Job Description
This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.) Job Description Title: QC Scientist III As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information Reporting to the Plainville, MA site and supporting the Viral Vector Services (VVS), a division of Thermo Fisher Scientific. At VVS, we deliver from process development through commercial supply, offering the expertise and resources vital to help clients deliver innovative gene therapies. We are placed at the forefront of our leading and groundbreaking Cell and Gene Therapy business, enabling clients to cure genetic, rare, and otherwise untreatable diseases. Discover Impactful Work Join our collaborative team at Thermo Fisher Scientific, where you'll contribute to our mission of making the world healthier, cleaner, and safer. As a QC Scientist III, you'll perform sophisticated analytical testing and provide quality oversight for biopharmaceutical products. You'll work with advanced technology and collaborate with cross-functional teams to ensure product safety and compliance with regulatory requirements. This role offers significant opportunities to grow your expertise while supporting the development and manufacturing of life-changing therapeutics. A Day In The Life You'll conduct complex analytical testing, lead method validations, perform data review, and troubleshoot technical issues. Key responsibilities include executing and reviewing tests for product release, stability, and in-process samples; authoring and reviewing technical documentation; participating in investigations; and interfacing with clients and regulatory authorities. Your work will directly impact patient safety and product quality while advancing scientific innovation. Keys to Success: Education Bachelor’s degree in biological sciences, or related field required. Master's degree, or higher is highly preferred. Preferred Fields of Study: Chemistry, Biology, Biochemistry, or related scientific field Experience 3-5 years of related experience in a GMP pharmaceutical, biopharmaceutical quality control, or regulated environment required, or 2 years with a master or higher degree will be accepted. Contamination control experience required. Experience with quality investigations and CAPAs. Experience with method validation, transfer, and qualification. Knowledge, Skills, Abilities Expertise in analytical techniques such as endotoxin, bioburden, bioburden/endotoxin method suitability, plate enumeration, growth promotion, and BIs. Strong knowledge of FDA, EMA, ICH, ISO, and GxP regulations Proficiency in data analysis and laboratory information management systems Advanced technical writing and documentation skills Strong project management and organizational abilities Knowledge of aseptic practices, aseptic filling, contamination control, and environmental monitoring Ability to work independently and lead cross-functional teams Ability to support microbial risk assessments and root cause analysis Ability to wear PPE and work in laboratory environments May require weekend/flexible scheduling based on business needs Physical requirements include standing, lifting up to 25 lbs, and manual dexterity Strong attention to detail and problem-solving skills Data analysis of environmental monitoring and utility monitoring to support trending of site recoveries Benefits We offer competitive remuneration,