Drug Product Manufacturing Manager

Neurocrine Biosciences • San Diego, CA

6d

About The Position

Oversees the relationships, contracts, and activities of commercial drug product 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 commercial 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.

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 drug product CMC, including tech transfer, validation and commercial scale production
• Extensive knowledge of drug product 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

Responsibilities

• Leads and collaborates with internal cross-functional teams and CMOs to determine drug product 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

Benefits

• annual bonus with a target of 30% of the earned base salary
• eligibility to participate in our equity based long term incentive program
• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Manager