Senior Scientist

Trident Consulting is seeking a   Sr. Scientist” for one of our clients in  Aliso Viejo, CA (Onsite)” A global leader in business and technology services.

Trident Consulting is seeking an experienced Senior Scientist to support pharmaceutical product formulation and process development across multiple technology platforms. This role will focus on drug formulation, process optimization, technology transfer, and supporting product commercialization for biologics, combination products, and drug delivery systems. The ideal candidate will have strong experience in pharmaceutical development, formulation science, and cGMP-regulated environments.

We are seeking an experienced Senior Scientist to support pharmaceutical product formulation and process development across multiple technology platforms. This role will focus on drug formulation, process optimization, technology transfer, and supporting product commercialization for biologics, combination products, and drug delivery systems. The ideal candidate will have strong experience in pharmaceutical development, formulation science, and cGMP-regulated environments.

• Develop robust formulations and manufacturing processes for biologic drugs, combination products, and drug delivery systems.
• Lead formulation development, process optimization, and process improvement activities for mid- to late-stage pharmaceutical products.
• Design and execute laboratory experiments, process analytical technology (PAT) studies, and product characterization activities.
• Support technology transfer and process transfer to Manufacturing, Operations, CMOs, and CROs.
• Collaborate with cross-functional teams including R&D, Engineering, Manufacturing, Regulatory Affairs, Quality Assurance, and Quality Control.
• Analyze experimental data, prepare technical reports, present findings, and recommend next development steps.
• Review and approve study data, documentation, and technical reports while ensuring regulatory compliance.
• Develop, review, and maintain SOPs and technical documentation.
• Ensure all laboratory work complies with cGLP, cGMP, and applicable regulatory requirements.
• Evaluate new technologies, formulation strategies, competitor products, and scientific literature to support product innovation.
• Participate in project team meetings and provide scientific leadership throughout development activities.

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Master's degree with 6+ years of relevant industry experience OR
• PhD with 4+ years of relevant pharmaceutical/biotech experience.
• Minimum 5+ years of hands‑on experience in pharmaceutical or biotechnology product formulation and process development.
• Experience developing pharmaceutical formulations and/or biologic drug products.
• Strong understanding of technology transfer and process transfer activities.
• Experience working in regulated cGLP and cGMP environments.
• Knowledge of ICH Guidelines, particularly Q2, Q3, Q5, Q6, and Q11.
• Experience creating and maintaining SOP documentation.
• Strong analytical, documentation, and technical writing skills.
• Excellent verbal and written communication skills.
• Proficiency with Microsoft Excel, Word, PowerPoint, and laboratory instrument software.

• Experience with protein formulation and characterization.
• Experience in biologic drug development.
• Hands‑on experience with Process Analytical Technology (PAT).
• Experience with biopharmaceutical formulation development and biologic assays.
• Previous experience supporting CMOs/CROs and commercial manufacturing transfers.

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.