QC Chemist

Job Title: QC Chemist

Job Description

The QC Chemist serves as a Method Transfer Lead (MTL) and a QC expert within the QCSV group. This role involves a significant understanding of analytical method transfer and/or validation to ensure compliance with cGMP and regulatory expectations. As an individual contributor, you will play a crucial role in supporting the method transfer and validation processes both internally and externally.

Responsibilities

• Support the Project Lead for method transfer and/or validation for assigned programs.
• Author or review protocols and reports for method transfer, validation, and bridging, as well as other technical development reports.
• Plan and track deliverables related to method transfer and validation.
• Collaborate and interact with internal and external QC testing sites, project leads, and functional representatives.
• Review method transfer and validation assays, perform data verification, non-routine data mining, and in-depth data analysis.
• Represent QC in intra-departmental projects or cross-functional teams to support program and company goals.

Essential Skills

• Expertise in designing and evaluating method validation and transfer studies, including partial re-validation, co-validation, and cross-validation approaches.
• Strong technical writing skills for authoring methods, validation, and transfer studies/protocols/reports.
• Expert knowledge of scientific principles and experience with mAb, ADC, vaccine, and gene therapy studies.
• Proficiency in analytical methods and plate-based methods, with preference for experience in analytical separation methods (SEC, icIEF, CE-SDS).
• Good project management skills with the ability to manage multiple projects simultaneously.
• Strong data interpretation and method troubleshooting skills, along with sound scientific judgment.
• Excellent time management skills with attention to detail and a desire to achieve team and individual goals.
• Effective communication skills to lead teams and influence cross-functional team members.
• Understanding of regulatory guidance and requirements (ICH, CFR) pertaining to method transfer, validation, and submissions such as IND, IMPD, BLA, or NDA.

Additional Skills & Qualifications

• Bachelor’s degree in life science, such as analytical chemistry, biology, biochemistry, pharmaceutical science, or a related technical discipline.
• 8-10 years of relevant experience in pharmaceutical/biological drug product development, analytical chemistry, and/or QC in a regulated biotechnology or pharmaceutical company.

This is a Contract position based out of Bothell, WA.

The pay range for this position is $40.00 - $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)

This is a fully onsite position in Bothell,WA.

This position is anticipated to close on Feb 16, 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 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 actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $40 - $50