Scientist

The Analytical Method Lifecycle Specialist plays a critical role on the Bioassay team, providing site-wide analytical and quality support for biologics and gene therapy platforms. This position focuses on method transfers, qualifications, validations, and stability testing, ensuring robust and compliant nucleic acid and cell-based assays in a fast-growing, startup CDMO environment.

Responsibilities

• Plan, lead, and execute analytical method lifecycle activities, including method transfers, qualifications, validations, and stability testing for biologics and gene therapy assays.
• Work on method lifecycle projects involving HPLC, ensuring methods are appropriately developed, transferred, and validated for routine use.
• Draft, review, and maintain technical documents such as protocols, standard operating procedures (SOPs), and technical reports to support regulatory and operational compliance in a GMP setting.
• Support routine and investigational stability testing protocols, generating accurate, timely data and ensuring proper documentation and data integrity.
• Train and mentor junior QC analysts to ensure consistent execution of analytical procedures and adherence to method lifecycle requirements.
• Conduct root cause analysis for out-of-specification (OOS) and out-of-trend (OOT) results, contributing to continuous improvement initiatives and corrective and preventive action (CAPA) implementation.
• Collaborate with internal and external stakeholders to ensure phase-appropriate testing strategies, data trending, and technical reporting aligned with regulatory expectations.
• Contribute to cross-functional quality initiatives that strengthen site-wide analytical capabilities for nucleic acid and cell-based platforms.
• Ensure all analytical activities comply with GMP requirements and support successful regulatory inspections and client audits.

• Strong experience working in a GMP pharmaceutical environment, with approximately 5 years of previous industry experience.
• Hands-on expertise with HPLC, including method development, transfer, qualification, and validation.
• Proven experience executing method validation and method transfer activities in a regulated laboratory setting.
• Demonstrated ability to write and review protocols and other technical documents in a GMP environment, specifically related to transferring and validating analytical methods.
• Solid understanding of analytical method lifecycle principles, including stability testing and data trending.
• Ability to conduct root cause analysis for OOS/OOT investigations and support CAPA implementation.
• Experience training and mentoring junior analysts on analytical procedures and GMP practices.
• Strong technical writing skills for drafting SOPs, protocols, and technical reports.
• Working knowledge of chemistry and bioanalytical techniques relevant to nucleic acid and cell-based assays.

• Experience supporting analytical activities for biologics and gene therapy platforms.
• Background in nucleic acid and cell-based assay development or testing.
• Comfort working in a fast-paced, startup environment with evolving processes and client needs.
• Ability to collaborate effectively with cross-functional teams and external partners.
• Strong attention to detail and commitment to data integrity and regulatory compliance.

This role is based on-site in Durham within a dynamic startup CDMO environment that is rapidly expanding its presence in the United States. The facility focuses on advanced biologics and gene therapy platforms and is equipped to support HPLC-based analytical methods and GMP-compliant operations. Team members work closely with clients on a variety of innovative projects, contributing to the build-out of new capabilities and infrastructure. The culture emphasizes collaboration, growth, and the opportunity to shape processes and practices from the ground up, supported by strong financial backing and a pipeline of exciting customer inquiries.

Job Type & Location

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

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)

This is a fully onsite position in Durham,NC.

This position is anticipated to close on Jun 30, 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.

Salary : $51