Senior Scientist - Contract - Gaithersburg, MD
Proclinical is seeking an experienced Scientist to join an Analytical Development team as a Senior Scientist.
Primary Responsibilities:
The successful candidate will lead a dynamic group of scientists, focusing on the development and application of various methods for the characterization of protein or vaccine products. This role is pivotal in the development, qualification, and validation of molecular separation assays for testing vaccine products. A good understanding of FDA and ICH guidelines and practical knowledge with assay validation and cGMP will be advantageous.
Skills & Requirements:
- Experience in leading a team.
- Strong expertise in the development of separation methods for recombinant proteins.
- Team management skills to lead a team of scientists and develop and motivate scientists to achieve results.
- Demonstrated leadership skills and ability to work collaboratively and cross-functionally.
- Ability to critically analyze data using statistical tools and to compile and review technical reports.
- Ability to define priorities and process to get things done.
- Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) is preferred.
- Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements.
- Strong communication, presentation, and writing skills.
- MS or PhD in analytical science, chemistry, biochemistry, or related field.
The Senior Scientist's responsibilities will be:
- Guide a team of professionals in developing, qualifying and validating separation methods for characterizing recombinant protein vaccine products.
- Participate in cross-functional workflows and provide scientific guidance to teams.
- Apply new technologies to improve throughput for in-process testing and enhance product characterization capabilities.
- Perform method transfers to QC and other groups and external partners.
- Analyze results and methods, solve analytical problems, troubleshoot assays, and meet regulatory expectations for analytics.
- Prepare and review standard operating procedures, method development reports, qualification/validation protocols and reports, and scientific journal publications and presentations.
- Write, edit, and review analytical sections of CMC regulatory filings.
- Maintain effective communication with process development, formulation development, QC, QA, research, and clinical immunology.
- Present scientific findings at internal and external meetings.
- Manage a team of 3-5 scientists.
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at (+1) 267-846-2026 or j.cerchio@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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