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Science Jobs in Aliso Viejo, CA

Sr Biologics Scientist

Trident Consulting

Aliso Viejo, CA

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JOB DETAILS
SKILLS
Analysis Skills, Analytical Chemistry, Analytical Development, Artificial Intelligence (AI), Biochemistry, Biological Assay, Biotech and Pharmaceutical, Business Services, CMOS, Chromatography, Cloud Computing, Communication Skills, Consulting, Contract Research Organization (CRO), Data Analysis, Detail Oriented, Droplet Digital PCR (ddPCR), Drug Development, Drug Manufacturing, Drug Products, FDA (Food and Drug Administration), Fortune 500 Customers, GxP, High Performance Liquid Chromatography (HPLC), ICH Regulations, Identify Issues, International Business, Internet Security, Leadership, Liquid Chromatography-Mass Spectrometry (LC-MS), Microsoft Windows CE Operating System, Multitasking, People Management, Presentation/Verbal Skills, Product Testing, Project Evaluation, Project/Program Management, Real-time PCR (qPCR), Regulations, Regulatory Compliance, Regulatory Submissions, Requirements Management, Securities and Exchange Commission (SEC), Team Player, Technical Recruiting, Trend Analysis, Writing Skills
LOCATION
Aliso Viejo, CA
POSTED
8 days ago
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.

About the Company

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Trident Consulting

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