Sr Biologics Scientist

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. With a highly engaged leadership team and a reputation for delivering hard-to-fill, niche talent , we help organizations build agile, high-performing teams that drive innovation and business success.

Trident Consulting is seeking a "Sr Biologics Scientist " for one of our clients in " Aliso Viejo, CA (Onsite)" A global leader in business and technology services.

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

Trident Consulting is a premier IT staffing firm providing high-impact workforce solutions to Fortune 500 and mid-market clients. Since 2005, we've specialized in sourcing elite technology and engineering talent for contract, direct hire, and managed services roles. Our expertise spans cloud, AI/ML, cybersecurity, and data analytics, supported by a 3M+ candidate database and a 78% fill ratio. With a highly engaged leadership team and a reputation for delivering hard-to-fill, niche talent, we help organizations build agile, high-performing teams that drive innovation and business success. Learn more: tridentconsultinginc.com .

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 TechServe 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.