Senior Scientist, Analytical Development and Quality Control

Kailera Therapeutics•Waltham, MA

6d•Hybrid

About The Position

The Senior Scientist, Analytical Development and Quality Control will support analytical development and quality control activities performed by our external partners for cGMP manufacturing, quality release, and stability. The Senior Scientist will work directly with technical counterparts at vendor sites to implement the required product controls and ensure the integrity of data generated by our external partners. This role will also provide critical support for regulatory filings and ensure compliance with global regulatory standards.

Requirements

Ph.D. with a minimum of 6 years, MS with a minimum of 10 years, or BS with a minimum of 12 years of experience in analytical development and quality control within the pharmaceutical or biotech industry
Proven experience with peptides and/or small molecules in solid oral dosage forms
Experience managing outsourced activities with CDMOs
Strong expertise in analytical techniques such as HPLC, UPLC, MS, GC, dissolution, and spectroscopic methods
Knowledge of regulatory requirements (FDA, EMA) and ICH guidelines related to analytical development
Proven effective communication and interpersonal skills
Ability to work effectively in a fast-paced, collaborative environment

Nice To Haves

Experience with development of discriminatory dissolution methods to support late-phase process changes, scale-up, and comparability for solid oral dosage forms
Experience with developing small molecule drug substance impurity control strategies, including qualification, fate-and-purge, and specification setting

Responsibilities

Participate in the assessment and selection of Contract Development and Manufacturing Organizations (CDMOs)
Oversee analytical activities conducted by these CDMOs to ensure external partners fulfill technical needs and quality standards
Perform detailed review and provide data integrity oversight of data generated at CDMOs
Ensure appropriate methods are developed and implemented for drug substance and drug product based on identified critical quality attributes
Provide oversight of phase-appropriate method validation activities in alignment with current regulatory requirements
Oversee stability programs to support product retest, shelf-life, and expiration dating
Contribute to the preparation of data summaries and reports, and data review of regulatory submissions (INDs, NDAs, IMPDs)
Ensure analytical methods and data meet regulatory requirements, generate data to justify specification limits, and assess trends in stability data
Ensure all analytical activities comply with GMP, ICH guidelines, and other relevant regulations
Participate in internal and external investigations of quality events (e.g., deviations, CAPAs, OOS, etc.)
Work closely with Manufacturing and Quality Assurance teams to generate cGMP compliant data during product development and manufacturing
Provide technical guidance and support to internal teams and external partners
Oversee the preparation and review of technical documents, including protocols, reports, and SOPs
Ensure data integrity and traceability in all analytical documentation