Assistant/Associate Scientist – Cell Therapy Process Development
Location: Seattle, WA (100% Onsite)
Duration: 12 months Contract + potential extensions
Pay Range: $40-$47/hr on W2 (Based on Experience)
About TSR
TSR is a trusted staffing and workforce solutions partner with more than 50 years of experience delivering highly qualified talent to support clients' most critical business and technology initiatives. Through a disciplined approach to sourcing, candidate vetting, and talent engagement, TSR is committed to connecting exceptional professionals with industry-leading organizations.
Position Summary
TSR is seeking an Assistant/Associate Scientist for a leading pharmaceutical client in Seattle, WA. This role will support the successful manufacture of cell therapy products by executing studies that drive operational improvements and resolve manufacturing process investigations within GMP facilities.
The ideal candidate is a hands‑on laboratory scientist with experience in aseptic processing, GMP/GLP practices, biologic process development, or commercial biologic manufacturing support. The role will involve executing experiments, analyzing data, preparing technical documentation, and supporting process comparability and validation studies.
Key Responsibilities
- Execute experiments in process development laboratories, including aseptic processing and operation of automated process equipment.
- Summarize experimental data and support analysis to draw scientific conclusions.
- Coordinate with analytical teams to ensure timely process sample delivery and analytical data turnaround.
- Support production-related investigations in compliance with internal standards and regulatory requirements.
- Develop and execute manufacturing process changes and improvements.
- Author and maintain technical documentation, including protocols, reports, and SOPs.
- Support process comparability and validation studies, including planning, execution, and documentation.
- Perform technical experiments and analyses to support decisions related to raw material changes.
- Collaborate with cross‑functional teams in a fast‑paced environment to meet project timelines and team goals.
- Follow GMP/GLP procedures, SOPs, and applicable regulatory requirements while maintaining data integrity and quality.
- Provide occasional flexibility for cell culture maintenance during early mornings, evenings, or weekends as needed.
Required Qualifications
- Bachelor's degree in Biological Sciences, Chemical Engineering, Biomedical Engineering, Life Sciences, or a related scientific discipline with 2+ years of relevant experience.
- OR Master's degree with 0+ years of experience in biologic process development, analytical development, or commercial biologic manufacturing process support.
- Hands‑on experience with aseptic technique.
- Experience working in a GMP/GLP laboratory environment.
- Strong technical writing skills, including experience drafting SOPs, protocols, technical reports, or related documentation.
- Strong problem‑solving, critical‑thinking, organizational, and time‑management skills.
- Ability to work effectively in cross‑functional teams and manage multiple priorities while meeting deadlines.
- Strong attention to detail and commitment to data quality and integrity.
Preferred Qualifications
- Experience in cell therapy process development or manufacturing.
- Experience supporting commercial manufacturing investigations.
- Experience with process validation and comparability studies.
- Background spanning process development, MSAT, and/or Quality.
- Experience with raw material changes and associated technical assessments.
- Experience with statistical/data analysis tools such as R, JMP, or Minitab.
- Proficiency with Microsoft Office.
- Operational excellence or continuous improvement training is a plus.
Top Skills
Technical Skills
- GMP / cGMP / GLP
- Cell Therapy / Cell Culture
- Biologic Process Development
- MSAT / Manufacturing Process Support
- Manufacturing Investigations
- Technical Writing / SOPs / Protocols / Reports
- R, JMP, or Minitab
Soft Skills
- Strong Problem‑Solving & Critical Thinking
- Excellent Attention to Detail
- Cross‑Functional Collaboration
- Strong Communication Skills
- Time Management & Organization
- Ability to Work Independently in a Fast‑Paced Environment