Associate Director, CMC Operations

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

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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