Contract - Senior Associate/Scientist – Analytical Development
On-siteNewark, California, United States
Job Summary
Execute technical analytical methodologies to support development and validation of test methods for complex biologics. Author and review analytical methods, protocols, reports, and technical documents, including instrument qualification and change control. Operate and maintain sophisticated analytical instrumentation and associated computer control systems. Provide support for laboratory operations, including inventory tracking, reagent preparation, sample management, and documentation review. Execute analytical and biological methods ensuring compliance with ICH guidelines and global regulations. Train other qualified staff to ensure effective execution of roles and responsibilities. Interact with contract manufacturers and contract testing laboratories to provide support for regulatory submissions.
Required Qualifications
- Experience performing basic analytical assay techniques such as absorbance and fluorescence plate-based assays, immunoassays (AlphaLISA, ELISA, SPR, and western blot), SoloVPE, and SDS-PAGE/CE-SDS
- Familiarity in interpreting data from common characterization techniques such as HPLC, AUC, SEC-MALS, MFI, DLS, and CD
- Experience developing/authoring protocols, methods, and SOPs
- Ability to communicate technically and strategically across technical and operational activities and work collaboratively to ensure successful execution
- Strong written and verbal communication skills
- 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
Desired Qualifications
- Master's degree in biological sciences or related field with 3+ years of progressive experience in the biotechnology or biopharmaceutical industry
- PhD with minimal industry experience may be considered
- Bachelor's degree in biological sciences or related field with 5+ years of progressive experience in the biotechnology or biopharmaceutical industry
- Outstanding academic achievements may be considered in combination with industry experience
- Strong experience with immunoassays is highly desired
- HPLC experience is a plus
- Experience working in a GMP setting is preferred
- Knowledge of SoftmaxPro and/or Empower is a plus
- Experience in drafting protocols, methods, and/or procedures
- Experience or working knowledge of neurotoxin therapeutic development
- Experience in performing change control, deviation, laboratory investigation, and/or other quality records
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