Analytical Scientist - Microbiologist

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.