FSP - Scientist - Analytical Development Reference Standard

Thermo Fisher Scientific•San Diego, CA

7d•$31 - $38•Onsite

About The Position

The Analytical Development Scientist – Reference Standards develops, qualifies, and manages the lifecycle of compendial and internal reference standards for peptide and small-molecule programs. The role supports analytical method development, verification, and validation to ensure procedures are suitable for identity, purity, potency, content, and stability testing. The scientist evaluates materials and analytical data across development stages while following GMP, safety, and regulatory requirements, and collaborates with cross-functional teams to support CMC strategies and regulatory submissions. The position performs and optimizes compendial and non-compendial analytical methods, including instrumental analyses of development compounds, drug substances, raw materials, intermediates, drug products, and packaging materials. It supports stability studies, investigations of atypical or anomalous results, and cross-functional studies for chemical and formulation development. The scientist maintains complete laboratory and instrument records, reviews peer and vendor data, manages laboratory consumables and glassware, and coordinates instrument service and maintenance. This is a fully onsite role at a customer site in San Diego, California (Carmel Valley area). Applicants must be legally authorized to work in the United States without sponsorship and pass a comprehensive background check, including drug screening. Relocation assistance is not provided.

Requirements

Bachelor's degree in laboratory sciences such as Chemistry, Biochemistry, or a similar discipline, with comparable relevant experience of 2 or more years; or a master's degree. An equivalent combination of appropriate education, training, and directly related experience may be considered.
Practical working knowledge of HPLC analysis and troubleshooting.
Knowledge of cGMP expectations for laboratory records and quality systems.
Proficiency with MS Excel, MS Word, and data systems for computer-controlled instrumentation.
Strong knowledge of one scientific discipline and good knowledge of scientific principles, methods, and techniques.
Demonstrated ability to work with a variety of laboratory equipment and tools.
Ability to recognize fundamental anomalies in data and identify issues in experiments or processes.
Ability to evaluate analytical data and draw meaningful conclusions.
Ability to work as part of a team in a timeline-driven setting.
Strong computer skills, communication, problem-solving, analytical thinking, attention to detail, and project management skills.
Ability to meet deadlines and provide ideas for process improvements.
Legally authorized to work in the United States without sponsorship.
Ability to pass a comprehensive background check, including a drug screening.

Responsibilities

Develop, qualify, and execute analytical methods for characterization, qualification, and lifecycle management of reference and working standards for peptide and small-molecule programs.
Apply and optimize compendial (USP/EP/JP) and non-compendial methods for identity, purity, potency, content, and stability testing of reference standards, drug substances, drug products, raw materials, and critical reagents.
Support analytical method development, verification, and validation for reference-standard qualification and routine testing across development stages.
Perform analytical testing using instrumental techniques such as chromatography and spectroscopy in compliance with GMP, safety, and regulatory requirements.
Evaluate analytical data, investigate atypical results, and contribute documentation for reference-standard qualification, change control, and regulatory submissions (IND/IMPD/NDA/BLA).
Collaborate with CMC, Analytical Development, Quality Control, and external vendors to ensure availability, comparability, and traceability of reference standards.
Develop and execute methods using instruments such as HPLC, GC, TGA, DSC, MS, and FTIR for development compounds, drug substances, raw materials, intermediates, drug products, and packaging materials.
Follow established test methods, procedures, and pharmacopeia chapters, including Dissolution, to generate data for strategic decision-making.
With supervision, plan and execute in-house stability studies for drug substances, intermediates, and prototype drug products.
With supervision and as appropriate, assist with or lead analytical method development and investigations into out-of-specification, out-of-trend, or anomalous results.
Collaboratively plan and execute cross-functional studies for chemical development and formulation development, with supervision.
Recognize and respond to unexpected or anomalous observations.
Maintain complete and accurate laboratory records in accordance with company SOPs and training.
Review peer-generated data and data from contracted service providers.
Maintain laboratory consumables and clean glassware inventory.
Coordinate vendor service calls for laboratory instrument repair and maintenance; with training, perform routine instrument maintenance and document service and repairs in accordance with company SOPs and policies.
Perform other duties as assigned.

Benefits

Competitive remuneration and annual incentive plan bonus.
Healthcare benefits, including medical, dental, and vision plans and health incentive programs.
Employee assistance and family support programs.
Commuter benefits.
Tuition reimbursement.
At least 120 hours of paid time off and 10 paid holidays annually.
Paid parental leave, including 3 weeks for bonding and 8 weeks for caregiver leave.
Accident and life insurance.
Short- and long-term disability coverage.
401(k) retirement savings plan.
Employee Stock Purchase Plan offering eligible colleagues company stock at a discount.
Career and development prospects.