Scientist III – Chromatography (CE/HPLC) and Method Development and Validation Full-time NEW

Job Title

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. 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:

Independently performs a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications. 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.

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).

Knowledge, Skills, Abilities:

• Demonstrated experience in GMP environment
• Previous method development & validation experience preferred
• Previous HPLC & CE experience preferred
• 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

Work Environment:

• 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 100,000+ 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.

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.