"Alerted.org

Job Title: - Analytical Method Lifecycle Specialist

Job Description

Join a dynamic and innovative team as a Specialist in a company specializing in gene therapies. This role is essential in supporting site-wide quality initiatives by focusing on method transfers, qualifications, validations, and cross-functional collaboration. You will play a critical role in providing robust analytical support for biologics and gene therapy platforms, including nucleic acid and cell-based assays.

Responsibilities

+ Develop and execute analytical method lifecycle activities such as method transfers, qualifications, validations, and stability testing.

+ Engage in method lifecycle projects involving ddPCR, qPCR, nucleic acid purification/extraction, cell-based potency assays, and sub-visible particle analysis.

+ Create and maintain technical documents, including 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

+ 5 years of previous pharmaceutical experience with GMP.

+ Proficient in bioassay and method validation.

+ Experience with method transfer, cell culture, ELISA, ddPCR, and HPLC.

Additional Skills & Qualifications

+ Experience in transferring methods and ensuring their validation.

Work Environment

This role is based on-site in Durham at a start-up company with strong financial backing from Europe. As the company establishes its presence in the US, it offers a unique opportunity to be part of a growing team and contribute to exciting projects. The work environment is collaborative, dynamic, and offers a chance to be at the forefront of innovation.

Job Type & Location

This is a Contract position based out of Durham, NC.

Pay and Benefits

The pay range for this position is $48.00 - $50.00/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 Nov 14, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.