Senior Scientist - Biologics

Trident Consulting; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Trident Consulting seeks a Senior Scientist - Biologics in Aliso Viejo, CA, onsite. You will lead analytical development for large molecules, validate assays, and coordinate transfers to CROs/CMOs, supporting development from early studies to commercialization.

You will also oversee stability, interpret data for regulatory questions, and contribute to IND/NDAs documentation while mentoring teammates and collaborating across departments.

Qualifications

• PhD with 8+ years or MS with 10+ years in biochemistry or related field.
• 8+ years of pharmaceutical/biotech large molecule analytical development experience.
• Experience with regulatory submissions (INDs/NDAs) and GMP/ICH/GxP.

Responsibilities

• Develop, validate, and transfer analytical and potency assays for large molecules.
• Oversee stability studies and perform trend analyses for drug substances.
• Lead analytical activities on CMC project teams and interact with CROs/CMOs.
• Prepare protocols and technical sections for regulatory submissions and reports.

Skills

Leadership

Cross-functional collaboration

Regulatory awareness

Education

PhD in biochemistry or related field

MS in biochemistry or related field

Tools

HPLC

UPLC

IEX-HPLC

SEC-HPLC

LC-MS

ELISA

qPCR

ddPCR

Octet

Biacore

Job description

Trident Consulting is seeking a “Senior Scientist - Biologics” for one of our clients in “Aliso Viejo, CA - Onsite” — a global leader in Medical devices industry.

Job Title: Senior Scientist - Biologics

Description:

What You’ll Do:

This position is within the Analytical Technologies team of the Applied Research department. This role focuses on developing, validating, and transferring analytical and biological potency assay and cell-based assay methods to support large molecule drug development and formulations from early-stage clinical studies through commercialization. The position also involves overseeing stability studies and conducting trending analysis. The position will establish, coordinate and monitor analytical related activities both internally and with CROs and CMOs to ensure quality and timeliness of projects. The ideal candidate works effectively and collaboratively with cross-functional groups and will represent as analytical lead on CMC project teams. This position is expected to communicate data both verbally at group meetings and through written documents and reports and be able to comfortably multitask across projects and disciplines. Provides technical expertise to design, conduct, and implement analytical and development activities for large and small molecules to support all stages of drug development. Troubleshoots and solves technical challenges independently in a timely manner and ensures generation of high-quality scientific data. Evaluates and interprets data from release and stability studies and provides scientific conclusions to support decision making. Maintains expertise in cutting-edge assay technologies and continuously develops excellent assay troubleshooting skills in analytical methodologies used for the characterization of drug delivery systems and protein formulations for drug release, potency, biological activity, stability, impurity testing and aggregation profile. Collaborate with protein/peptide engineering SMEs and contribute biological knowledge to the design of novel proteins with desired pharmacological characteristics. Prepares high quality experimental protocols and technical reports in support of regulatory submissions. Independently authors appropriate portions of CMC section of INDs, NDAs and prepares responses to regulatory questions. Provides training and guidance to scientists in the team. Provides regular and open communication to keep project teams, and management informed of direction, progress and strategic developments in supporting and meeting companies’ goals and objectives. Actively participates in departmental committees/meetings as an advisor in scientific, administrative and regulatory areas. Represents as analytical lead on CMC project teams, provides scientific solutions and contributes to team discussions. Support QC department with establishing robust methods, product specifications, method validations and method transfers. Proactively develops and maintains knowledge in current analytical and bioanalytical sciences and investigates new technologies, recommends and implements innovative techniques to the team.

Requirements:

How You’ll Get There:

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.