Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
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.
Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
Key responsibilities:
Analysis of chemical development and formulation samples using HPLC
Assistance in LC method development to support drug substance and drug product analysis
Participating in the planning and execution of experiments
Maintains accurate records of experiments and results in a laboratory notebook and authors reports as assigned.
Interpretation and communication of results. The ability to present results in both oral and written reports is required.
Maintains general lab equipment, including HPLC, GC, and KF
Troubleshooting of instruments and experiments
Demonstrates responsible follow-up
Demonstrates knowledge of scientific principles and basic understanding of applicable drug development regulations
Education and Experience:
Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
Assoc Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0-2+ years')
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 and Abilities:
Knowledge of analytical chemistry, HPLC, impurity analysis, residual solvent analysis
GC and KF experience is NICE TO HAVE
Knowledge of applicable regulatory authority, compendial and ICH guidelines is a plus
Ability to work successfully in both a team/matrix environment as well as independently is required
Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use
Ability to use ELN, Empower is a plus, and Microsoft Excel and Word to perform tasks
Excellent written and verbal communication skills. The abilities to maintain accurate scientific documentation and effectively communicate scientific results is essential.
The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects is essential.
Problem solving and troubleshooting abilities
Working Environment:
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.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
