Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Scientist II - Physical and Chemical Characterization - Method Development and Validation
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
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Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
Discover Impactful Work:
Possesses an understanding of laboratory procedures and under general supervision can conduct complex analysis. Performs a variety of routine and non-routine sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices in support of method development and validation. Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory guidelines. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications.
A day in the Life:
- Performs a variety of routine and non-routine sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices in support of method development and validation.
- Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory guidelines.
- Communicates project status to project leader.
- Maintains a laboratory notebook and completes all laboratory documentation in clear and accurate language and according to SOP and GLPs.
- Performs daily work assignments accurately, and in a timely and safe manner.
- Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
- Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.
Keys to Success:
Education
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Experience
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered enough for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities
- Knowledge of routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory guideline
- Knowledge of applicable regulatory authority, compendia and ICH guidelines
- Excellent manual dexterity skills
- Good written and oral communication skills
- Time management and project management skills
- Proven problem solving and troubleshooting abilities
- Ability to cross-train on sample preparation techniques with another laboratory group
- Ability to work in a collaborative work environment with a team
Work Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- 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.