Bioanalytical Study Manager

Work Schedule

Environmental Conditions

Job Description

Join Us as a Bioanalytical Study Manager - Labs Make an Impact at the Forefront of Innovation

This is a fully remote role supporting our customers 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 withoutsponsorship.

Must be able to pass a comprehensive background check whichincludes a drug screening.

Thermo Fishers 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 whileallowing 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. Youll manage bioanalytical operations for pre-clinical studies and clinical trials ensuring timely delivery of quality data by coordinating activities between multiple stakeholders.

Essential Functions:

• 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.

Education and Experience:

• Education: BA/BS in a scientific degree 2 years experience in a Bioanalytical laboratory.
• Experience:
  • 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
    • Ideally with translational or biomarker experience
  • Experience performing PK/ADA assays is required
  • Experience with biomarker techniques and/or flow cytometry is highly preferred.
  • Flow Cytometry experience preferred

In somecasesan 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:

• Strong organizational and analytical skills.
• Excellent written/verbal communication.
• Ability to work both independently and as part of a team.
• Multicolor panel design
• Compensation and gating strategy
• Using instruments like BD FACSCanto LSRFortessa Cytek Aurora
• Data analysis in FlowJo
• PBMC handling and staining

Working 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:

Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
Occasional drives to site locations occasional domestic travel.
Exposure to biological fluids with potential exposure to infectious organisms.
Rare exposure to skin and lung irritants radiation toxic materials and hazardous waste.
Personal protective equipment required such as protective eyewear garments and gloves.
Exposure to fluctuating and/or extreme temperatures on rare occasions.

Why join us
When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.