**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **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. 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:** Project support of pharmaceutical operational activities for the Reference Standard and Critical Reagent (RSCR) Group within Global Quality Control Operations and Analytical Science (GQCAS) organization. Primary role will be to support project / product interaction and operational needs within the RSCR Operations group including ownership and facilitation of key aspects for biologics and small molecules. + Project support for RSCR portfolio to meet project deliverables and timelines. + Maintain communication with stakeholders and key partners regarding material supplies and deliverables. + Assures that protocols, supporting data, reports, and certificate of analysis (COA) are property documented, reviewed, and issued based on current SOPs. Verifies that the physical inventory and inventory operations (i.e. receiving bulk material, subdividing material, labeling, storage, and disposition) are maintained and up-to-date. + Address potential risks and operational issues by identifying, documenting, resolving, communicating or escalating to senior leadership when appropriate. + Collaborate with key stakeholders to manage expectations. Interacts with the respective reference standard re-qualification process including developing test protocols, reviewing data, scheduling testing, calculating purity, and assigning expiration dates. + Monitors key aspects of the business such as inventory and burn rate analysis, and actively participate in investigations and providing documentation/filing support. Will support laboratory activities associated with aliquoting large molecule programs and adhere to GxP and EHS regulations for good laboratory practices and safety. + Work well within diverse/inclusive high performance teams and maintain a strong relationship with operational and functional leadership. **Education and Experience:** + Bachelor's degree in Biomedical Engineering, or similar + Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 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:** + Directly support qualification and operational activities for the Reference Standard and Critical Reagent (RSCR) Group within the Global Quality Analytical Science and Technology (GQAST) organization. + Function as a subject matter expert for biologic (large molecule) reference standards to support all aspects of qualifications, investigations, procurement, and inventory burn rate for the RSCR science and qualifications team. + Manage and oversee an aggressive portfolio of reference standards and critical reagents programs to meet project deliverables and timelines. + Embrace collaboration with stakeholders, customers, and team members, while operation with integrity, as well as seeking and participating in the continuous improvements of systems and culture. + Closely monitor key aspects of the business such as inventory and burn rate analysis, and actively participate in investigations and providing documentation and expertise supporting Biologics License Application (BLA) filings, + Sustained, concise communication with departmental team leaders, project managers, Quality Assurance, and Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs. + Support for commercial and clinical programs, including lab work, office work, teleconferencing, computer work, and running/attending meetings. + By using prior laboratory automation experience, facilitate automated liquid handler qualifications through procuring required equipment/ supplies authoring qualification protocols, coordinating with contract service providers, and executing qualifications. + Train additional RSCR staff on operation/maintenance of automated liquid handlers. + Program automated liquid handler protocols for the use of clinical and commercial drug product aliquoting and participate in aliquoting sessions to ensure continued success. + Author Job Aid and Preventative Maintenance documentation for continuous successful RSCR liquid handler usage. + Maintain laboratory supplies inventory for aliquoting activities through quote generation, PO generation, and coordinating timely shipping **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! Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.