Associate Director, Drug Product Manufacturing and Development (Oral)

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.

Required location: San Diego, CA (hub-based, onsite 3-4 days per week).

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

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.

 #LI-Hybrid