Senior Scientist, Chromatography

Thermo Fisher Scientific • Richmond, VA

22h

About The Position

The Senior Scientist conducts advanced laboratory testing and helps ensure the accuracy and reliability of laboratory data. The role performs and guides routine-to-complex sample preparation and analysis to quantitatively measure pharmaceutical and biopharmaceutical compounds in various formulations and biological matrices for stability and analytical testing. The Senior Scientist also mentors colleagues, coordinates laboratory activities, contributes to study design and protocol authoring, and supports continuous improvement in laboratory methods and quality standards.

The position requires independent application of SOPs and applicable regulatory requirements, accurate laboratory documentation, instrument troubleshooting, quality control, and management of investigations and quality records. Work is performed in a laboratory and/or clinical environment and involves collaboration with project teams and laboratory colleagues.

Requirements

• Bachelor’s degree or equivalent and relevant formal academic or vocational qualification.
• At least 5 years of comparable experience, or an accepted combination of appropriate education, training, and directly related experience.
• Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and applicable regulatory authority, compendia, and ICH guidelines.
• Ability to interpret and consider SOPs and regulatory guidelines during study design activities.
• Ability to independently apply GMPs and/or GLPs to everyday work, including documentation and instrument use.
• Excellent manual dexterity for precise and accurate work.
• Strong written and oral communication skills.
• Strong time-management and project-management skills.
• Problem-solving and troubleshooting abilities.
• Ability to independently optimize analytical methods.
• Ability to perform under stress and multitask.
• Regular and consistent attendance.

Nice To Haves

• Experience or capability in cross-training on sample preparation techniques with another laboratory group.

Responsibilities

• Train on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines.
• Independently perform and guide routine-to-complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in formulations and biological matrices for stability and analytical testing.
• Complete laboratory documentation clearly and accurately according to SOPs and GLPs.
• Independently troubleshoot equipment and instruments and mentor others in troubleshooting when applicable.
• Review and compile results and make initial determinations of acceptability against SOP acceptance criteria.
• Navigate OOS/OOT/atypical investigations; lead investigations and root-cause analyses; and propose CAPAs.
• Perform work accurately, in a timely manner, and safely.
• Independently manage QC responsibilities and communicate project status to the project leader, identifying gaps and anticipating workflow roadblocks.
• Coordinate laboratory activities of other team members with the lab supervisor.
• Assist with study design and protocol authoring; lead data evaluation and study close-out.
• Independently complete QA-facing tasks and author and lead complex quality records, including records requiring in-depth root-cause investigation or cross-departmental input.
• Cross-train on sample preparation techniques with another laboratory group.
• Demonstrate behaviors aligned with Thermo Fisher’s 4i Values.

Benefits

• Choice of 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 (PTO) and 10 paid holidays annually.
• Paid parental leave: 3 weeks for bonding and 8 weeks for caregiver leave.
• Accident and life insurance.
• Short- and long-term disability in accordance with company policy.
• 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan offering eligible colleagues the opportunity to purchase company stock at a discount.
• Variable annual bonus may be available based on company, team, and/or individual performance results, in accordance with company policy.

What This Job Offers

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