What are the responsibilities and job description for the Research Scientist: Biopharm HPLC and GMP position at Thermo Fisher Scientific Careers?
Job Title: Research Scientist
Location: Illinois
Job Type: Full-time
About the Job:
We are seeking a highly motivated Research Scientist to join our Analytical Services team. The successful candidate will be responsible for supporting analytical development and routine testing of new biological entities (NBEs) in a cGMP environment.
Key Responsibilities:
- Independently performs analytical testing, method optimization/validation, and/or other specialty technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems.
- Prepares and reviews study protocols, project status reports, final study reports and other project-related technical documents.
- Routinely demonstrates scientific initiative and creativity in research activities.
- Works with multiple functional groups to meet business needs.
- Sets up and maintains laboratory equipment, optimizes laboratory operations for efficient use of time and resources.
- Leads troubleshooting of equipment and experimental problems.
- Ensures QA findings are addressed appropriately.
- Provides technical guidance and training to staff.
- Communicates project status, data and technical issues to project lead and responds to leaders' needs and questions.
- Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP).
- Performs 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 or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years).
- At least one year of cGMP experience in a regulated lab is required.
- Proficient in Microsoft Excel and Word.
- Proficient in Empower.
- Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance.
- Proven ability to interpret data by performing trend analysis.
- Understanding and knowledge of general chemistry and separation science.
- Proven ability in technical writing skills.
- Proven ability to independently optimize analytical methods.
- Proven problem solving and troubleshooting abilities.
- Effective written and oral communication skills as well as presentation skills.
- Time management and project management skills.
- Ability to independently perform root cause analysis for method investigations.
- Statistical knowledge and experience are preferred.
- Ability to work in a collaborative work environment with a team.
- Ability to be flexible and be able to re-prioritize in a short notice to meet business needs.
- Ability to train and mentor junior staff.
Working Environment:
- 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.
Benefits:
- Competitive remuneration.
- Annual incentive plan bonus.
- Healthcare.
- Range of employee benefits.
Salary Range: $72,000.00–$120,000.00 per year.
Salary : $72,000 - $120,000
