Senior Scientist - Analytical Development & QC (Onsite 3-4 days)

Kailera Therapeutics, Inc.; Waltham (MA); On-site; USD 143,000 - 175,000; Full time

Benefits offered by this job

Health coverage

401(k) match

Tuition reimbursement

Commuter benefits

Disability and life insurance

Annual bonus opportunities

Equity grants

Job summary

Kailera Therapeutics, Inc. in Waltham, MA seeks a Senior Scientist, Analytical Development and Quality Control to lead external partner-driven analytics for cGMP manufacturing and regulatory data support.

The role involves overseeing CDMOs, ensuring data integrity, method development and validation, and collaboration with Manufacturing and QA to enable compliant product development and release. The candidate will contribute to regulatory filings, maintain compliance with GMP, ICH, FDA and EMA

Qualifications

• PhD with ≥6 years, MS with ≥10 years, or BS with ≥12 years in analytical development and QC.
• Experience with peptides and/or small molecules in solid oral dosage forms.
• Experience managing outsourced activities with CDMOs.
• Strong analytical skills in HPLC, UPLC, MS, GC, dissolution, and spectroscopy.
• Knowledge of FDA/EMA and ICH guidelines for analytics.
• Effective written and verbal communication; works in fast-paced teams.

Responsibilities

• Participate in CDMO assessment and selection.
• Oversee analytical activities by CDMOs to ensure quality.
• Review data and ensure data integrity from CDMOs.
• Develop and implement analytical methods for drug substance/product.
• Oversee method validation aligned with regulatory requirements.
• Oversee stability programs for retest, shelf-life, and dating.
• Prepare data summaries/reports and review regulatory submissions.
• Ensure methods meet regulatory data integrity and traceability.
• Identify and investigate quality events (CAPAs, OOS).
• Collaborate with Manufacturing and QA to generate cGMP data.
• Provide technical guidance to internal teams and partners.
• Prepare and review protocols, reports, SOPs.

Skills

HPLC

UPLC

MS

GC

Dissolution

Spectroscopy

CDMO oversight

Analytical method development

Regulatory knowledge

Communication

Education

PhD in Analytical Chemistry or related

MS in Analytical Chemistry or related

BS in Analytical Chemistry or related

Job description

Kailera Therapeutics, Inc. in Waltham, MA seeks a Senior Scientist, Analytical Development and Quality Control to lead external partner-driven analytics for cGMP manufacturing and regulatory data support.

The role involves overseeing CDMOs, ensuring data integrity, method development and validation, and collaboration with Manufacturing and QA to enable compliant product development and release. The candidate will contribute to regulatory filings, maintain compliance with GMP, ICH, FDA and EMA