Senior Scientist, Analytical Development & QC

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

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Life insurance

Equity grants

Annual bonus opportunities

Job summary

Kailera Therapeutics seeks a Senior Scientist, Analytical Development and Quality Control to work with CDMOs for cGMP manufacturing and data integrity.

The role provides regulatory filings support, method validation, and stability program leadership. Onsite work at the Waltham hub 3–4 days/week; PhD/MS/BS with extensive analytics experience required. Competitive salary and comprehensive benefits offered.

Qualifications

• PhD/MS/BS with significant experience in analytical development and QC in pharma/biotech.
• Experience with peptides or small molecules in solid oral dosage forms.
• Experience managing outsourced activities with CDMOs.
• Knowledge of FDA/EMA and ICH guidelines related to analytics.

Responsibilities

• Oversee CDMOs' analytical activities to ensure quality standards.
• Review data integrity and regulatory submissions (INDs/NDAs/IMPDs).
• Ensure GMP, ICH guidelines compliance across analytics.
• Provide technical guidance to internal teams and partners.
• Oversee method validation and stability programs.
• Support data generation for regulatory filings.

Skills

Analytical development

Quality control

CDMO management

HPLC

UPLC

MS

Regulatory knowledge

Communication

Team collaboration

Education

PhD in Analytical Chemistry

MS in Analytical Chemistry

BS in Chemistry

Tools

HPLC

UPLC

MS

GC

Dissolution

Job description

Kailera Therapeutics seeks a Senior Scientist, Analytical Development and Quality Control to work with CDMOs for cGMP manufacturing and data integrity.

The role provides regulatory filings support, method validation, and stability program leadership. Onsite work at the Waltham hub 3–4 days/week; PhD/MS/BS with extensive analytics experience required. Competitive salary and comprehensive benefits offered.