Associate Director, CMC Operations

Kailera Therapeutics is seeking an Associate Director, CMC Operations to manage the flawless execution of CMC activities, including financial management, alliance management with CDMO partners, technical development, technology transfers, manufacturing, and regulatory submissions. This role supports cross-functional CMC sub-teams for multiple development projects, focusing on advancing novel therapies for obesity and related conditions within an entrepreneurial and team-oriented culture.

Must Have

• Manage execution of CMC activities for regulatory submissions and product approvals.
• Support Tech Ops strategies by leading cross-functional CMC sub-teams.
• Collaborate with Tech Ops, Quality, Regulatory, and Finance for efficient practices.
• Proactively communicate key issues and critical topics to management.
• Ensure quality, quantity, and timelines in all assigned projects.
• Update on project target dates, contribute to budget forecasts and expense tracking.
• 10+ years in pharmaceutical drug development, clinical/commercial manufacturing.
• Track record supporting multiple projects simultaneously.
• Excellent communication and presentation skills.
• Proficiency in Smartsheet software.
• Proven creativity, problem-solving, and productivity.
• Successful experience in interdisciplinary and cross-cultural teams.

Perks & Benefits

• 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 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:

Reporting to the Senior Director, CMC Operations, the Associate Director, CMC Operations will manage the flawless execution of Kailera’s CMC activities, spanning departmental financial management, alliance management with CDMO partners, technical development work, technology transfers, manufacturing, and preparation of regulatory submissions. In collaboration with CMC core team representatives, the individual will support cross-functional CMC sub-teams to manage all technical activities for Kailera’s multiple development projects. The Associate Director will also establish preparation and monitoring of departmental budgets.

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

Responsibilities:

• Support execution of CMC-related projects, culminating in the successful preparation of regulatory submissions and product approvals
• Actively support Tech Ops strategies and goals by participating in and/or leading cross-functional CMC sub-teams
• Work closely and collaboratively with Tech Ops, Quality, Regulatory, and Finance colleagues to maintain highly efficient practices for pharmaceutical product development and budget management activities
• Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team members
• Ensure quality, quantity, and timelines in all assigned projects
• Update team members on project target dates and priorities. Proactively contributes to budget forecasts and tracking expenses

Required Qualifications:

• 10+ years of experience in pharmaceutical drug development, clinical and/or commercial manufacturing familiarity, and track record of success supporting multiple projects or programs simultaneously
• Excellent communication/presentation skills and proficiency in Smartsheet software
• Proven track record of creativity, problem solving, and productivity, particularly when no or minimal precedent is in place
• Demonstrated successful experience with working in interdisciplinary and cross-cultural teams

Education:

• Bachelor’s degree in a scientific discipline preferred

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.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

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