Associate Research Scientist - Technical Project Manager

Middleton, WI

Computer and Electronic Product Manufacturing

About the position

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!

Responsibilities

• Responsible for the regulatory and scientific conduct of development, validation, stability projects, and/or other specialty technologies such as extractable/leachable studies.
• Performs troubleshooting on multiple analytical instrumentation and multiple detection techniques.
• Calculates and interprets data, and records data in adherence with PPD SOPs and any additional requirements specific to the lab and/or client.
• Acts as the technical project leader for multiple projects.
• Interacts with clients on a weekly basis (or as needed) to provide updates.
• Reviews and evaluates data, writes reports and protocols.
• Independently performs analytical testing, method optimization/validation, and/or other specialty technologies studies or method transfers for pharmaceutical and biopharmaceutical compounds.
• Understands and conforms to methods and protocols applicable to assigned tasks.
• Designs and performs experiments independently.
• Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
• Prepares and reviews study protocols, project status reports, final study reports and other project-related technical documents.
• Communicates data and technical issues to clients on a weekly basis (or as needed).
• Provides technical guidance and training to staff.
• Leads analytical (procedural and instrumental) troubleshooting sessions.
• Assists in preparation and implementation of SOPs and quality systems.
• 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.

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 BS degree plus 6+ years' of experience or MS plus 4+ years' of experience, or PhD plus 2+ years' of experience).
• Demonstrated knowledge of HPLC, CE, iCE or ELISA strongly preferred.
• Method Development/Validation preferred.
• Experience with quality investigations and technical documentation generation (protocols and methods) strongly preferred.
• Previous GMP experience preferred.
• Ability to independently perform root cause analysis for method investigations.
• Proficiency on technical operating systems.
• Proven problem solving and troubleshooting abilities.
• Proven ability in technical writing skills.
• Time management and project management skills.
• Good written and oral communication skills.
• Ability to work in a collaborative work environment with a team.
• Ability to train junior staff.

Benefits

• Thermo Fisher Scientific values the health and wellbeing of our employees.
• Support and encourage individuals to create a healthy and balanced environment.