Director, Drug Substance Commercial Manufacturing

The posting, as Kailera Therapeutics, Inc. wrote it

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 Director, Drug Substance Commercial Manufacturing will own Drug Substance (DS) technology transfer, Manufacturing Science and Technology (MSAT), manufacturing oversight, and Operational Excellence (OpEx) for assigned CDMO sites in Kailera’s CDMO network. Reporting to the Vice President, Commercial Manufacturing, this leader is the sponsor-side technical and operational owner of the DS process at those sites, from transfer-in and validation through launch, routine commercial supply, continued process verification (CPV), and lifecycle management. Where an assigned CDMO is also developing new processes for Kailera, the role provides sponsor oversight of that work.

The role leads the MSAT and manufacturing oversight team and the day-to-day relationship with each CDMO. This role works closely with CMC Development and Analytical, who retain decisions on process development and on analytical methods and specifications. This person ensures the agreed processes and methods are implemented at the CDMO exactly as approved, with no unapproved changes. They coordinate with peer DS leaders to keep process knowledge, controls, and analytical performance consistent across the network, and partners with Quality, Regulatory CMC, Drug product, Supply Chain, and the Project Management Office (PMO).

Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month).

Responsibilities

• Lead DS transfer to assigned CDMOs: process knowledge packages, equipment and facility fit assessments, scale-up, engineering batches, and transfer acceptance criteria. Translate network DS strategy into an execution plan with milestones, resources, and risks through PPQ, registration, and launch
• Lead drug substance (DS) technology transfer, process validation, commercialization, and lifecycle management across CDMO partners, ensuring successful scale-up, PPQ execution, regulatory approval, launch readiness, and continuous supply
• Serve as the technical owner of commercial peptide DS processes, providing oversight of manufacturing operations, process performance, yield, quality, robustness, control strategies, and continuous improvement initiatives
• Drive process monitoring, comparability assessments, investigations, change control, CAPAs, and continued process verification (CPV), partnerin

[…]
preparative chromatography, commercial isolation and drying

• Experience with design of experiments, statistical process evaluation, and CPV
• Lean, Six Sigma, or equivalent continuous improvement training or certification

Education

• Bachelor’s degree in chemistry, chemical engineering, pharmaceutical sciences, biotechnology, or a related field required. An advanced degree (M.S., Ph.D., or equivalent) is preferred

Salary Range
$196,000 — $240,000 USD

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

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