Director, Drug Product

6 days ago

boston, United States PepGen Full time

The Director will be managing drug product manufacturing for PepGen’s Enhanced Delivery Oligonucleotides (EDOs) pipeline. In addition to actively supporting the preparation of regulatory filings, the Director will lead the technical collaboration and integrated planning with PepGen’s internal CMC team and associated CMO/CRO organizations. The right candidate will possess an entrepreneurial approach to develop new, innovative ideas that will drive growth within the drug product organization. The Director 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, rapidly growing biotech company.


Responsibilities

  • Execute the DP strategy and oversee manufacturing of preclinical and clinical material
  • Lead CMC sub-teams for early development project (Phase 1/2), representing the CMC development team on program teams
  • Direct manufacturing process development, and sterile manufacturing activities on behalf of drug product development
  • 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)
  • 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
  • Proven leadership skills, including demonstrated ability to lead a cross-functional team, and to influence at all levels of the organization
  • Effective at planning and 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 the executive 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


About PepGen:

PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates that target the root cause of serious diseases. For more information, visit www.pepgen.com or follow PepGen on Twitter and LinkedIn.


EEO Statement

PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.


Recruitment & Staffing Agencies: PepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all of our recruiting needs. Thank you.

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