What You’ll Do:

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.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

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

Required Qualifications:

• 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

Preferred Qualifications:

• 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

Education:

• PhD. or MS degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related field, or a BS degree with a commensurate amount of directly applicable industry experience