Scientist III - Technical Project Manager (GMP, Biopharmaceuticals)

Thermo Fisher Scientific•Middleton, WI

10d•Onsite

About The Position

Position : Scientist III - Technical Project Manager Location : Middleton, Wisconsin Department : Biopharmaceutical 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. Discover Impactful Work: The Scientist III – Technical Project Manager (TPM) serves as a scientific and technical lead, managing studies from sample receipt through final data delivery while ensuring quality, timelines, and client expectations are met. This role is responsible for technical project activities including document generation, milestone coordination with internal partners, client communication, secondary data review, QA audit support, quality investigations, and final release of results. The Scientist III TPM ensures all data and documentation meet SOPs, methodologies, protocols, and product specifications and supports study design, data evaluation, and study close-out activities. While primarily project-focused, the role may also support hands-on laboratory testing as needed to assist with study execution and troubleshooting.

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). 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 of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and applicable regulatory authority, compendia and ICH guidelines and ability to interpret and consider SOP and regulatory guidelines during study design activities.
Ability to understand and independently apply GMPs to everyday work with regard to documentation and instrument use.
Demonstrates excellent manual dexterity skills, allowing for precise and accurate work.
Exhibits strong written and oral communication skills, facilitating effective communication within the team and with stakeholders.
Displays exceptional time management and project management skills, ensuring efficient completion of tasks.
Proven problem-solving and troubleshooting abilities, enabling the identification and resolution of issues.
Ability to independently optimize analytical methods
Capable of cross-training on sample preparation techniques with another laboratory group, enhancing versatility and collaboration.
Thrives in a collaborative work environment, actively contributing to a cohesive and productive team.
To demonstrate behaviors which align to the 4i Values of Thermo Fisher
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.

Nice To Haves

Technical experience with Biopharmaceutical methods such as HPLC and CE strongly preferred

Responsibilities

Trains on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines.
Independently performs and gives guidance on a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and for stability and analytical testing.
Completes all laboratory documentation in clear and accurate language according to SOP and GMPs.
Independently troubleshoots equipment & instruments.
Mentors’ others in troubleshooting when applicable.
Reviews and compiles results from assignments and makes initial determination on acceptability per SOP acceptance criteria.
Navigates the OOS/OOT/Atypical investigation process.
Leads investigations and Root Cause Analysis and proposes CAPAs.
Performs work assignments accurately, and in a timely and safe manner.
Independently manages QC responsibilities.
Communicates project status to project leader and helps to identify gaps and anticipates roadblocks in project team workflow.
Coordinates laboratory activities of other team members in conjunction with the lab supervisor.
Assists with the study design & protocol authoring.
Leads data evaluation and study close-out.
Independently completes QA facing tasks.
Authors and leads more complex quality records (eg. quality records which may require more in-depth investigation to identify true root causes, quality records requiring cross-departmental input and/or collation of data etc.