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Job Title: Head of Biologics Development and Technology - Drug Substance
Location: Remote
Our client, a disruptive generic pharmaceutical manufacturer, is committed to ensuring a stable supply of affordable essential medications. We are addressing some of the most pressing needs in healthcare by developing and manufacturing affordable biosimilar drugs, including insulin. Join us in our innovative journey to make healthcare accessible for all.
Role Summary: Lead end-to-end development of recombinant Drug Substances for biosimilar programs, manage development partners and CDMOs, ensure compliance with cGMP and Quality by Design principles, and hold lifecycle accountability from development through post-approval.
Key Responsibilities:
Why Join Us: This is a unique opportunity to lead in a high-impact role within a novel non-profit manufacturing startup, directly contributing to the affordability and accessibility of life-saving medications.
- 401(k)
- 401(k) matching
- Bonus based on performance
- Competitive salary
- Health insurance
- Paid time off
Job Title: Head of Biologics Development and Technology - Drug Substance
Location: Remote
Our client, a disruptive generic pharmaceutical manufacturer, is committed to ensuring a stable supply of affordable essential medications. We are addressing some of the most pressing needs in healthcare by developing and manufacturing affordable biosimilar drugs, including insulin. Join us in our innovative journey to make healthcare accessible for all.
Role Summary: Lead end-to-end development of recombinant Drug Substances for biosimilar programs, manage development partners and CDMOs, ensure compliance with cGMP and Quality by Design principles, and hold lifecycle accountability from development through post-approval.
Key Responsibilities:
- Serve as the technical expert for Drug Substance process development.
- Oversee process Development and manufacturing to meet US FDA standards.
- Manage CDMO selection and technical transfer activities.
- 10+ years in biologics process development.
- Expertise in BLA support and process scale-up/technical transfers.
- Strong communication and the ability to work remotely with up to 35% travel.
Why Join Us: This is a unique opportunity to lead in a high-impact role within a novel non-profit manufacturing startup, directly contributing to the affordability and accessibility of life-saving medications.
Flexible work from home options available.
