Automation Scientist - 2nd Shift

Thermo Fisher Scientific • Richmond, VA

1d • Onsite

About The Position

Performs immunoassay method development, validation, and troubleshooting in support of pharmacokinetic, toxicokinetic, pharmacodynamic, and immunogenicity (ADA) sample testing involving novel therapeutics (particularly large-molecule biologics) in the pharmaceutical industry. A day in the Life: Perform a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and /or biological matrices for stability and analytical testing. Work with multiple functional groups to meet business needs. Plan and organize work with periodic supervision. Set up and maintain analytical instrumentation. Train in routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines. Ensure QA findings are addressed appropriately. Provide assistance and training for other team members. Problem solving, either independently or with assistance pertaining to extraction and/or instrumentation problems. Communicate project status to project leader. Perform work assignments accurately, and in a time ly and safe manner. Review, interpret, and analyze data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Perform self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

Requirements

• Bachelor's degree in lab sciences such as biology, biochemistry, immunology, chemistry, molecular biology or similar
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) or equivalent combination of education, training, & experience.
• Master’s degree
• Demonstrated knowledge of multiple applicable techniques such as: HPLC, GC, MS, Dissolution Testing, Inhalation Testing, Biopharmaceutical Testing, Karl Fischer, UV-Vis, FT-IR, TOC
• Proficient in Microsoft Excel and Word
• Proven ability to interpret data by performing trend analysis
• Proven ability in technical writing skills
• Ability to independently optimize analytical methods
• Proven problem solving and troubleshooting abilities
• Good written and oral communication skills
• Time management and project management skills
• Ability to work in a collaborative work environment with a team
• 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.
• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.

Responsibilities

• Performs immunoassay method development, validation, and troubleshooting
• Perform a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and /or biological matrices for stability and analytical testing.
• Work with multiple functional groups to meet business needs.
• Plan and organize work with periodic supervision.
• Set up and maintain analytical instrumentation.
• Train in routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines.
• Ensure QA findings are addressed appropriately.
• Provide assistance and training for other team members.
• Problem solving, either independently or with assistance pertaining to extraction and/or instrumentation problems.
• Communicate project status to project leader.
• Perform work assignments accurately, and in a timely and safe manner.
• Review, interpret, and analyze data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
• Perform self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

Benefits

• Annual Bonus
• 401k Match
• PTO
• A 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 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 our 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

What This Job Offers

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