Senior Scientist, Analytical Development

Apellis Uk Limited - Waltham, MA

Full-time - Senior

Waltham, MA

About the position

The Senior Scientist, Analytical Development will play a crucial role in supporting the analytical development and GMP activities for various pharmaceutical products, including small molecules and biological products. This position involves collaboration with internal teams and external partners to ensure the successful development and validation of analytical methods, as well as compliance with regulatory guidelines. The role requires flexibility and the ability to adapt to changing business needs while overseeing analytical activities and contributing to regulatory filings.

Responsibilities

• Support the development of Apellis pipeline programs by collaborating with internal teams and external sites.
• Manage and oversee analytical activities at CROs/CMOs/CTLs, ensuring deliverables meet program needs.
• Author and review analytical documents such as development reports, test methods, and validation protocols.
• Review analytical data packages generated at external sites.
• Select, characterize, and maintain reference standards for each program.
• Define and oversee stability studies to support retest period and shelf-life assignments.
• Author quality records to implement method changes and investigate non-conformances.
• Contribute to technical reports, including comparability protocols and risk assessments.
• Participate in internal and external project meetings, representing Analytical Development functions.

Requirements

• Minimum B.S. in analytical chemistry or related scientific disciplines; advanced degree (M.S. or Ph.D.) preferred.
• 10+ years of relevant industry experience, preferably in GMP roles for CMC.
• Theoretical understanding and hands-on experience in common analytical techniques (HPLC/UPLC, bioassay, MS, etc.).
• Extensive experience with analytical method development, validation, and transfer.
• Experience working with contract laboratories.
• Knowledge of FDA/EU/ICH regulations related to drug development.
• Proven ability to manage competing priorities and effective time management.
• Ability to work independently and collaboratively in a team environment.

Nice-to-haves

• Experience with forced degradation studies.
• Familiarity with regulatory filings such as INDs, IMPDs, NDAs/MAAs.

Benefits

• Health insurance with full premium coverage
• 401K with company match
• Paid time off (PTO)
• Long-term disability insurance
• Life insurance