Senior Scientist, Analytical Dev & QC for CDMOs

Regulatory Jobs; Waltham (MA); On-site; USD 143,000 - 175,000; Full time

Benefits offered by this job

Health coverage

401(k) match

Tuition reimbursement

Commute benefits

Annual bonus

Job summary

Kailera Therapeutics is seeking a Senior Scientist, Analytical Development and Quality Control, to oversee analytical work performed by external partners and ensure data integrity for regulatory filings. The role requires collaboration with CDMOs and internal teams to maintain GMP standards in drug development.

The position is based in Waltham, MA, onsite 3-4 days per week, with a focus on analytical method development, validation, and stability, supporting cGMP manufacturing and regulatory

Qualifications

• PhD/MS/BS with extensive experience in analytical development and QC in pharma/biotech.
• Experience with peptides and/or small molecules in solid oral dosage forms.
• Experience managing outsourced activities with CDMOs.
• Strong expertise in analytical techniques (HPLC/UPLC/MS/GC) and regulatory knowledge.

Responsibilities

• Oversee analytical activities conducted by CDMOs to meet quality standards.
• Ensure data integrity and regulatory compliance for data generated at CDMOs.
• Contribute to regulatory submissions (INDs/NDAs/IMPDs) with data summaries and reports.
• Provide technical guidance to internal teams and external partners.
• Ensure methods for drug substance and product meet critical quality attributes.

Skills

HPLC

UPLC

MS

GMP

Regulatory knowledge

Communication

Team collaboration

Education

PhD in Analytical Chemistry

MS in Chemistry

BS in Chemistry

Tools

HPLC

UPLC

MS

GC

Dissolution

Spectroscopy

Job description

Kailera Therapeutics is seeking a Senior Scientist, Analytical Development and Quality Control, to oversee analytical work performed by external partners and ensure data integrity for regulatory filings. The role requires collaboration with CDMOs and internal teams to maintain GMP standards in drug development.

The position is based in Waltham, MA, onsite 3-4 days per week, with a focus on analytical method development, validation, and stability, supporting cGMP manufacturing and regulatory