FSP - Scientist - Small Molecule Analytical Development Testing

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. Relocation assistance is not provided; candidates are responsible for their own relocation costs. Must be legally authorized to work in the United States without sponsorship and able to pass a comprehensive background check, including drug screening.

About the role

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. Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by embedding 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.

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 the development process.
• 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 substances, 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 vendor service calls for repair and maintenance of laboratory instruments; with training, performs 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.

Requirements

• 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 a Master's degree. In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience will be considered sufficient.
• Small molecule experience and HPLC is required.
• Recognizes fundamental anomalies in data points and identifies issues in experiments/processes.
• Begins to understand how to think outside of the technical process and consider the impact decisions will have on broader scientific goals.
• Strong knowledge of one scientific discipline.
• Good knowledge of scientific principles, methods, and techniques.
• Good knowledge and demonstrated ability working with a variety of laboratory equipment/tools.
• Ability to work as part of a team to meet goals and tasks in a timeline-driven setting.
• Strong computer skills.
• Good communication, problem-solving, and analytical thinking skills.
• Detail-oriented with the ability to meet deadlines.
• Good project management skills.

Skills

• Proficient in using MS-Excel, MS-Word, as well as data systems for computer-controlled instrumentation.
• Practical working knowledge of conducting HPLC analysis and troubleshooting.
• Some expertise in evaluating analytical data and drawing meaningful conclusions.
• Knowledge of cGMP expectations for laboratory records and quality systems.
• Ability to provide ideas for process improvements.

Schedule

Standard (Mon-Fri).

Environmental Conditions

• Adherence to all Good Manufacturing Practices (GMP) and Safety Standards.
• Laboratory setting with some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Pay

The hourly pay range estimated for this position based in California is $31.00–$38.50. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

Benefits

• Comprehensive Total Rewards package including healthcare (medical, dental, vision) with health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave).
• Accident and life insurance, and short- and long-term disability in accordance with company policy.
• Retirement and savings programs, such as a competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount.