FSP - Scientist, Analytical Development Testing - Reference Standard

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

ONSITE:

This is a fully onsite role based at our customer’s site in San Diego, CA We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. 

Must be legally authorized to work in the United States without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers’ organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies.

Key responsibilities:

The Analytical Development Scientist- Reference Standards is responsible for the development, qualification, and lifecycle management of compendial and internal reference standards supporting small-molecule programs. This role executes and supports analytical method development, verification, and validation activities to ensure the suitability of testing used for identity, purity, potency, and stability assessments. The scientist performs data-driven evaluation of materials across all stages of development in compliance with GMP, safety, and regulatory requirements, and collaborates cross-functionally to support CMC strategies and regulatory submissions.

• Develops, qualifies, and executes analytical methods for the characterization, qualification, and lifecycle management of reference standards and working standards for peptides and small-molecule programs, including compendial and non-compendial materials.
• Applies and optimizes compendial (USP/EP/JP) and non-compendial analytical methods to support identity, purity, potency, content, and stability testing of reference standards, drug substances, drug products, raw materials, and critical reagents.
• Supports method development, verification, and validation activities to ensure suitability of analytical procedures used for reference standard qualification and routine testing across development stages.
• Performs analytical testing using a variety of instrumental techniques (e.g., chromatography, spectroscopy, as applicable) in compliance with GMP, safety, and regulatory requirements.
• Evaluates analytical data, investigates atypical results, and contributes to documentation supporting reference standard qualification, change control, and regulatory submissions (IND/IMPD/NDA/BLA).
• Collaborates with CMC, Analytical Development, Quality Control, and external vendors to ensure availability, comparability, and traceability of internal and compendial reference standards.
• Develops and executes instrumental methods (e.g. HPLC, GC, TGA, DSC, MS, FTIR) of analyses for development compounds, drug substances, raw materials, intermediates, drug product, and packaging materials.
• Accurately follows established test methods, procedures, and pharmacopeia chapters (e.g. Dissolution) to generate data essential for strategic decision making.
• With supervision, plans and executes in-house stability studies for drug substance’s, intermediates, and prototype drug products.
• With supervision and as appropriate, assists/leads the development of analytical methods, investigations for out of specification, out of trend, and/or anomalous results.
• With supervision, collaboratively plans and executes cross functi