Director, Analytical Development and Quality Control

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, Analytical Development and Quality Control will provide strategic and technical leadership for the analytical development, qualification, validation, and lifecycle management of analytical methods, and overall analytical control strategy supporting the development and commercialization of sterile parenteral drug products, in support of Kailera’s pipeline. This role is responsible for leading all activities to enable successful regulatory submissions, approval, and product launch.

The successful candidate will bring progressive experience in pharmaceutical or biopharmaceutical analytical development, including demonstrated experience supporting an NDA for a parenteral drug product. The role requires a strong understanding of analytical chemistry, method development and validation, drug product characterization, stability programs, specifications, and regulatory CMC requirements, together with the ability to translate complex analytical data into sound technical and regulatory strategies.

The Director will work cross-functionally with other Technical Operations functions, Quality Control, Quality Assurance, Regulatory Affairs, Manufacturing, and external contract development and manufacturing organizations (CDMOs) and contract testing laboratories. This leader will establish analytical strategies, oversee external laboratory execution, ensure scientific and regulatory rigor, and drive analytical readiness to support clinical and regulatory milestones, NDA approval, and commercial supply.

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 analytical development, control strategy, and lifecycle management for sterile injectable/parenteral products from development through commercialization, including method development, validation, transfer, QC implementation, and commercial support.
• Define and execute analytical CMC strategies, regulatory submissions, and control frameworks, including NDA Module 3 content, analytical data packages, specifications, characterization, validation, stability, and commercial release requirements.
• Ensure scientifically sound, regulatory-compliant analytical programs by leading technical issue resolution, risk management, resource planning, agency interactions, and compliance w

[…]
ng development of peptide sterile injectable/combination drug products

• Experience supporting commercial products
• Knowledge of combination product testing and control strategy is a plus

Education

• A bachelor’s degree with 10+ years or an advanced degree with 8+ years of relevant experience
• Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field

Salary Range
$192,000 — $235,000 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.

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