Senior Analytical Scientist
Senior Analytical Scientist
Posted on :
06-12-2024
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
06-12-2024
Job Description
Company Summary:
Who we are: 20bloc Inc. is an earlystage biopharma company creating breakthrough proteinbased drugs to save lives. We are developing a safe and effective hemoglobinbased oxygen carrier for first response organ preservation and oxygen therapy. We value and encourage innovations through robust information exchange hard work and team interaction. We are collaborative we are intellectual we are handson.
Position Overview:
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. This is an exciting opportunity to join a growing expanding startup in a fulltime position on site in Thousand Oaks CA.
Key responsibilities:
Establish and lead the development validation and optimization of robust analytical methods specific to our proteinbased biotherapeutics products.
Develop execute and validate assays and protocols to measure purity potency and stability for the purposes of future GMP production. Examples include ELISA gel electrophoresis and chromatographicbased assays and qualification activities for inprocess and final release of drug substance and drug products.
Design and write SOPs analytical protocols and written reports in compliance to GMP as needed.
Routine lab activities as needed.
Requirements
Requirements:
Bachelor s degree in biological science or related field. Master s degree or PhD preferred.
Minimum 10year experience working in a commercial laboratory with handson 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.
Handson experience with protein analytical methods both compendial and noncompendial such as HPLC (SEC AEX/CEX HIC RP etc.) and additional productspecific methods such as ELISAs electrophoretic methods (SDSPAGE icIEF) endotoxin osmolality pH and appearance strongly preferred. Experience with LCMS analyses and potency assay
development and execution a strong plus.
Experience with PCR Western Blot and MSbased methods a strong plus.
Excellent interpersonal verbal and written communication skills and the ability to work crossfunctionally such as with process development are essential in this collaborative work environment.
Strong attention to detail and excellent organizational skills are required.
Benefits
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
Bachelor s degree in biological science or related field. Master s degree or PhD 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. Experience with LC-MS analyses and potency assay development and execution a strong plus. Experience with PCR, Western Blot and MS-based methods a strong plus. Excellent interpersonal, verbal and written communication skills and the ability to work crossfunctionally such as with process development, are essential in this collaborative work environment. Strong attention to detail and excellent organizational skills are required
Employment Type
Full Time
Key Skills
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