FSP - Scientist - Analytical Development Reference Standard

Thermo Fisher Scientific • San Diego, CA

5d • Onsite

About The Position

The Analytical Development Scientist – Reference Standards develops, qualifies, and manages the lifecycle of compendial and internal reference standards supporting peptide and small-molecule programs. The role supports analytical method development, verification, and validation, and performs testing to establish identity, purity, potency, content, and stability in accordance with GMP, safety, and regulatory requirements. The position is fully onsite at a customer site in San Diego, California, in a laboratory setting. Applicants must be legally authorized to work in the United States without sponsorship and pass a background check, including drug screening. Relocation assistance is not provided.

The scientist uses compendial and non-compendial methods to characterize reference standards, drug substances, drug products, raw materials, intermediates, critical reagents, and packaging materials. The role evaluates results, investigates atypical observations, maintains compliant records, and contributes documentation for qualification, change control, and regulatory submissions. Working with CMC, Analytical Development, Quality Control, and external vendors, the scientist helps ensure reference-standard availability, comparability, and traceability.

With supervision, the scientist plans and conducts stability and cross-functional studies, supports method development and investigations, reviews peer and vendor data, and maintains laboratory consumables, glassware, and instruments. The position also includes coordinating instrument service and performing routine maintenance after training.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, laboratory science, or a similar field, with comparable experience of 2 or more years; alternatively, 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.
• 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 data anomalies and identify issues in experiments or processes.
• Ability to work effectively as part of a team in a timeline-driven setting.
• Strong computer skills and good communication, problem-solving, and analytical-thinking skills.
• Detail orientation and ability to meet deadlines.
• Good project-management skills.
• Ability to provide ideas for process improvements.
• Legally authorized to work in the United States without sponsorship.
• Ability to pass a comprehensive background check, including drug screening.

Nice To Haves

• Expertise in evaluating analytical data and drawing meaningful conclusions.

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.
• Support analytical method development, verification, and validation for reference-standard qualification and routine testing.
• Perform analytical testing using instrumental techniques, including chromatography and spectroscopy, in compliance with GMP, safety, and regulatory requirements.
• Develop and execute methods such as HPLC, GC, TGA, DSC, MS, and FTIR for development compounds, drug substances, raw materials, intermediates, drug products, and packaging materials.
• Follow established methods, procedures, and pharmacopeia chapters to generate data for decision-making.
• Plan and execute in-house stability studies for drug substances, intermediates, and prototype drug products, with supervision.
• Assist with or lead, as appropriate and with supervision, analytical method development and investigations of out-of-specification, out-of-trend, or anomalous results.
• Collaboratively plan and execute cross-functional studies for chemical and formulation development, with supervision.
• 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 support availability, comparability, and traceability of reference standards.
• Recognize and respond to unexpected or anomalous observations.
• Maintain complete and accurate laboratory records in accordance with company SOPs and training requirements.
• Review peer-generated data and data from contracted service providers.
• Maintain laboratory consumables and clean glassware.
• Coordinate vendor service calls and, after training, perform routine instrument maintenance; maintain service and repair records in accordance with SOPs and policies.
• Perform other duties as assigned.

Benefits

• Competitive remuneration and eligibility for a variable annual incentive bonus.
• National medical and dental plans and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours of paid time off and 10 paid holidays annually.
• Paid parental leave: 3 weeks for bonding and 8 weeks for caregiver leave.
• Accident and life insurance, plus short- and long-term disability coverage in accordance with company policy.
• 401(k) retirement savings plan.
• Employee Stock Purchase Plan, offering eligible colleagues the opportunity to purchase company stock at a discount.
• Career and development prospects.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level