Associate Research Scientist - CE, CGE, HPLC
Thermo Fisher Scientific

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Associate Research Scientist - Gene and Cell Therapy TPM

Middleton, Wisconsin, United States of America Full time: Internal/External

Job Description

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:
Possesses a thorough understanding of laboratory procedures and can reliably conduct complex analysis with increased independence. Performs a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices. Follows validated or experimental analytical procedures with periodic direct supervision. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications. Enters data into databases and reports. Performs self-review for own data prior to QC submission.

A day in the Life:

• Support late phase or commercial client on release and stability projects.
• Protocol and method generation, technical support to the team, client communications, nonconformance writing and leading OOS investigations.
• Works with multiple functional groups to meet business needs.
• Plans and organizes work with periodic supervision.
• Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
• Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.
• Plans and organizes work with periodic supervision.
• Sets up and maintains analytical instrumentation.
• Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines.
• Ensures QA findings are addressed appropriately.
• Aids and training to other team members.
• Provides technical guidance and training to staff.
• Leads analytical (procedural and instrumental) troubleshooting sessions.
• Problem solving, either independently or with assistance pertaining to extraction and/or instrumentation problems.
• Communicates project status to project leader and clients.
• Performs work assignments accurately, and in a timely and safe manner.
• Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
• Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

• Assists in preparation and implementation of SOPs and quality systems.
• Communicates data and technical issues to clients on a weekly basis (or as needed).
• Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.

Keys to Success:
Education

MS degree with 5+ years of experience; BS degree with 6+ years of experience.

Experience

• Laboratory experience involving CE, HPLC, ELISA and compendia.
• Experience with Release and Stability programs.
• Prior client interfacing experience needed.
• Experience delivering project completion to timeline.
• Teamwork: data sharing, problem-solving, and collaborating.

Knowledge, Skills, Abilities

• Demonstrated knowledge of multiple applicable techniques such as: HPLC, UPLC, iCE, CGE, MS, ELISA, SDS-PAGE, Biopharmaceutical Testing, Karl Fischer, UV-Vis, FT-IR, TOC
• Proficient in Microsoft Excel and Word
• Proven ability to interpret data by performing trend analysis
• Proven ability in technical writing skills
• Ability to independently optimize analytical methods
• Proven problem solving and troubleshooting abilities
• Good written and oral communication skills
• Time management and project management skills
• Ability to work in a collaborative work environment with a team

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.

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.

This job has expired.