Associate Director, CMC Operations

Arena Pharmaceuticals, Inc   •  

San Diego, CA

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 39 days ago

This is an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas.

We are seeking an Associate Director of CMC Operations who will be responsible for providing chemistry, manufacturing and control (CMC) operational coordination and project management for Arena’s product development programs. A key objective of this position is to efficiently integrate and manage multiple interdisciplinary activities associated with analytical method, drug substance and drug product development and manufacturing and assist in developing risk-based strategies to ensure established timelines are met. This individual will work closely with internal departments, third party manufacturers and vendors to ensure timely completion of activities. Additional responsibilities may include but are not limited to: managing all CMC contracts and monthly/quarterly budget accruals, CMC technical reviews, and assisting in the review of the CMC sections of regulatory submissions.

What you’ll dive into

  • Ensure alignment of CMC operational plans with overall program development and corporate strategic plans
  • Facilitate timely execution of CMC plans through proactive management of operational interfaces between Tech Ops and other internal and external functions
  • Serve as primary point of contact between Arena and Arena’s contract service providers to ensure activities and deliverables are aligned to avoid disruptions within Supply Chain
  • Develop and manage metrics for evaluating selection and performance of contract service providers
  • As a member of the Tech Ops department, manage and update project/clinical plans and schedules to support development team objectives and clinical forecasts and demand
  • Identify risks to CMC timelines and/or budgets relating to CMC activities, inform senior management of potential issues, and provide solutions to mitigate risks
  • Integrate CMC timelines with corporate project management timelines and dashboards
  • Participate in periodic business and technical review meetings with contract service providers
  • Oversee/manage all CMC contracts including NDAs, MSAs, and work orders related to drug substance/drug product manufacturing, product development and analytical activities
  • Oversee the shipment of starting material, excipient, drug substance, and drug product inventories from point of inception to the desired final destination
  • Participate as Tech Ops representative during Finance accrual meetings

What we expect

  • BS/MS in chemistry, biochemistry, pharmaceutical sciences or closely related discipline and at least 10 years relevant experience with solid oral and sterile injectable drug product development and manufacturing
  • Working knowledge of current Good Manufacturing Practices (cGMP)
  • Demonstrated knowledge of small molecule drug development and process validation, CMOcontract management, and complex project management
  • Established project management skills and proven ability to effectively organize and prioritize tasks
  • Ability to adapt rapidly and change focus based on real-time results and findings
  • Exceptional interpersonal, written and verbal communication skills
  • Experience working with or at pharmaceutical CMOs is highly desirable

What you’ll get

  • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
  • Opportunities to learn and contribute creative solutions
  • Comprehensive health insurance
  • Matching 401k retirement plan
  • Paid time off and holidays
  • Company celebrations