Director, Product Development

Role Summary

Director, Product Development responsible for all aspects of the Chemistry, Manufacturing, and Controls (CMC) Drug Product Development including new drug product development projects (analytical, formulation, packaging, and process development), manufacture and supply of clinical supplies, and post-approval drug product support to ensure quality, safety, and efficacy of the drug products. Collaboration with Supply, Quality Assurance, and external CROs/CDMOs to meet timelines and milestones.

Responsibilities

• New drug product development projects ‚Äì Analytical, formulation, packaging, and process development using Quality By Design (QbD) and an outsourced development model; identify and mitigate potential quality issues early.
• New drug product development projects ‚Äì The manufacture and supply of clinical supplies.
• Post-Approval Drug Product Support ‚Äì Apply expertise in partnership with Supply and Quality Assurance to support existing commercial drug products, including investigations and closure of deviations and out-of-specifications, ongoing stability data review for compliance, and Continuous Process Verification (CPV) to verify that manufacturing processes meet CQAs and the control strategy.
• Ensure CMC perspective on Post-Approval Changes (PACs) with regulatory considerations; generate required supporting CMC information (e.g., comparability assessments, risk-based approaches) to support changes.
• Direct technical management of 3rd party CROs and CDMOs as part of outsourced CMC development; supervise and develop team members through training, guidance, and mentoring.
• Collaborate with other company personnel to meet timelines and milestones.

Qualifications

• Minimum: Bachelor‚Äôs degree; advanced degree a plus
• Field of Study: health sciences preferred
• Experience: 20 years in pharmaceutical development with emphasis in analytical, formulation, or process development; experience managing formulation development, analytical development, process development, and quality control groups; experience creating, managing, and reporting project plans and budgets; experience with Quality by Design (QbD).
• Travel: Domestic and international as needed (‚âà10%)

Skills

• Excellent organization, time management, and analytical skills
• High energy, self-motivation with experience in research, development, and post-marketing of globally regulated products
• Expertise in Analytical, Formulation, or Process Development with knowledge of cGMP and cGLP
• Proven ability to take products from research and development to market
• Ability to supervise and direct others to achieve milestones and timelines
• Experience with specialized analytical and manufacturing equipment; managing CROs and CDMOs
• Attention to detail; strong written and verbal communication; proficient in MS Office

Education

• Education: Bachelor‚Äôs degree; advanced degree preferred

Additional Requirements

• None beyond travel considerations noted above