Assoc Research Scientist – GxP Operations

Work Schedule First Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting Job Description FSP – Assoc Research Scientist – GxP Operations Shift: Full-Time; Monday – Friday; 8am-5pm EST ONSITE: This is a fully onsite role based at our customer’s site in (Boston, MA). We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. 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. Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers’ organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies. Key responsibilities: Lead, write and review deviations and investigations for the Drug Product Facility, Facilities, Materials Management and the Kilo Lab. Performs Process Analytical Technology (PAT) Operator tasks during GMP manufacture Review executed batch records to ensure compliance with GDP/GMP requirements Author and approve workflows for batch records, SOPs, WIs and other documents for VMC operations Education and Experience: Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar ARS: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+years’) OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ years’) OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2+ 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: Knowledge of regulatory requirements and principles governing GMP manufacturing Excellent planning and organizational skills, with the ability to balance production, development, and continuous improvement needs Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint) Working Environment: Below is listed the working environment…

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