Associate Research Scientist - Technical Project Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

This is a fully onsite role based at our GMP Lab 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 guides. As the world leader in serving science, our laboratory professionals bring their dedication to accuracy and quality to deliver groundbreaking innovations.

Essential Functions

• Independently perform analytical testing, method optimization/validation, and conduct specialty technology studies for pharmaceutical and biopharmaceutical compounds. You will be crafting and completing experiments with proven precision.
• Review and critique study protocols, project status reports, final study reports, and other project-related technical documents, ensuring they meet our world-class standards.
• Communicate complex data and technical issues to clients regularly, providing updates that demonstrate our dedication to flawless execution.
• Provide technical mentorship and training to staff, encouraging a collaborative and inclusive work environment.
• Lead analytical troubleshooting sessions, ensuring that any issues are resolved promptly and effectively.
• Assist in the preparation and implementation of SOPs and quality systems, contributing to our outstanding compliance record.
• Review, interpret, and analyze data for technical, quality, and compliance, performing both self and peer reviews to maintain the highest standards.

Keys to Success:

Education and Experience:

• 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 6+ 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, Skills, and Abilities:

• Previous experience writing investigations and deviations
• Previous GMP experience preferred
• Previous client facing experience preferred
• Ability to independently perform root cause analysis for method investigations.
• Proficiency on technical operating systems.
• Proven problem-solving and troubleshooting abilities.
• Strong technical writing skills.
• Outstanding time management and project management skills.
• Strong written and oral communication skills.
• Ability to work collaboratively in a team environment.
• Capability to train and mentor junior staff.

Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced en