Senior Scientist, Biologics Analytical Development

Proclinical is currently recruiting for a Senior Scientist of Biologics Analytical Development with a leading biotechnology company located in Gaithersburg, MD. As the Senior Scientist, you will make detailed observations, analyze data, interpret results, and exercise appropriate technical judgment in the design, execution, and interpretation of experiments.

Job Responsibilities:

• Develop, qualify and validate HPLC assays for purity of protein based biologics.
• Write SOP's, development report and assay qualification/validation report.
• Perform in-process testing to support process development activities.
• Perform tech transfer to Quality Control and other groups.
• Thoroughly analyze and review data and provide summary to manager.
• Troubleshoot assays.
• Maintain effective communication with other groups regarding sample testing and results.
• Manage resource to support Process Development and Discovery testing needs for product development.
• Apply new cutting-edge technologies to improve capability and throughput of in-process testing.
• Review in-process testing data and provide testing summary to Process Development group.
• Present scientific findings and in-process testing summary at internal meetings.
• Summarize release and stability testing to support IND/BLA filings.
• Write, edit, and review analytical sections of CMC regulatory filings

Skills and Requirements:

• PhD in biological science or biochemistry. Several years experience in pharmaceutical, biologics, and/or vaccine development.
• People management experience in leading a team of scientists.
• A thorough understanding of process-related impurity and contaminant testing methods.
• Ability to critically analyze data using statistical tools and to compile and review technical reports.
• Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements.
• Strong leadership skills and capable of working collaboratively and cross functionally.
• Understanding of FDA regulatory requirements and GMP practice associated with analytical analysis and documentation of vaccine products.
• Excellent organization and record keeping skills to timely record, track, and analyze sample testing and analytical data.
• Proficient in preparation and review of technical reports. Strong communication skills.

If you are having difficulty in applying or if you have any questions, please contact Max Robinson at (+1) 617-903-7746 or m.robinson@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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