Analytical Science Team Lead
3 weeks ago
We are seeking a highly experienced Senior Analytical Scientist to establish and lead the analytical development program suitable for Quality Control functions in the area of protein biotherapeutics for future GMP production.
About UsThe O'Connor Group is an early-stage biopharma company creating breakthrough protein-based drugs to save lives. We value and encourage innovations through robust information exchange, hard work, and team interaction.
Job DescriptionThis is an exciting opportunity to join a growing, expanding start-up in a full-time position on site in Thousand Oaks, CA. As a Senior Analytical Scientist, you will be responsible for:
- Establishing and leading the development, validation, and optimization of robust analytical methods specific to our protein-based biotherapeutics products.
- Developing, executing, and validating assays and protocols to measure purity, potency, and stability for the purposes of future GMP production.
- Designing and writing SOPs, analytical protocols, and written reports in compliance with GMP as needed.
- Routine lab activities as needed.
To be successful in this role, you must have:
- A Bachelor's degree in biological science or related field. A Master's degree or PhD is preferred.
- Minimum 10-year experience working in a commercial laboratory with hands-on experience in analytical method development and qualification activities.
- Knowledge of GMPs, SOPs, and analytical processes within regulated biologics.
- Experience with accreditation and/or inspection processes is a strong plus.
- Working knowledge of and exposure to phase-appropriate quality systems, including deviations, CAPA, change control, and document management systems.
- Hands-on experience with protein analytical methods, both compendial and non-compendial, such as HPLC (SEC, AEX/CEX, HIC, RP, etc.) and additional product-specific methods such as ELISAs, electrophoretic methods (SDS-PAGE, icIEF), endotoxin, osmolality, pH, and appearance strongly preferred.
We offer a comprehensive benefits package which includes:
- Medical, dental, and vision plans
- 120 hours paid time off (PTO)
- 12 paid holidays annually
- 401(k) U.S. retirement savings plan
- Employee assistance program
Salary: $120,000 - $150,000 per year, depending on experience.
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