Associate Director, Drug Product

Associate Director, Drug Product

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 Associate Director, Drug Product will support drug product activities with external partners including manufacturing process development and optimization, clinical supply manufacture and commercial preparedness with a focus on oral solid dosage forms. The individual will have a working knowledge of drug product development throughout clinical development.

Responsibilities :

Contribute to the selection, engagement, and management of CDMO's, including assessment of capabilities, drafting requests for proposals, and providing recommendations based on selection criteria

Coordinate technology transfer, formulation and process development, optimization, scale-up and manufacturing of clinical supplies, acting as Kailera's person-in-plant for activities critical to program success

Collaborate closely with internal cross-functional teams, including Drug Substance, Analytical Development, Supply Chain, Clinical, Quality Assurance, and Regulatory Affairs to ensure seamless progression of projects

Review master batch records and executed batch records to ensure product quality

Manage cGMP change controls and manufacturing deviations as necessary, working closely with Kailera's quality group

Lead initiatives to enhance manufacturing efficiency, reduce costs and improve product quality through experimental design with a focus on commercial preparedness

Author, review, and update CMC specific documents to support worldwide regulatory submissions (i.e., IND, IMPD and NDA)

Required Qualifications :

10+ years of experience in the pharmaceutical industry with a proven track record of technical expertise in unit operations common to solid oral dosage form (e.g., dry granulation, compression and film-coating)

Extensive experience with management and oversight of activities at CDMO's

Strong troubleshooting skills with the ability to quickly provide input in a fast-paced environment

Strong working knowledge of Excel, Word, PowerPoint

Experience drafting CMC documents for regulatory filings

Experience using quality systems such as Veeva to author and approve documents

Excellent verbal, written and interpersonal skills

Innovative team-player capable of working cross-functionally to achieve program goals

Ability to travel up to 20% (domestic and international)

Preferred Qualifications :

Experience in the GLP-1 space

Education :

Bachelors Degree in Engineering, Pharmaceutical Sciences, Life Sciences or closely related field

Benefits of Working at Kailera :

In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families.

Comprehensive health benefits and tax-advantaged savings accounts

Flexible time off, 13 paid holidays, and a companywide year-end shutdown

Monthly wellness stipend

Generous 401(k) match

Disability and life insurance

Salary Range

$160,000 - $200,000 USD