Scientist III - Technical Project Manager (Biopharmaceuticals)

Thermo Fisher Scientific • Middleton, WI

83d

About The Position

Position: Scientist III - 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.

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 5+ years).
• Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and applicable regulatory authority, compendia and ICH guidelines.
• Technical experience with Biopharmaceutical methods such as HPLC and CE strongly preferred.
• Ability to understand and independently apply GMPs to everyday work with regard to documentation and instrument use.
• Demonstrates excellent manual dexterity skills.
• Exhibits strong written and oral communication skills.
• Displays exceptional time management and project management skills.
• Proven problem-solving and troubleshooting abilities.
• Ability to independently optimize analytical methods.
• Capable of cross-training on sample preparation techniques with another laboratory group.

Nice To Haves

• Experience in a collaborative work environment.
• Ability to thrive in a fast-paced environment.

Responsibilities

• Independently perform a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations.
• Review and compile results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications.
• Coordinate laboratory activities of other team members in conjunction with the lab supervisor.
• Assist with study design & protocol authoring.
• Lead data evaluation and study close-out.
• Train on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines.
• Complete all laboratory documentation in clear and accurate language according to SOP and GMPs.
• Independently troubleshoot equipment & instruments.
• Mentor others in troubleshooting when applicable.
• Navigate the OOS/OOT/Atypical investigation process.
• Lead investigations and Root Cause Analysis and propose CAPAs.
• Communicate project status to project leader and help to identify gaps and anticipate roadblocks in project team workflow.
• Independently manage QC responsibilities.
• Complete QA facing tasks.
• Author and lead more complex quality records.

Benefits

• Health and wellbeing support.
• Opportunities for career development.
• Access to resources for achieving individual career goals.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees