**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. **Key responsibilities:** + Author and/or review technical documents such as method development reports, method validation protocols and reports, and technical transfer documentation. + Engage CROs and internal stakeholders in biologics analytical methods remediation or performance improvement. + Assist with QMS activities (Change Controls, Impact Assessments, Change Actions) related to analytical lifecycle management & related activities. + Perform data verification, trending, and statistical analysis to support regulatory strategy and product characterization. + Collaborate cross-functionally with internal stakeholders and external partners to support overall analytical readiness for product commercialization and ongoing lifecycle activities. **Education and Experience:** + 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 4+years’)** + OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job **(comparable 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, Skills and Abilities:** + Experience in Analytical Development, Quality Control and related analytical functions for Biologics, particularly from late-stage development through commercialization. + Proficiency in analytical techniques, such as HPLC, CE, iCIEF, Protein Titer, SoloVPE, or impurity methods. + Familiarity with GMP, CLP, and regulatory guidance such as ICH, USP/EP/JP, applicable to analytical methods and commercial-stage CMC. + Demonstrated experience in SOP and technical report writing, especially validation and technical transfer documents, is highly desired. + Demonstrated experience in developing and designing method transfer and validation studies per ICH and FDA guidelines is highly desired. + Prior experience with reference material qualification and inventory management is a plus. + Familiarity with commercial program lifecycle, QMS systems, and regulatory submission expectations is preferred + Effective collaboration, communication, prioritization, and multitasking skills. **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.