Sr. Scientist/Scientist, Analytical Development

Sr. Scientist/Scientist, Analytical Development

Vacancy expired!

Sr. Scientist/Scientist, Analytical Development
Richmond, CASummary
This position of Sr. Scientist, Analytical Development will lead the development, optimization, and transfer of analytical methods to support our process development and quality control. The successful candidate will be experienced with development and validation of physiochemical assays and will drive the phase-appropriate method development, optimization, qualification and tech transfer. The candidate will be expected to design and perform experiments and, organize, document, analyze and interpret results with a high degree of independence and leveraging sound scientific principles.Key Responsibilities

• Establish and oversee a high performing team capable of supporting analytical development activities with an emphasis on physicochemical, biological, and compendial methods.
• Evaluate and implement new technologies within the Analytical Development group, with a particular emphasis on separation techniques (HPLC/UPLC and CE), and binding based assays
• Write/review SOPs, test method protocols, assay development and qualification plans/reports
• Write/review analytical sections of IND/IMPD filings
• Provide mentorship and training of junior level scientists in the laboratory
• Coordinate activities of outside resources such as consultants and vendors
• Represent analytical development group in project meeting

• PhD in Biochemistry, Analytical Chemistry or a related discipline with a minimum of 2 years of relevant industry work experience or a Master's or Bachelor's degree with a minimum of 6 years of relevant industry experience
• Proven expertise/experience in developing and qualifying/validating analytical methods to support product development and QC batch release, preferably for biologic products
• Strong background in physicochemical methods (UPLC/HPLC, CE) and bioassays (ELISA, qPCR), excellent instrument and method troubleshooting skills, as well as knowledge of various data analysis approaches
• Understanding of regulatory requirements for early-stage development of biologics including compendial requirements as well as requirements associated with the assessment of critical quality attributes, control strategies, stability, and comparability as outlined in ICH Guidelines and FDA guidance documents
• General understanding of statistical principles supporting method performance and robustness assessments as well as Design of Experiment approaches used for method development/optimization
• Excellent communication skills
• Experience managing people in project-based or functional teams
• Working experience in biologic formulation development is a plus