Study Lead - Biopharm

Study Lead

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.

• 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.

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

• Previous experience that provides the knowledge, skills, and…