Automation Scientist - 2nd Shift
Thermo Fisher Scientific
Summary
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.
Job description
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 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.
Education
Bachelor's degree in lab sciences such as biology, biochemistry, immunology, chemistry, molecular biology or similar.
Experience
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years') or equivalent combination of education, training, & experience. OR Master's degree. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities
- 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
Requirements
- Bachelor's degree in lab sciences such as biology, biochemistry, immunology, chemistry, molecular biology or similar
- Previous experience comparable to 2+ years or equivalent combination of education, training, & experience
- Demonstrated knowledge of 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
- 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
Benefits
- Medical, Dental & Vision
- Health Incentive Programs
- Employee Assistance Program
- Family Support Programs
- Commuter Benefits
- Tuition Reimbursement
- Paid Time Off
- Paid Holidays
- Paid Parental Leave
- Accident Insurance
- Life Insurance
- Short & Long-Term Disability
- 401(k) Matching
- Employee Stock Purchase Plan
- Annual Bonus
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.