Director, Drug Product

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The Director, Drug Product will report to the Executive Director, CMC and will be responsible for managing drug product manufacturing for PepGen’s lead Enhanced Delivery Oligonucleotide (EDO) asset. In addition to actively supporting the preparation of regulatory filings, the Director will lead the technical collaboration with associated CMO/CRO organizations. The right candidate will possess an entrepreneurial approach to develop new, innovative ideas that can expand the impact and reach of the lead asset and inform future pipeline opportunities. The Director, Drug Product will demonstrate expert leadership in the completion of planned activities in accordance with agreed scope, timing, and budget. The ideal candidate will thrive in a fast-paced, biotech company.
Responsibilities

• Execute the DP strategy and oversee manufacturing of preclinical and clinical material
• Direct manufacturing process development, and sterile manufacturing activities on behalf of drug product development
• Represent drug product on CMC sub teams to present development strategies and manufacturing updates
• Perform the technical transfer of drug product process to CMOs and manage change controls, manufacturing batch record development, IPC, troubleshooting
• Lead scale-up and validation activities to support eventual commercial operations
• Develop strong and efficient working relationships with both internal and external partners
• Lead the outsourced aseptic fill finish manufacturing and release of clinical supplies and oversee routine manufacturing as a PepGen representative (PiP)
• Coordinate with clinical operations and clinical supply chain to ensure continuity of drug supply, adequate inventory and delivery
• Ensure cGMP compliance during production and testing including approval of batch documentation, management of OOS, deviation investigations and support cGMP audits
• Author and review drug product CMC regulatory submissions to support regulatory filings
• Review and approve drug product development protocols, MBRs, production records and testing results
  

Requirements

• Requires a Bachelor degree in engineering or related field with 10+ years of experience in developing sterile parenteral products or a Ph.D. or advanced degree in Pharmaceutical Sciences, Chemistry, Materials Science, or related field with 6+ years’ experience
• Skilled with parenterals - Specific experience with peptides and oligonucleotides (a plus)
• Experience with lyophilization processes and documented experience with sterile injectables including development of drugs for infusion
• Experience with full scope of clinical drug development (pre-clinical through commercialization) a plus
• Strong knowledge of QbD approaches to drug product development
• Documented experience working in a GMP environment
• Effective at implementing stage-appropriate change management and set realistic goals to ensure timely and successful completion
• Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective
• Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates and issues to senior leadership
• Available to travel if/when needed
  

Competencies

• Problem Solving: Strong use of logic defined methods to solve problems resulting in tangible, effective solutions
• Perspective: Ability to think globally and see ahead clearly to anticipate future challenges
• Priority Setting and Time Management: Efficiently and effectively use time to attend to a broader range of activities throughout the day putting more trivial tasks aside to focus on critical items
• Strategic Agility: Able to create competitive strategies and plans by anticipating future challenges and opportunities

Note: This is not a remote role. We like to work together and operate in a hybrid model in office Tues, Weds & Thurs each week.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Sales, General Business, and Education

• Industries

  Wireless Services, Telecommunications, and Communications Equipment Manufacturing

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