Study Lead - GMP, Cell & Gene Therapy

Thermo Fisher Scientific • Middleton, WI

13d • Onsite

About The Position

This is a fully onsite role based at our GMP Laboratory in Middleton, WI. 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. Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Requirements

• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’ experience) or equivalent combination of education, training, & experience
• Knowledge of routine analytical testing and applicable technology/instrumentation
• Excellent organizational skills with the ability to adapt and adjust to changing priorities while maintaining focus, composure and productivity
• Versed in data analysis to identify trends or outliers
• Ability to manage multiple assignments with challenging/conflicting deadlines
• Proficient in Microsoft suite applications (e.g.: Word, Excel, Power BI, PowerPoint, Teams, SharePoint)
• Familiarity of data collection software leveraged for analytical testing
• Strong attention to detail and problem-solving skills
• Effective written and verbal communication skills including technical writing
• Demonstrated experience in identification and resolution of conflicts in a professional environment
• Ability to maintain a high degree of confidentiality with client information and data
• Ability to attain, maintain and apply a working knowledge of applicable procedural documents
• Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others
• Demonstrated ability to receive and apply constructive feedback
• Ability to train, coach and mentor junior staff
• Working knowledge of GMP requirements and data integrity principles
• 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

Nice To Haves

• 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.

Responsibilities

• Managing multiple routine projects (release, stability, and quality control)
• Interacting with clients and internal stakeholders to communicate updates
• Providing deliverables
• Reviewing and evaluating data
• Writing scientific reports and protocols
• Managing quality records
• Ensuring adherence with the regulatory guidelines and scientific conduct of routine testing
• Directing and overseeing testing and troubleshooting on established methods using multiple analytical instruments and detection techniques
• Evaluating/trending and interpreting data
• Recording data in adherence with Thermo Fisher Scientific, Inc. SOPs and any additional lab or client specific requirements
• Driving routine study execution and technical client communication for established methods and defined scopes
• Collaborating with internal stakeholders to translate project requirements into study design plans and manage project timelines and deliverables
• Reinforcing best practices through example and delivery of routine study activities
• Communicating project plans, status updates, deliverables, and routine technical findings to internal stakeholders and clients, escalating risks, concerns, or non-routine issues as appropriate
• Providing guidance, resources, mentoring, and/or training to laboratory staff, fostering independent routine test execution and troubleshooting
• Preparing and/or reviewing routine study protocols, project status reports, final study reports, and other project-related technical documents inclusive of quality records
• Collate, organize, and evaluate/trend data to ensure accuracy, integrity, and compliance with protocols, methods, and SOPs
• Monitoring daily project-related operations to ensure adherence to SOPs, company policies, and regulatory standards, reporting non-compliance issues to management
• Assisting in risk assessments, recommending risk mitigation strategies, and advising clients on study design
• Supporting continuous improvement initiatives, identifying technical obstacles, and implementing process improvement strategies
• Participating in project problem-solving sessions, escalating issues when necessary, and incorporating appropriate resources or SMEs to drive effective solutioning
• Executing/overseeing studies within established methods, protocols, and decision frameworks, escalating non-routine, complex, or ambiguous issues to senior technical staff
• Accountable for timely and accurate delivery of routine project outputs, ensuring data integrity and compliance with SOPs, regulatory requirements, and client expectations
• Applying standard troubleshooting approaches to resolve routine technical issues, leveraging existing knowledge, historical data, and subject matter expert (SME) guidance as needed
• Identifying and communicating risks to project timelines, data quality, or deliverables, and escalating appropriately
• Supporting audit readiness by ensuring study documentation, data, and records are complete, accurate, and inspection-ready; participating in client audits or site visits and addressing audit findings under guidance from senior staff

Benefits

• Relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level