Vice President of Manufacturing
Listed on 2026-09-01
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Manufacturing / Production
Regulatory Compliance Specialist
Vice President, Manufacturing Development | Massachusetts
A commercial-stage biotechnology company based in Massachusetts is seeking a Vice President of Manufacturing Development to join its Technical Operations leadership team.
With one commercial biologic already on the market and additional pipeline programs progressing through development, the company is entering its next phase of growth. Operating with the agility of a smaller biotech, this role offers the opportunity to shape manufacturing strategy across both the commercial product and future assets as they advance through development.
About the CompanyA commercial-stage biotechnology company based in Massachusetts is seeking a Vice President of Manufacturing Development to join its Technical Operations leadership team.
The RoleReporting to the Chief Technical Officer, the Vice President of Manufacturing Development will lead the Manufacturing Development function across the company's biologics portfolio. Working closely with Technical Operations, Quality, Regulatory Affairs, Supply Chain and external manufacturing partners, you will be responsible for driving manufacturing strategy, process optimisation and lifecycle management while ensuring a robust and reliable commercial supply.
This is a highly visible leadership role within a lean organisation, requiring someone who is equally comfortable setting strategy, building capability and remaining close to the technical detail when required.
Responsibilities- Lead the Manufacturing Development function across the commercial product and pipeline programs.
- Develop and execute manufacturing development strategy to support commercial supply and future product launches.
- Oversee technology transfer, process validation, process performance monitoring and lifecycle management activities.
- Drive manufacturing process optimisation, continuous improvement and operational excellence initiatives.
- Provide technical leadership across internal teams and external CDMO partners.
- Build, mentor and develop a high-performing Manufacturing Development organisation.
- Partner closely with Manufacturing, MSAT, Regulatory Affairs, Quality and Supply Chain to ensure cross-functional alignment.
- Support regulatory inspections, post-approval changes and global manufacturing readiness.
- Contribute to the broader Technical Operations strategy as a member of the leadership team
- PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, Biological Sciences or a related scientific discipline preferred.
- Significant leadership experience within Manufacturing Development, Technical Operations or Biologics Manufacturing.
- Proven experience supporting commercial biologic products and late-stage development programs.
- Experience managing external CDMO relationships and complex manufacturing networks.
- Demonstrated success building and leading high-performing technical organisations.
- Strong understanding of cGMP manufacturing and global regulatory expectations.
- Experience working within a fast-paced biotechnology environment, with the ability to balance strategic leadership and hands-on technical decision-making.
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