries.

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