Associate Director, Drug Product Development And Manufacturing

Associate Director, Drug Product Development and Manufacturing

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 Development and Manufacturing will support drug product manufacturing operations including manufacturing process development and optimization, clinical supply manufacturing and commercial preparedness. The individual will have experience with working and understanding drug product development throughout clinical development, particularly in aseptic fill finish and requires high level of collaboration both with internal teams and external partners. The Associate Director will report to Director, Drug Product Development and Manufacturing.

Responsibilities:

• Support the planning and implementation of sterile manufacturing process development, scale-up, technology transfer, and validation efforts in aseptic drug manufacturing at CDMO partners, ensuring strategic alignment and operational excellence.
• Collaborate with cross-functional teams, including drug substance, analytical development, quality assurance, and regulatory affairs to ensure seamless project progression.
• Support continuous improvement initiatives to enhance manufacturing efficiency, reduce costs, enable strategic redundancies, and improve product quality from both technical and strategic sourcing perspectives.
• Contribute to the selection, engagement, and management of CDMOs including initial vendor assessment and qualification, phase-appropriate technology transfers, process optimization, process validation, and manufacturing oversight.
• Draft technical reports and presentations to communicate results and progress to internal and external stakeholders.
• Support preparation of drug product modules in regulatory dossiers and collaborate with regulatory affairs to support regulatory submissions.

Required Qualifications:

• 10+ years' experience in the pharmaceutical/biotech industry with a proven track record of technical expertise and leadership in drug product formulation development and manufacturing. Experience with parenteral formulations and drug/device combinations is preferred.
• Demonstrated contribution on project and cross-functional teams.
• Working understanding and experience in drug product development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements in all phases of clinical drug product development and commercial launch.
• Extensive experience with management and oversight of manufacturing activities at CDMOs.
• Experience with drafting of regulatory submissions (IND, NDA, MAA, etc.).
• Strong problem-solving skills with strategic and sound technically driven decision-making ability.
• Effective written and verbal communication skills and interpersonal skills.
• Innovative team-player with high energy for our dynamic company environment.
• Travel: Up to 20% (domestic and international)

Education:

• Bachelors Degree in Pharmaceutical Sciences, Life Sciences, Engineering, or 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

At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.

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 (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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