Associate Director, CMC Operations (Fully Remote)

Kailera Therapeutics; United States; Remote; USD 180,000 - 230,000; Full time

Benefits offered by this job

Health coverage

Flexible PTO

Paid holidays

Year-end shutdown

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability insurance

Life insurance

Annual bonus

Equity grants

Job summary

Kailera Therapeutics is a biopharmaceutical company focused on obesity and related conditions, nurturing an entrepreneurial, team-oriented culture and inclusive workplace. We seek a senior CMC program manager to drive planning and execution across CMC workstreams and coordinate with CDMOs.

In this role, you will own integrated timelines in Smartsheet, oversee cross-functional decision-making, and contribute to budget forecasting.

Qualifications

• 10+ years in pharmaceutical drug development, incl. 5+ years in CMC PM.
• Advanced Smartsheet proficiency; CDMO partnerships experience in manufacturing campaigns.
• Strong communication, presentation, and budget management skills.
• Health coverage, flexible PTO, paid holidays, and year-end shutdown.
• Monthly wellness stipend, 401(k) match, tuition reimbursement, and commuter benefits.
• Disability and life insurance, yearly bonus opportunities, and equity grants.

Responsibilities

• Drive planning and execution of CMC workstreams, from technical development through regulatory submission.
• Build and maintain integrated timelines in Smartsheet, facilitating cross-functional team decisions and risk management.
• Coordinate CDMO activities and support departmental budget planning and forecasting.

Skills

CMC project management

Smartsheet

CDMO partnerships

Budget management

Communication

Presentation

Job description

• Drive planning and execution of CMC workstreams, from technical development through regulatory submission.
• Build and maintain integrated timelines in Smartsheet, facilitating cross-functional team decisions and risk management.
• Coordinate CDMO activities and support departmental budget planning and forecasting.

Qualifications:

• 10+ years in pharmaceutical drug development, including 5+ years in CMC project management.
• Advanced Smartsheet proficiency and experience with CDMO partnerships and manufacturing campaigns.
• Strong communication, presentation, and budget management skills.
• Comprehensive health coverage, flexible PTO, paid holidays, and year-end shutdown.
• Monthly wellness stipend, 401(k) match, tuition reimbursement, and commuter benefits.
• Disability and life insurance, annual bonus opportunities, and equity grants.

Kailera Therapeutics

Kailera is a biopharmaceutical company developing novel therapies for obesity and related conditions. It fosters an entrepreneurial, team-oriented culture and is committed to building an inclusive workplace.