Senior Scientist, Analytical Development & QC (CDMO)

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

Benefits offered by this job

Health coverage

401(k) match

Tuition reimbursement

Bonuses & equity grants

Wellness stipend

Job summary

Kailera Therapeutics in Waltham, MA is seeking a Senior Scientist to lead analytical development and quality control efforts, collaborating with external CDMOs to ensure data integrity and regulatory readiness. The role focuses on method development, validation, and support for IND/NDA submissions.

The position expects significant expertise in HPLC/UPLC and MS, with a strong regulatory understanding and excellent cross-functional communication.

Qualifications

• PhD/MS/BS with substantial experience in analytical development and quality control.
• Peptides and/or small molecules in solid oral dosage forms.
• Experience managing outsourced activities with CDMOs.
• Strong expertise in HPLC, UPLC, MS, GC, dissolution, and spectroscopic methods.
• Knowledge of FDA/EMA regulations and ICH guidelines for analytical development.
• Proven communication and interpersonal skills.
• Ability to work in a fast-paced, collaborative environment.

Responsibilities

• Oversee analytical activities conducted by CDMOs to meet technical needs and quality standards.
• Review data for integrity and ensure regulatory compliance.
• Develop and implement analytical methods for drug substance and product.
• Oversee method validation and stability programs.
• Support regulatory submissions (INDs, NDAs, IMPDs) with data summaries.
• Ensure GMP compliance and traceability in documentation.
• Guide internal teams and external partners on analytical activities.

Skills

Analytical development

Quality control

CDMO management

Regulatory filings

Data integrity

Communication skills

Collaborative work

Education

PhD in Analytical Chemistry / Pharmaceutical Sciences

MS in Analytical Chemistry / Pharmaceutical Sciences

BS in Chemistry / related field with significant experience

Tools

HPLC

UPLC

MS

GC

Dissolution testing

Spectroscopic methods

Job description

Kailera Therapeutics in Waltham, MA is seeking a Senior Scientist to lead analytical development and quality control efforts, collaborating with external CDMOs to ensure data integrity and regulatory readiness. The role focuses on method development, validation, and support for IND/NDA submissions.

The position expects significant expertise in HPLC/UPLC and MS, with a strong regulatory understanding and excellent cross-functional communication.