Sr Biologics Scientist
Job in
Aliso Viejo, Orange County, California, 92656, USA
Listed on 2026-08-05
Listing for:
Trident Consulting
Full Time, Seasonal/Temporary
position Listed on 2026-08-05
Job specializations:
-
IT/Tech
Data Analyst, Data Scientist, Information Security & Data Protection
Job Description & How to Apply Below
Role:
Sr Biologics Scientist
Locations:
Aliso Viejo, CA (Onsite)
Type: Full-time
Job Description:
- Strong hands-on knowledge of chromatographic theory and technology.
- Working knowledge of HPLC, UPLC, IEX-HPLC, SEC-HPLC, LC-MS, CE techniques, cIEF, MSD, ELISA, ddPCR, qPCR, Octet, Biacore, and other common analytical and bioassay techniques used to determine potency, purity, and in-vitro performance of drug substance and drug product for large molecules.
- Ability to independently lead investigations and troubleshoot technical problems at all stages of development, being detail oriented are important attributes.
- Excellent written and verbal communication skills; prior experience working within regulated environments (e.g., GxP, ICH, FDA) to ensure analytical activities meet compliance standards and support regulatory filings and inspections.
- Strong ability and knowledge to develop, validate and transfer methods. Experience in oversight of stability studies, conducting trend analysis and interpreting data.
- Strong scientific and leadership skills with the ability to be a subject matter expert at matrix teams and influence and collaborate.
- Ability to work within a diverse workforce, scientific participation and collaboration with colleagues in industry, academia and regulatory agencies.
- Experience in interacting with pharmaceutical CROs and CMOs and providing guidance. Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
- Strong knowledge of Quality systems, Drug Product Manufacturing and Validation. Good knowledge of drug development and product regulations.
- Ph.D. (with 8+ years) or M.S. (10+ years) in biochemistry, immunoanalytical/analytical chemistry, or related scientific field and 6+ years of pharmaceutical industry experience in large molecule analytical development, drug product analysis and regulatory submissions.
Must have
- Analytical Methodical developments for large molecules
- Able to collaborate with the team
- Be able to engage and work with CRO and CDMO
Learn more: .
Some of our recent awards include:
- Trailblazer Women Award 2025 by Consulate General of India in San Francisco.
- Ranked as the #1 Women Owned Business Enterprise in the large category by ITServe.
- Received the Tech Serve Excellence award.
- Consistently ranked in the Inc. 5000 list of fastest-growing private companies in America.
- Recognized in the SF Business Times as one of the Largest Bay Area BIPOC/Minority-Owned Businesses in 2022.
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×