Senior Scientist, Chromatography

Thermo Fisher Scientific•Richmond, VA

About The Position

The Senior Scientist conducts advanced analytical testing in a laboratory setting, ensuring the accuracy and reliability of laboratory data. The role includes mentoring other scientists, supporting continuous improvement in laboratory methodologies and quality standards, and performing pharmaceutical and biopharmaceutical sample preparation and analysis for stability and analytical testing. The Senior Scientist independently performs and guides routine to complex laboratory work, troubleshoots instruments, evaluates results, manages quality-control responsibilities, and leads investigations and root-cause analyses. The role also supports study design and protocol authoring, leads data evaluation and study close-out, and coordinates laboratory activities with other team members and the laboratory supervisor. Work is performed in a laboratory and/or clinical environment, with occasional travel to domestic sites. The position involves potential exposure to biological fluids and infectious organisms, required use of personal protective equipment, and the physical and concentration demands described in the posting.

Requirements

  • Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
  • Previous experience comparable to 5+ years.
  • Knowledge of analytical instrumentation operation, maintenance, and theory; 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 in daily 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 work collaboratively and contribute to a cohesive team.
  • Ability to demonstrate behaviors aligned with Thermo Fisher's 4i Values.
  • Ability to perform under stress, multitask, and adapt to variable demands and changing conditions.
  • Regular and consistent attendance.

Responsibilities

  • Train on the routine operation, maintenance, and theory of complex analytical instrumentation, as well as SOPs and regulatory procedures and guidelines.
  • Independently perform and provide guidance on routine to complex sample preparation and analysis to quantitatively measure pharmaceutical and biopharmaceutical compounds in formulations and biological matrices for stability and analytical testing.
  • Complete laboratory documentation clearly and accurately in accordance with SOPs and GLPs.
  • Independently troubleshoot equipment and instruments, and mentor others in troubleshooting when applicable.
  • Review and compile results, make initial determinations of acceptability under SOP acceptance criteria, navigate OOS/OOT/atypical investigations, lead investigations and root-cause analyses, and propose CAPAs.
  • Perform work accurately, on time, and safely.
  • Independently manage QC responsibilities and communicate project status to the project leader, helping identify gaps and anticipate workflow roadblocks.
  • Coordinate laboratory activities of other team members in conjunction 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 investigation or cross-departmental input.
  • Cross-train on sample preparation techniques with another laboratory group.

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 and 10 paid holidays annually.
  • Paid parental leave, including 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.
  • 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.
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