Biologics Analytical Development Scientist

Trident Consulting; Irvine (CA); On-site; USD 118,000 - 148,000; Full time

Benefits offered by this job

Potential bonus and stock awards

Job summary

Trident Consulting is seeking a Senior Biologics Analytical Scientist in Aliso Viejo, CA. The role focuses on method development, validation, and transfer for large-molecule drug development, leading projects, and coordinating with CROs/CDMOs.

You will perform hands-on lab work, operate instruments, and support regulatory submissions. The position emphasizes independent leadership, cross-functional collaboration, and adherence to GxP, ICH, and FDA guidelines.

Qualifications

• PhD with 8+ years of experience or MS with 10+ years in Biochemistry/Analytical Chemistry or related field.
• At least 6 years of pharma industry experience in large-molecule analytics and regulatory submissions.
• Strong hands-on experience in method development, validation, troubleshooting, and transfer for large molecules.
• Ability to independently initiate, lead, and execute lab projects and resolve technical problems.
• Experience with CROs/CMOs/CDMOs and providing technical direction.
• Experience with stability studies, trend analysis, and analytical characterization.
• Knowledge of GxP, ICH, FDA requirements and regulatory filings.
• Strong scientific communication, writing, project mgmt, and cross-functional collaboration.

Responsibilities

• Develop, validate, and transfer analytical methods for large molecules.
• Lead hands-on laboratory experiments and operate analytical instruments.
• Support analytical characterization of proteins, peptides, and formulations.
• Conduct stability studies and trend analyses to inform decisions.
• Coordinate analytical activities with internal teams and CROs/CDMOs.
• Serve as analytical lead on CMC project teams for regulatory submissions.
• Develop methodologies for drug release, potency, and purity assessments.
• Prepare protocols, reports, and documentation for IND/NDA submissions.
• Collaborate with protein/peptide engineering teams on novel proteins.

Skills

Method development

Regulatory submissions

CRO/CDMO oversight

Team leadership

GxP/ICH/FDA compliance

Large molecule analytics

Education

PhD or MS in Biochemistry/Analytical Chemistry

Tools

HPLC/UPLC

IEX-HPLC

SEC-HPLC

CE

cIEF

ELISA

ddPCR

qPCR

Octet

Job description

Trident Consulting is seeking a \"Senior Biologics Analytical Scientist\" for one of our clients in Aliso Viejo, CA. Our client is a global leader in business and technology services.

Job Title: Senior Biologics Analytical Scientist

Salary Range: $118,000 – $148,000 Annually

Additional Benefits: Potential bonus and stock awards

Position Overview

We are seeking an experienced Senior Scientist to join the Analytical Technologies team within the Applied Research department. This is a highly hands-on laboratory position focused on analytical method development, validation, and transfer for large-molecule drug development and formulations.

The ideal candidate will independently lead analytical projects, perform laboratory experiments, operate analytical instruments, troubleshoot complex technical challenges, and collaborate with cross-functional teams. The role also involves managing external partnerships with Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs), supporting regulatory submissions, and representing the analytical function on Chemistry, Manufacturing, and Controls (CMC) project teams.

Key Responsibilities

• Develop, validate, and transfer analytical methods, biological potency assays, and cell-based assays to support large-molecule drug development from early-stage clinical studies through commercialization.
• Perform hands-on laboratory experiments, independently operate analytical instruments, interpret results, and troubleshoot technical challenges.
• Support analytical characterization of proteins, peptides, drug delivery systems, and pharmaceutical formulations.
• Conduct stability studies, evaluate release and stability data, perform trend analysis, and provide scientific conclusions to support decision-making.
• Establish, coordinate, and monitor analytical activities with internal teams and external CROs, CMOs, and CDMOs to ensure quality and timely project execution.
• Serve as the analytical lead on CMC project teams, providing scientific expertise and contributing to cross-functional discussions and project strategies.
• Develop and implement analytical methodologies for drug release, potency, biological activity, stability, impurity testing, purity, and aggregation profiling.
• Prepare experimental protocols, technical reports, and scientific documentation to support regulatory submissions.
• Independently author relevant CMC sections of Investigational New Drug (IND) and New Drug Application (NDA) submissions and prepare responses to regulatory questions.
• Collaborate with protein and peptide engineering subject matter experts to support the design of novel proteins with desired pharmacological characteristics.
• Partner with Quality Control (QC) to establish robust analytical methods, product specifications, method validations, and method transfers.
• Ensure analytical activities comply with applicable GxP, ICH, FDA, and other relevant regulatory requirements.
• Provide technical guidance and training to scientists and contribute to departmental scientific, administrative, and regulatory initiatives.
• Manage multiple projects, evaluate resource requirements, and communicate project progress, challenges, and strategic developments to stakeholders and management.
• Evaluate emerging analytical technologies and recommend innovative approaches to improve analytical development and characterization capabilities.

Required Qualifications

• Ph.D. with 8+ years of experience or M.S. with 10+ years of experience in Biochemistry, Analytical Chemistry, Immunoanalytical Chemistry, or a related scientific field.
• At least 6 years of pharmaceutical industry experience in large-molecule analytical development, drug product analysis, and regulatory submissions.
• Strong hands-on experience in analytical method development, validation, troubleshooting, and method transfer for large molecules.
• Demonstrated ability to independently initiate, lead, and execute laboratory projects and resolve complex technical problems.
• Experience working with pharmaceutical CROs, CMOs, and/or CDMOs, including providing technical direction and oversight.
• Experience with stability studies, trend analysis, data interpretation, and analytical characterization.
• Knowledge of regulated pharmaceutical development environments, including GxP, ICH, FDA requirements, and regulatory filings.
• Strong understanding of quality systems, drug product manufacturing, validation, and pharmaceutical product regulations.
• Excellent scientific communication, technical writing, project management, and cross-functional collaboration skills.
• Ability to manage multiple priorities, work independently, and contribute effectively within a diverse scientific team.

Technical Skills

Chromatography and Analytical Techniques

• HPLC and UPLC
• Ion-Exchange HPLC (IEX-HPLC)
• Size-Exclusion HPLC (SEC-HPLC)
• Capillary Electrophoresis (CE)
• Capillary Isoelectric Focusing (cIEF)

Bioanalytical and Bioassay Techniques

• ELISA
• Digital Droplet PCR (ddPCR)
• Quantitative PCR (qPCR)
• Octet
• Biological potency and cell-based assays

Analytical Development and Regulatory Expertise

• Large-molecule analytical method development
• Method validation and transfer
• Protein and peptide characterization
• Drug product analysis and formulation development
• Stability studies and trend analysis
• Impurity, purity, aggregation, and potency assessment
• CMC documentation and IND/NDA regulatory submissions
• GxP, ICH, and FDA compliance
• CRO/CDMO/CMO oversight
• Quality systems and pharmaceutical manufacturing validation

About Trident Consulting

Trident Consulting is an award-winning staffing and consulting firm headquartered in San Ramon, CA. Since 2005, we’ve partnered with Fortune 500 and high-growth companies to deliver high-quality talent across technology, engineering, business operations, and professional services.

We specialize in contract, contract-to-hire, and direct hire placements, supporting roles across IT, data & analytics, cloud, cybersecurity, finance & accounting, HR, operations, and more. With a strong focus on hard-to-fill and niche positions, our global recruiting engine enables us to deliver speed, quality, and scale.