Director, Drug Product Manufacturing and Development (Sterile)

What You’ll Do:

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.

 

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

 

Responsibilities:

• 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
• Provide technical expertise for process performance qualification campaigns, ensuring that materials, equipment, and process controls consistently produce high-quality sterile drug products
• As necessary, act as Kailera’s person-in-plant for process development, engineering, and cGMP activities critical to program success
• Support authoring, review, and approval of SOPs, batch records, change controls, deviations, OOS/OOT investigations, CAPAs, and campaign summary reports
• Author, review, and update CMC specific documents to support worldwide regulatory submissions (i.e., IND/IMPD, NDA and BLA)
• Provide scientific input and expertise to drug product activities related to life-cycle management initiatives for sterile drug products

 

Required Qualifications:

• 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
• Strong problem-solving skills with strategic and sound technically driven decision-making ability
• Effective interpersonal, written, and verbal communication skills
• Innovative team-player with high energy for Kailera’s fast-paced company environment

 

Preferred Qualifications:

• Prior experience in supporting the scale-up and commercialization of aseptic drug products, including process validation

 

Education:

• Bachelor of Science degree in Pharmaceutical Sciences, Life Sciences, Engineering, or related field. Advanced degree preferred