Study Lead GMP Lab, Small Molecule

Work Schedule

Environmental Conditions

Job Description

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 be able to pass a comprehensive background check whichincludes a drug screening.

At Thermo Fisher Scientific youll 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 strategiesand advise clients on study design.

• Support continuous improvement initiatives identify technical obstaclesand 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:

• Bachelors 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 PowerPointTeams 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. Below is listed the working environment/requirements for this role:

• Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

• Able to work upright and stationary and/or standing for typical working hours.

• Able to lift and move objects up to 25 pounds.

• Able to work in non-traditional work environments.

• Able to use and learn standard office equipment and technology with proficiency.

• May have exposure to potentially hazardous elements including infectious agents typically found in healthcare or laboratory environments.

• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

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