**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:** + Develop, execute and optimize manual and automated immuno-based assays such as different ELISA, MSD, AlphaLISA, and Biolayer Interferometry + Evaluate and implement novel High Throughput (HTP) automated analytical platforms and robotic liquid handlers for sample preparation, sample run and automated data analysis for immuno-based assays + Develop assay design criteria using Design of Experiments (DOE) and other contemporary development tools + Provide routine analytical testing support to Cell and Gene Process Development activities for immuno-based assays. + Work closely with junior staff to ensure that development timelines are on track for delivery + Work collaboratively with the Analytical Development and Process development group to ensure successful transfer of developed assays and to resolve any technical issues that arise during execution of the transfer. + Maintain meticulous records of experimental workflows, protocols and results and help assist in the generation of documentation to support experiments + Compile information obtained through experimental work into presentations and reports. + Collaborate cross functionally across different teams (PD, AD and other external partners) to ensure timely delivery of data and information. + Some weekend work/holiday work is necessary for the job + Assist with lab organization and compliance with lab safety protocols. + This position is lab-based and requires ~70-80% lab testing and ~20-30% involve in assay development including sample and data management. **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 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, Skills and Abilities:** + Hands-on experience with different immuno-based assays such as MSD, ELISA, AlphaLISA, and Biolayer Interferometry. + Experience with or understanding robotic liquid handers (TECAN, Hamilton or other) and their operating software (Fluent Gx, VENUS, or other) for automated sample preparation. + Hands-on experience and technical proficiency with mammalian cell culture (both 2D and 3D), aseptic technique, cell-based assay development. + Ability to use literature to design proof of concept studies. + Hands on experience with other molecular-based assays such as PCR, flow cytometry, and Nanostring are a plus + Ability to work collaboratively across different teams to ensure methods are successfully developed. + Experienced writing technical documents including development reports, qualification protocols and qualification reports. + Experience with R and python programming is a plus. + Excellent communication and presentation skills with the proven ability to solve complex problems and to work effectively as a member of a multidisciplinary team, detail oriented, multitasking, goal and timeline oriented, and critical thinker. + Understanding process development for cell and gene therapy products. **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.