Analytical Scientist - Microbiologist

Trident Consulting; California; On-site; USD 120,000 - 180,000; Full time

Job summary

Trident Consulting is hiring an Analytical Scientist - Microbiologist in Aliso Viejo, CA, onsite. The role focuses on analytical method development for large molecules, with emphasis on chromatography and regulatory-compliant practices.

You will lead investigations and work with CROs/CMOs to ensure project success. The position requires a PhD with extensive pharma experience or an MS with substantial industry background, plus strong leadership and data analysis skills.

Qualifications

• Ph.D. with 8+ years or M.S. with 10+ years in biochemistry or related field and 6+ years pharma industry experience.
• Experience with large molecule analytical development, drug product analysis and regulatory submissions.
• Ability to lead investigations and troubleshoot across development stages.
• Excellent communication skills and experience in regulated environments (GxP, ICH, FDA).
• Strong leadership and ability to influence matrix teams.

Responsibilities

• Lead analytical method development, validation, and transfer for large molecules.
• Oversee stability studies, trend analysis, and data interpretation.
• Collaborate with CROs/CMOs and internal teams to support regulatory filings.
• Manage multiple projects and allocate resources efficiently.

Skills

Chromatography theory

HPLC/UPLC

Bioanalytical method development

Regulatory compliance (GxP)

Project management

CRO/CMO collaboration

Education

PhD in Biochemistry / Immune Analytical / Analytical Chemistry

MS in Biochemistry / Immune Analytical / Analytical Chemistry

Tools

HPLC/DAD/LC-MS instruments

qPCR / ddPCR

cIEF / MSD / ELISA

Biacore / Octet

Job description

We’re hiring for a “Analytical Scientist - Microbiologist” role in “Aliso Viejo, CA (Onsite)” with one of our industry-leading clients. This is a long-term opportunity, with competitive pay, and the team is actively scheduling interviews.

Role: Analytical Scientist - Microbiologist

Employment Type: Full-Time

Must have:

• Analytical Methodical developments for large molecules
• Able to collaborate with the team.
• Be able to engage and work with CRO and CDMO.

How You’ll Get There (Requirements):

• 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, immune analytical/analytical chemistry, or related scientific field and 6+ years of pharmaceutical industry experience in large molecule analytical development, drug product analysis and regulatory submissions.