Strategic Director, Analytical Development & QC

Kailera Therapeutics; United States; Hybrid; USD 192,000 - 235,000; Full time

Benefits offered by this job

Health coverage

Monthly wellness stipend

Generous 401(k) match

Tuition reimbursement

Commuter benefits

Disability and life insurance

Annual bonus opportunities

Equity grants

Job summary

Kailera Therapeutics is seeking an experienced Director of Analytical Development and Quality Control in Waltham, MA, with hybrid onsite/remote work options. Lead analytical strategy across sterile parenteral products, including method development, validation, transfer, and regulatory submissions.

The role requires 10+ years in pharma/biotech with deep analytical expertise (HPLC/UPLC, LC-MS, SE-HPLC) and strong regulatory, cross‑functional leadership, and CRO/CMO oversight.

Qualifications

• 10+ years in pharma/biotech with experience across development and commercial launch aligned to global CMC filings (IND/NDA/MAA).
• Expertise in analytical techniques HPLC/UPLC, LC–MS, SE‑HPLC, CCIT, device testing.
• Knowledge of cGMP, ICH guidelines, global regulatory requirements, and USP/EP/JP/CHP.
• Experience managing CROs/CMOs and external analytical development and QC activities.
• Demonstrated leadership with mentoring 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 NDA Module 3 content.
• Ensure scientifically sound, regulatory‑compliant analytical programs and issue resolution.
• Provide analytical leadership for product characterization, stability, microbiological strategies, and manufacturing support.
• Establish robust analytical methods through qualification, validation, and lifecycle management.
• Lead stability and specification strategies across product lifecycle and regulatory commitments.
• Integrate analytical, formulation, process, and manufacturing knowledge for tech transfer and oversight of external labs.

Skills

HPLC/UPLC

LC-MS

SE‑HPLC

CCIT

device testing

cGMP knowledge

Regulatory interactions

Education

Bachelor's degree +10+ years

Advanced degree +8+ years

Analytical/Physical/Pharmaceutical Sciences

Job description

Kailera Therapeutics is seeking an experienced Director of Analytical Development and Quality Control in Waltham, MA, with hybrid onsite/remote work options. Lead analytical strategy across sterile parenteral products, including method development, validation, transfer, and regulatory submissions.

The role requires 10+ years in pharma/biotech with deep analytical expertise (HPLC/UPLC, LC-MS, SE-HPLC) and strong regulatory, cross‑functional leadership, and CRO/CMO oversight.