Kailera Therapeutics, Inc.
Associate Director, Manufacturing and Development
Kailera Therapeutics, Inc., San Diego, California, United States, 92189
Associate Director, 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 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 (onsite or hybrid 2-3 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
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
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:
Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender, gender identity or expression, 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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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 (onsite or hybrid 2-3 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
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
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:
Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender, gender identity or expression, 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.
#J-18808-Ljbffr