Director, Drug Product Manufacturing and Development

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
 
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

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

For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: 

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

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