Sr. Scientist - Reference Standard Coordinator

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific, youll 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.

• Planning, coordination and review of commercial reference standard qualification, requalification, and withdrawal.
• Oversees distribution of reference standard requests including inventory management and timely order fulfillment
• Partners with Analytical Science and Technology- Drug Substance team for sourcing and development of specifications for new reference standards
• Understands the analytical procedures utilized for chemical and physical characterization of materials and how these tests relate to the analytical control strategies
• Reviews of analytical characterization testing performed at third party laboratories
• Assists in troubleshooting of analytical methods and/or equipment as required
• Supports OOS/OOT investigations/deviations and identifies corrective actions to prevent reoccurrence
• Authors, reviews, and/or approve data and COAs
• Ensure all laboratory records adhere to cGMP/GDP expectations
• Monitor, track and publish metrics for the reference standard program
• Serve as additional laboratory testing staff to augment quality control support of internal and external manufacturing operations.

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years)
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
• OR PhD

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 of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections
• Knowledge of analytical methodologies such as FTIR, NMR, ROI, chromatography, Karl Fisher, NMR and applying/interpretation of GMP requirements
• Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail
• Ability to drive continuous improvement and implement novel solutions.
• Ability to influence without authority and negotiate positive outcomes
• Ability to effectively influence remote teams and stakeholders
• Strong technical writing to support analytical investigations, deviations, SOP creation/update
• Effective communication skills, both verbal and written

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.

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!