FSP Associate Research Scientist: Analytical Outsourcing

Job description

Work Schedule First Shift (Days) Environmental Conditions 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. Summary: The Analytical Outsourcing manages end-to-end testing programs, research specifications, and quality oversight for raw materials and packaging components supporting clinical drug product manufacturing, within the External Partner Management team, part of Product Development Operations. This full-time position provides ownership of outsourced testing governance, specification lifecycle management, and cross-functional collaboration across Analytical Development, Product Development, Manufacturing, Supply Chain, Quality Assurance, Procurement, and Regulatory Affairs. Key Responsbilities: Research Specification Development and Lifecycle Management • Author, review, and maintain research specifications for raw materials and packaging components used in clinical development programs. • Define material quality attributes, test requirements, acceptance criteria, and sampling plans. • Collaborate with Analytical Development, Product Development, Manufacturing, Quality Assurance, and Regulatory Affairs to establish fit-for-purpose specifications. Raw Material and Packaging Components Testing Oversight • Coordinate qualification and testing of raw materials, excipients, process aids, manufacturing support materials, and primary packaging components used in clinical drug product manufacturing. • Develop and maintain ANSI-based sampling plans for packaging component inspection and testing to ensure statistically sound sampling and acceptance criteria. • Partner with internal Quality Control and analytical laboratories to prioritize and execute testing activities. • Ensure effective communication of testing priorities and business needs. Outsourced Testing Governance • Serve as the primary business contact for contract testing laboratories. • Coordinate sample submissions, testing requests, technical discussions, data reviews, and issue resolution with external laboratories. • Manage vendor performance through KPIs, business reviews, and service-level expectations. Quality Systems and Compliance • Ensure testing activities comply with GMP, data integrity requirements, company procedures, and applicable regulatory expectations. • Create Change Management records in Infinity to revise existing vendor test methods and/or research specifications. • Create Deviation records for SOP deviations, testing failures, and Out-of-Specification (OOS) results originating at contract testing laboratories. Stakeholder and Vendor Management • Build strong partnerships with suppliers, contract testing laboratories, and internal stakeholders. • Lead routine governance meetings and business reviews with testing vendors. Knowledge, Skills, and Abilities: • Develops, validates and implements immunoassays for the analysis of clinical and non-clinical pharmacokinetic or toxicokinetic samples in a GLP environment with some level of guidance • Contributes to validation and other analytical reports, BAS sections to the TK and clinical study reports. Contributes to the preparation of BAS sections to regulatory filings, BAS responses to regulatory filings, SOP’s, and other guidelines • Processes bioanalytical study samples using validated methods. • Reports study sample results to clients following the departmental policies and procedures. • Troubleshoots and fixes ordinary assay problems • Ensures compliance with and maintains required training in BMS and departmental GLP, SOP, safety and other departmental guidelines • Ensures that electronic notebooks and other documentations are up to date as per departmental guidelines • Achieves objectives in a manner consistent with the Core BMS Behaviors • Prepares and makes scientific presentations at internal and external meetings Education/Experience • Bachelor's degree in relevant life sciences program field • AND 6-8 years of relevant experience 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. • Experience managing raw material and packaging component testing programs supporting clinical manufacturing. • Experience authoring, reviewing, and maintaining research specifications and quality documentation. • Strong understanding of GMP regulations, supplier management, laboratory operations, and quality systems. • Working knowledge of ANSI sampling standards and experience developing statistically justified sampling plans using ANSI methodologies. • Familiarity with USP–NF, European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP) monographs and associated testing requirements for raw materials and packaging components. • Experience managing deviations, change controls, investigations, and CAPA activities within regulated quality systems. • Proficiency with SharePoint Sites and Lists, Power BI, Microsoft Excel, Microsoft Word, and Microsoft PowerPoint. • Strong technical writing, data review, and documentation skills. • Excellent communication, project management, and cross-functional collaboration abilities. Preferred Qualifications: • Experience supporting clinical-stage drug product manufacturing. • Experience overseeing external contract testing organizations and laboratory networks. • Knowledge of raw material and packaging component qualification programs. • Experience with Infinity, electronic quality management systems (eQMS), LIMS, and ERP platforms. • Experience managing supplier relationships, vendor governance programs, and performance metrics. • Familiarity with risk assessment methodologies and material lifecycle management processes. 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 w