Protein Scientist - Analytical Lead (CA, CA)
Position Overview: We are seeking a senior anlaytical protein-scientist with 10-15 years of biotech industrial experience to lead the analytical development of our hemoglobin based oxygen carrier, from the non-clinical /cGMP stage to beyond. This is a full-time position, on-site in Thousand Oaks, CA, for a self-driven professional. Key responsibilities:
- Lead and execute the development of robust analytical methods for protein-based products.
- Identify and prioritize assays both in-house and outsourced; establish vendors and contracts as needed.
- Qualify starting, in-process and final release of materials.
- Validate assays and protocols to measure purity, potency, and stability to GMP standards, including ELISA, gel electrophoresis and chromatographic-based assays.
- Set up lab and storage including samples for control and long-term stability programs.
- Design, write and help document SOPs, analytical protocols, CoA and reports to GMP standards.
- Bachelor’s degree or above in biological sciences and/or chemistry
- 10-15 years industrial experience in analytical method development and qualification activities.
- Track record in analytical method development for protein biologics, 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, potency assays, PCR, Western Blot, LC-MS and other MS-based methods.
- Experience in transitioning to GMP , including SOP development, methods validation, and phase appropriate quality systems, including deviations, CAPA, change control, and document management systems.
- Strong problem Solving Skills (identify issues and root causes), communication skills (explain complex concepts and issues succinctly), interpersonal skills (seek buy-in and collaboration), and attention to details are essential in this role.
Recommended Jobs
Express Automotive Service Advisor (Entry-Level / Customer Service)
Job Description Job Description Description: Founded in 2008 by David Pedder, Pedder Automotive Group is a family-owned dealership network with 7 locations across Southern California , repres…
Spa Boutique Sales Associate (Seasonal)
Press space or enter keys to toggle section visibility We believe that life is made of many journeys: inspiration, wonderment, curiosity, or the simple joy of discovering something new e…
Consultant, Data Analytics
Job Description Job Description Beghou brings over three decades of experience helping life sciences companies optimize their commercialization through strategic insight, advanced analytics, and …
Dispatcher
Shift: Nights & Weekends (2:30pm - 11:00pm)** **Responsibilities:** - Answer phones in a timely, friendly, and professional manner. - Dispatch calls for service based on skills needed, driver pr…
Design Leader, Interiors
Who We Are HMC Architects is an employee-owned design firm with an inherent desire to make a difference in our communities. As a purpose-driven brand based on values, our mission to design for good d…
Registered Nurse - Surgical, Trauma, Transplant Intensive Care Unit - 5SCCT - 12-Hour Nights - $5,000 Hiring Incentive!!
Job Description Make a difference every single day When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared …
Driver - $35/hr - San Francisco
Description -- Sidecar is a smartphone app that matches everyday people in their own car with people nearby looking for a ride. It's a fast, safe and fun way to get around the city, meet new peop…
Per Diem Field RN - Home Health
Job Overview Aarris Healthcare is seeking experienced and compassionate Per Diem Field Registered Nurses (RNs) for home health visits throughout the greater Sacramento area including Sacramento, E…