What are the responsibilities and job description for the Director, Drug Product position at OSI?
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.
You can get further details about the nature of this opening, and what is expected from applicants, by reading the below.
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
Competencies
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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