Job Description:

Our client in Redmond is seeking a highly motivated individual who desires a significant opportunity to improve worldwide access to biotherapeutics. The QC Senior Scientist/Scientist will provide oversight in a fast paced, collaborative QC Analytical laboratory that supports GMP testing of clinical biological products. In addition to performing product testing, the Senior Scientist/Scientist will provide oversight on project teams for both internal and client interactions and will author GMP documents such as SOPs, specifications, stability protocols, and method validation protocols and reports. The staff member will assist with the oversight of the daily laboratory operations and manage a small group of QC scientists. The successful candidate will have extensive laboratory compliance experience, exceptional attention to detail and have experience designing and implementing laboratory efficiency improvements.

Responsibilities:

Conduct analytical testing and provide hands on training to staff.Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT and team milestones are achieved.Provide subject matter expertise during internal project team meetings and interactions with clients.Provide expertise for the IOPQ of laboratory instrumentation, analytical equipment troubleshooting and routine equipment maintenance.Author stability summary reports, product specifications, stability protocols, SOPs, guidance documents and analytical methods.Provide technical support during analytical method transfer into the QC laboratory.Identify gaps, design collaborative solutions, and implement laboratory improvements.Oversee laboratory investigations, deviations, OOS, and CAPAs.

Required Qualifications:

Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA) as they relate to drug substance biological manufacturing and release / stability testing.Extensive knowledge of GdPs, GMPs and DS / DP multi-compendial assays (USP, EP, JP).Understanding of biologics manufacturing processes.Excellent communication and collaboration skills.Experience with the operation, deployment, and administration of laboratory information management systems (LIMS).Proficient with Waters Empower, Sciex 32 Karat and Microsoft Office applications (Word, Excel).Experience with Waters HPLC, UPLC and Beckman PA800 CE systems.Experience with ELISA based impurity or potency methods.Method validation experience.Attention to detail and highly organized.BS in Biochemistry, Chemistry or related field with 8-12 years of experience and a minimum of 5 years of hands-on experience in a cGMP compliant laboratory.

Pay and Benefits

The pay range for this position is $55.00 - $65.00

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 Seattle,WA.

Application Deadline

This position will be accepting applications until Jan 3, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

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.