FSP - Scientist - Analytical Development Testing

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 (Carmel Valley area) 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:

Develops and executes instrumental methods of analyses for development compounds, drug substances, raw materials, intermediates, drug product, and packaging materials to develop assays based on new and existing methodologies. Assists in developing and validating testing methodology used to control raw materials, production intermediates, and final products. Conducts work in compliance with safety and regulatory requirements. May provide analysis and evaluation of material and products at all stages of development process.

• Experience with HPLC, method validation and small molecules is required.
• 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 functional studies for chemical development and formulation development.
• Recognizes and responds to unexpected or anomalous observations in all activities.
• Maintains complete and accurate records of laboratory work in conformance with company standard operating procedures (SOPs) and training.
• Provides detailed reviews of peer generated data as well as that generated from contracted service providers.
• Maintains the inventory of laboratory consumables and clean glassware.
• Coordinates vendors service calls for repair and maintenance of laboratory instruments, with training perform routine maintenance of laboratory instrumentation, maintains complete and accurate records of instrument service and repairs in conformance with company SOPs and policies.
• Performs other duties as assigned.

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, or similar
• Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
• OR Masters degree

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Small molecule experience and HPLC is required

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