Study Lead - GMP Lab, Small Molecule

Job description

Work Schedule First Shift (Days) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials Job Description Study Lead​Department: Small MoleculeLocation: Middleton, WisconsinAdditional Details: Onsite; Full-Time 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! Role Overview: The Study Lead is responsible for 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, and managing quality records. This role ensures adherence with the regulatory guidelines and scientific conduct of routine testing. The Study Lead directs and oversees testing and troubleshooting on established methods using multiple analytical instruments and detection techniques, evaluates/trends and interprets data, and records data in adherence with Thermo Fisher Scientific, Inc. SOPs and any additional lab or client specific requirements. This role drives routine study execution and technical client communication for established methods and defined scopes but does not independently determine scientific conclusions for non-routine (development, validation, transfer, etc.), or method lifecycle-impacting issues. When investigation outcomes exceed routine complexity, technical direction is consulted from the Senior Study Lead or Staff Scientist + in accordance with Decision Making Framework and Standard Work. The Study Lead is accountable for timely and accurate delivery of routine study outputs, ensuring data integrity, adherence to SOPs and regulatory requirements, and escalating issues to stakeholders and senior technical staff in accordance with established decision frameworks. Role Responsibilities: Collaborate with internal stakeholders to translate project requirements into study design plans and manage project timelines and deliverables. Reinforces best practices through example and delivery of routine study activities. Communicate project plans, status updates, deliverables, and routine technical findings to internal stakeholders and clients, escalating risks, concerns, or non-routine issues as appropriate. Manages multiple routine projects, interacts with clients and internal stakeholders to communicate updates, provides deliverables, reviews and evaluates data, writes reports and protocols, and oversees quality records. Provide guidance, resources, mentoring, and/or training to laboratory staff, fostering independent routine test execution and troubleshooting. Prepare and/or review 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. Monitor daily project-related operations to ensure adherence to SOPs, company policies, and regulatory standards, reporting non-compliance issues to management. Assist in risk assessments, recommend risk mitigation strategies,and advise clients on study design. Support continuous improvement initiatives, identify technical obstacles, and implement process improvement strategies. Participate in project problem-solving sessions, escalate issues when necessary, and incorporate appropriate resources or SMEs to drive effective solutioning. Executes/oversees 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. Applies standard troubleshooting approaches to resolve routine technical issues, leveraging existing knowledge, historical data, and subject matter expert (SME) guidance as needed. Identifies and communicates risks to project timelines, data quality, or deliverables, and escalates appropriately. Support audit readiness by ensuring study documentation, data, and records are complete, accurate, and inspection-ready; participate in client audits or site visits and address audit findings under guidance from senior staff. Key Requirements: Education and Experience: 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). 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, Abilities 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 (eg: Word, Excel, PowerBI, 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. Work Environment Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Be