Bioanalytical Study Manager

Thermo Fisher Scientific • Morrisville, NC

1d • Remote

About The Position

Join Us as a Bioanalytical Study Manager - Labs – Make an Impact at the Forefront of Innovation This is a fully remote role supporting our customer’s site in Eastern and Central Time Zones. We welcome applicants from all locations within the US. 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. Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner. Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. Summarized Purpose Join our dynamic team and lead the charge in supporting our clients development pipeline from a bioanalytical perspective. You'll manage bioanalytical operations for pre-clinical studies and clinical trials, ensuring timely delivery of quality data by coordinating activities between multiple stakeholders.

Requirements

• BA/BS in a scientific degree + 2 years’ experience in a Bioanalytical laboratory.
• Experience of working in a regulated environment
• Understanding of clinical trial design
• Good project management background
• Strong communication and collaboration skills
• Strong large molecule immunoassay-based bioanalysis experience
• Experience performing PK/ADA assays is required

Nice To Haves

• Ideally with translational or biomarker experience
• Experience with biomarker techniques and/or flow cytometry is highly preferred.
• Flow Cytometry experience preferred
• Multicolor panel design Compensation and gating strategy
• Using instruments like BD FACSCanto, LSRFortessa, Cytek Aurora
• Data analysis in FlowJo
• PBMC handling and staining

Responsibilities

• Vendor Management: Support the team contracting with third-party lab service providers for assay development and validation. Collaborate with business operations, procurement, and clinical teams to ensure appropriate SOWs and contracts.
• Study Coordination: Manage critical reagent supply and sample analysis. Work closely with bioanalytical strategy leads, clinical trial teams, and lab service providers to finalize study documents and meet timelines.
• Documentation & Data: Provide input into clinical trial documents (e.g., eCRFs, ICFs, SOWs). Drive the delivery of data transfer specifications and ensure data accuracy.
• Sample Logistics: Track and reconcile sample testing, resolving any issues that arise.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees