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Senior Scientist Analytical Development

1 month ago

Abingdon, Oxfordshire, United Kingdom Replimune, Inc. Full time
Job Summary:

Sr. Scientist Analytical Development is responsible for developing, optimizing, qualifying, and validating analytical methods based on new and existing methodologies to qualitatively and quantitatively evaluate both drug substance and drug product, from preclinical through late phase clinical development.

This position supports drug substance/drug product release, process development, and characterization and/or stability testing of Replimune's clinical material.

Key Responsibilities:
  • Manage the development, qualification and validation of analytical test methods and technology transfer in accordance with ICH and other regulatory guidances.
  • Support release and stability testing performed in house and at contract research organization (CRO), and directing good manufacturing practices (GMP) investigations including deviation root cause analyses, corrective action preventative action (CAPA), and out of specification (OOS).
  • Develop strategies for evaluating and implementing new technologies within Analytical Development.
  • Support process development, setting of specifications, and chemistry manufacturing and control (CMC) regulatory filings and responses.
  • Involved in daily workings of the group and actively participate in method troubleshooting and data analysis.
Qualifications:

A or B.S. degree in a relevant biological science is required. M.S., Ph.D. or other post-graduate degree in biochemistry or related science is preferred.

5-10 years industry experience, preferably in a cGMP Quality environment, with a thorough understanding of current regulatory requirements and practical experience of QC testing in support of cGMP operations.

Excellent verbal and written communication skills, good organizational skills, and computer processing literacy and experience in statistical analysis are required.