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
Experience with HPLC.
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 & Location
This is a Contract position based out of Durham, NC.
Pay and Benefits
The 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 Type
This is a fully onsite position in Durham,NC.
Application Deadline
This position is anticipated to close on Jul 15, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
