Associate Scientist, Cell Therapy Manufacturing Support (Onsite – Seattle, WA)

We are seeking an Associate Scientist, Cell Therapy Manufacturing Support for a global pharmaceutical client. The focus of the role is to ensure successful manufacture of life-saving cell therapy products and to support testing and implementation of operational improvements and resolve manufacturing process investigations at the client’s cell therapy GMP manufacturing facilities. You will be part of a team tasked with completing manufacturing support studies, including investigational, process improvement and process characterization studies. This individual will primarily execute experiments, evaluate data, and draft technical reports.  You will also contribute to well controlled comparability and validation studies which enable regulatory filings for raw material and process changes.

This is a 40-hour per-week, 12-month contract (extensions possible), 100% onsite role in Seattle, WA.

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

Responsibilities:

• Execute experiments in the process development labs which includes aseptic processing and operation of automated process equipment. 

• Summarize experimental data and aid in analysis to draw conclusions. 

• Coordinate with the analytical group for timely delivery of process samples and turn-around of analytical data.  

• Support production-related investigations, ensuring compliance with internal standards and regulatory requirements. 

• Develop and execute manufacturing process changes and improvement activities, and/or author technical reports for process changes and improvements. 

• Support process comparability and process validation studies including planning, execution, and documentation management. Support necessary technical experiments and analysis to enable decisions related to raw materials changes. 

• Flexibility with work schedule as maintenance of cell cultures on occasional weekends, early mornings, or evenings is required 

Requirements:

• BS degree with minimum of 2+ years of relevant experience, or MS degree with minimum 0+ years of relevant experience in biologic process/analytical development or commercial biologic manufacturing process support. 

• Experience with cell therapy process development or manufacturing 

• Aseptic manufacturing or process development experience

• Data analysis experience - Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab) 

• Excellent documentation skills and attention to detail with cGMP experience a plus.  

• Strong scientific and technical writing with excellent oral communication skills.

• Experience supporting investigations in support of commercial manufacturing is preferred

• Experience with commercial product support, i.e. post-marketing commitments, on-going validation and comparability is preferred

• Combination of experience in process development, MSAT and quality is preferred

• Operational excellence training/background is preferred   

• Degree in Biological Sciences, Chemical/Biomedical Engineering, Life Sciences or related discipline. 
 

Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Associate Scientist, Cell Therapy Manufacturing Support (Onsite – Seattle, WA) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $45/hr. - $47.55/hr.

#LI-SW1