Scientist III - Technical Project Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

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:

As a Scientist III you will independently perform a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations. You will be responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications. Additionally, you will coordinate laboratory activities of other team members in conjunction with the lab supervisor and assists with the study design & protocol authoring, and lead data evaluation and study close-out.

A Day in the Life:

• 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.

Keys to Success:

Education

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

Experience

• 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/o