kailera
Director, Drug Product Manufacturing and Development (Sterile)
At a Glance
- Location
- Massachusetts, United States
- Experience
- 10+ years
- Posted
- 2026-02-23T13:18:16-05:00
Key Requirements
Domain Knowledge
- Biotech
- Energy
- Engineering
- Insurance
- Manufacturing
- Pharmaceutical
- Regulatory
Benefits & Perks
offer comprehensive health coverage, flexible time off, paid holidays, and
Requirements
10+ years’ experience in the pharmaceutical/biotech industry with a proven track record of technical expertise and leadership in aseptic manufacture of sterile drug products
Extensive experience in the oversight of aseptic process development unit operations and equipment used for late-stage filling of vials, pre-filled syringes, and cartridges
Working knowledge and experience in aseptic drug product development and manufacturing with respect to cGMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements
Demonstrated contribution to project and cross-functional teams
Kailera Therapeutics, Inc.
Kailera Therapeutics, Inc.
Responsibilities
The candidate selected for Director, Drug Product Manufacturing and Development will oversee drug product manufacture from the clinical stage through the commercial stage for Kailera’s pipeline compounds.
This role will have high-visibility and will be responsible for providing technical oversight of late-stage process development activities, ensuring the necessary framework is in place for the manufacture of robust aseptic drug products at the commercial scale.
The selected individual will work closely with cross-functional teams across Kailera and external manufacturing partners to develop late-stage strategies for process scale-up, with a focus on commercial readiness.
Develop and design strategies for all aspects of late-stage process development, scale-up, optimization, and commercial readiness initiatives for aseptic drug products manufactured by external manufacturing partners
Implement initiatives to enhance manufacturing efficiency, ensure robustness, mitigate risks, reduce costs, and improve product quality through experimental design, providing technical expertise, and program leadership
Coordinate drug product campaign activities with leads from cross-functional groups across the Kailera organization to ensure seamless progression of timelines, updating the broader program team with regular updates