Bioassay Scientist
Job Description
Join a pioneering CDMO specializing in Gene Therapies as a Bioassay Scientist within the Bioassay team. This role is integral to supporting site-wide quality initiatives, with a focus on method transfers, qualifications, validations, and cross-functional collaboration. You will provide robust analytical support for biologics and gene therapy platforms, ensuring the success of nucleic acid and cell-based assays.
Responsibilities
- Perform and execute analytical method lifecycle activities including method transfers, qualifications, validations, and stability testing.
- Engage in method lifecycle projects involving HPLC.
- Draft and maintain technical documents such as protocols, SOPs, and reports to support regulatory and operational compliance.
- Support routine and investigational stability testing protocols, ensuring timely and accurate data generation.
- Train and mentor junior QC analysts to ensure consistent execution of analytical procedures and lifecycle activities.
- Conduct root cause analysis for OOS/OOT investigations, contributing to continuous improvement and CAPA implementation.
- Collaborate with internal and external stakeholders to ensure phase-appropriate testing, data trending, and technical reporting aligned with regulatory expectations.
Essential Skills
- GMP - 5 years of previous pharmaceutical experience.
- Bioassay experience - ELISA, PCR, ddPCR.
- Method Validation/Method Transfer - 5+ years of experience transferring methods and ensuring they are validated.
- Proficiency in protocol writing and technical writing, specifically in a GMP setting, transferring, and validating methods, including HPLC.
Additional Skills & Qualifications
Work Environment
This position is based on-site in Durham at a startup company with strong financial backing from Europe. The site is actively engaging with numerous customer inquiries and is rapidly building a team to support its clients. This is an exciting opportunity to join at the forefront of establishing a new presence in the US
Job Type & LocationThis is a Contract position based out of Durham, NC.
Pay and BenefitsThe pay range for this position is $51.00 - $51.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace TypeThis is a fully onsite position in Durham,NC.
Application DeadlineThis position is anticipated to close on Jul 29, 2026.