Director, Analytical Development & QC — Remote/Hybrid

Kailera Therapeutics, Inc.; Waltham (MA); Hybrid; USD 192,000 - 235,000; Full time

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Year-end shutdown

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability insurance

Life insurance

Bonus opportunities

Equity grants

Job summary

Kailera Therapeutics, Inc. is seeking a Director of Analytical Development and Quality Control to lead analytical development, qualification, validation, and lifecycle management for sterile parenteral products.

The role supports NDA submissions and regulatory readiness, coordinating with Regulatory Affairs, Manufacturing, QA, and external CDMOs. Ideal candidates have 10+ years in pharma/biotech, with strong cGMP knowledge and cross-functional leadership.

Qualifications

• 10+ years pharma/biotech experience with NDA/CMC filings.
• Experience with cGMP, ICH, regulatory guidelines.
• Proven CRO/CMO management and external analytics.
• Strong leadership and mentoring abilities.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Lead analytical development, control strategy, and lifecycle management for sterile injectable/parenteral products from development through commercialization.
• Define and execute analytical CMC strategies, regulatory submissions, and control frameworks.
• Ensure scientifically sound, regulatory-compliant analytical programs with issue resolution, risk management and agency interactions.
• Provide analytical leadership for product characterization, stability, microbiological strategies, QA manufacturing support, and investigations.
• Establish and maintain robust analytical methods through qualification, validation, and lifecycle management.
• Lead stability and specification strategies across product lifecycle for shelf life, storage, and regulatory commitments.
• Integrate analytical, formulation, process, and manufacturing knowledge to support technology transfer and oversight of external labs.

Skills

Leadership

Communication

Project management

Cross-functional collaboration

Regulatory strategy

Education

Bachelor’s degree in Chemistry

Advanced degree in Chemistry/Pharmaceutical Sciences

Job description

Kailera Therapeutics, Inc. is seeking a Director of Analytical Development and Quality Control to lead analytical development, qualification, validation, and lifecycle management for sterile parenteral products.

The role supports NDA submissions and regulatory readiness, coordinating with Regulatory Affairs, Manufacturing, QA, and external CDMOs. Ideal candidates have 10+ years in pharma/biotech, with strong cGMP knowledge and cross-functional leadership.