- Assay Development: Proficient in developing assays and understanding GMP requirements to transition assays into a validated state.
- Method Validation: Clear grasp of the difference between a qualified method and a validated method.
- Analytical Techniques: Must be adept at executing a range of analytical techniques, including UV methods, SDS-PAGE, Liquid Chromatography (LC), Capillary Electrophoresis (CE), ELISA and Western Blotting. Proficiency in all the above techniques is essential.
- Cell-Based Potency Assays: While not a mandatory skill, experience with cell-based potency assays is advantageous and can substitute for ELISA expertise.
- Characterization Techniques: Experience with common characterization techniques is required, such as: AUC, LC/MS, MFI, DLS, CD. A strong emphasis on AUC and LC experience.
- Regulatory Documentation: Involvement in Module 3 characterizations for Biologics License Application (BLA) filings is part of the role. Experience in authoring or reviewing data, especially for AUC, is preferred.
- Computational Skills: A working knowledge of programming languages such as R or Python is required.
- Execute technical analytical methodologies to support development and validation of test methods.
- Author and review analytical methods, protocols, reports, and other technical documents, including instrument qualification and change control.
- Operation, maintenance, and installation of sophisticated analytical instrumentation and associated computer control systems.
- Be part of a team that establishes, maintains, and improves technical operations and project outcomes in the Analytical Development area.
- Provide support for laboratory operations – inventory tracking, reagent preparation, sample management, and documentation review.
- Execute analytical and biological methods ensuring compliance with applicable ICH guidelines and global regulations.
- Ensure adherence to GMPs, GLPs, GCPs and GDPs where required.
- Extensive experience performing basic analytical assay techniques: absorbance assays, SDS-PAGE, chromatography, CE-SDS, ELISA, western blot, cell-based potency assay.
- Extensive experience in common characterization techniques such as AUC, LC/MS, MFI, DLS, and CD.
- Extensive experience developing/authoring protocols, methods, and SOPs.
- Be able to communicate technically and strategically across technical and operational activities and work collaboratively to ensure successful execution.
- Strong written and verbal communication skills.
- Working knowledge of statistics; R, Python, or other statistical tools.
- Ability to work on multiple projects simultaneously, demonstrating organizational and problem-solving skills.
- Self-motivated, proactive and driven individual with an interest in experimental design and development.
- GxP knowledge.
- Neuromodulator or other toxin experience
- Experience creating and maintaining cell banks
- Familiarity with metrology process and instrument (LC, MS, CE) troubleshooting.
- Ph.D. degree in biological sciences or related field with 5+ years of progressive experience in the biotechnology or pharmaceutical industry.
- Candidates with M.S. with extensive experience may be considered.
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Analytical Development Scientist - Newark, United States - Planet Pharma
Description
Location: Newark, CA - onsite
Length: 1 year contract
Pay Rate: $60-$65/hr.
Education: PhD candidates but may consider MS
Experience: Minimum of 5+ years' industry experience required; academic experience is not applicable.
Top Skills:
Job Summary:
We are seeking a Senior Scientist to contribute to our growing Analytical Development team. The Senior Scientist will participate in a team responsible for all aspects of method development, qualification, and execution for the characterization of complex biologics. This position requires hands-on laboratory experience working with analytical techniques for testing of drug substance and drug product to provide phase appropriate analytical development in support of clinical programs to commercial registration and post approval improvements for projects.
This is an on-site, technical laboratory-based position that involves development, qualification, and execution of analytical methods for testing of biologics. The ideal candidate will be expected to work collaboratively and cross-functionally with Process Development, R&D, Formulation Development, QC, and other technical groups by providing analytical testing support.
Essential Duties and Responsibilities:
Requirements/Qualifications:
Additional Experience, preferred but not Required:
Education:
