Research Scientist - Technical Project Manager (GMP)

Thermo Fisher Scientific•Middleton, WI

1d•Onsite

About The Position

Position: Research Scientist - 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 Research Scientist, you will perform and oversee routine to complex analytical testing and study activities in a GMP-regulated laboratory, supporting pharmaceutical and biopharmaceutical client programs. You will review and evaluate data to ensure results meet approved methods, specifications, and quality standards, with a strong focus on accurate, compliant documentation. In this role, you will support and lead investigations, deviations, and atypical results, contributing to root cause analysis and driving quality records to closure. You will manage multiple studies, author protocols and reports, and act as a client-facing technical resource, providing project updates and supporting resolution of technical and quality-related issues.

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 8+ 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
Proven technical and quality writing skills, including authoring protocols, reports, and quality records in GMP environment strongly preferred
Intermediate knowledge of relevant scientific principles applicable to role
Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA mentorship
Full knowledge of technical operating systems
Ability to independently optimize analytical methods
Ability to independently perform root cause analysis for method investigations
Proven technical writing skills
Proven problem solving and troubleshooting abilities
Effective written and oral communication skills as well as presentation skills
Time management and project management skills
Ability to mentor others on technical operating systems
Ability to independently review and understand project proposals/plans
Ability to work in a collaborative work environment with a team
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.

Responsibilities

Trains on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines.
Independently performs and provides guidance on complex sample preparation and analytical procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds across a variety of formulations and matrices for stability and analytical testing.
Completes all laboratory documentation clearly, accurately, and compliantly, in accordance with SOPs, GMP, and GLP requirements, with a strong emphasis on high-quality technical writing.
Leads advanced troubleshooting for various equipment & instruments.
Reviews and compiles results from assignments and makes determination on acceptability per SOP acceptance criteria. Reviews overall study results.
Navigates the OOS/OOT/Atypical investigation process. Leads more complex investigations and Root Cause Analysis and leads CAPAs.
Independently manages QC responsibilities.
Communicates project status to project leader and helps to address gaps and solutions to overcoming roadblocks in project team workflow. May act as project leader.
Coordinates and supervises laboratory activities of other team members in conjunction with lab management.
Performs 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.)
Mentors other staff members in applicable areas