Associate Scientist

Net2Source (N2S); Seattle (WA); On-site; USD 62,000 - 66,000; Full time

Job summary

Net2Source Inc. is recruiting an Assistant/Associate Scientist for a 12-month contract in Seattle, WA to support cell therapy GMP manufacturing. The role focuses on testing, process improvements, and investigations to enable regulatory filings for material and process changes.

You will execute experiments, analyze data, and draft technical reports while collaborating cross-functionally in a fast-paced environment with opportunities to extend. Weekend or off-hour support may be required.

Qualifications

• Degree in Biological Sciences, Chemical/Biomedical Engineering, Life Sciences or related discipline.
• BS with 2+ years or MS with 0+ years in biologic process/analytical development or commercial biologic manufacturing process support.
• Excellent documentation skills and attention to detail with cGMP experience a plus.
• Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities.
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
• Excellent problem-solving skills.
• Able to creatively manage time and elevate relevant issues to project lead and line management.
• Strong scientific and technical writing with excellent oral communication skills.

Responsibilities

• Execute experiments in the process development labs including 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 turnaround 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.

Skills

Cell Therapy experience

Aseptic manufacturing or process dev

Data analysis experience

Cross-functional work

Fast-paced environment

Education

Biological Sciences

Chemical/Biomedical Engineering

Life Sciences or related

Tools

MS Office

R

JMP

Minitab

Job description

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.

Company: One of Our Clients

Job Description:

Job Title: Assistant/Associate Scientist

Location: Seattle, WA 98109

Duration: 12 Month Contract (Extendable)

Pay Rate range: $45.00 - 47.55/hr on W2

2 Openings

Top Skills-

• 1. Cell Therapy experience
• 2. Aseptic manufacturing or process development experience
• 3. Data analysis experience
• 4. Be able to work in a cross functional environment
• 5. Be able to work in fast-paced environment

Summary

The Assistant Scientist will play a key role in ensuring successful manufacture of life-saving cell therapy products. The primary focus of the Assistant Scientist will be to support testing and implementation of operational improvements and resolve manufacturing process investigations at the cell therapy GMP manufacturing facilities. The Assistant scientist 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. The Assistant Scientist will also contribute to well controlled comparability and validation studies which enable regulatory filings for raw material and process changes.

Primary 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

Required Qualifications:

• Degree in Biological Sciences, Chemical/Biomedical Engineering, Life Sciences or related discipline.
• 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.
• Excellent documentation skills and attention to detail with cGMP experience a plus.
• Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities.
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
• Excellent problem-solving skills.
• Able to creatively manage time and elevate relevant issues to project lead and line management.
• Strong scientific and technical writing with excellent oral communication skills.

Preferred Qualifications:

• Experience with cell therapy process development or manufacturing
• Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)
• Experience supporting investigations in support of commercial manufacturing
• Experience with commercial product support, i.e. post-marketing commitments, on-going validation and comparability
• Combination of experience in process development, MSAT and quality.
• Operational excellence training/background

Awards and Accolades:

• America's Most Honored Businesses (Top 10%)
• Awarded by USPAAC for the Fastest Growing Business in the US
• 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
• Fastest 50 by NJ Biz (2020, 2019, 2020)
• INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
• Top 100 by Dallas Business Journal (2020 and 2019)
• Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
• 2019 Spirit of Alliance Award by Agile1
• 2018 Best of the Best Platinum Award by Agile1
• 2018 TechServe Alliance Excellence Awards Winner
• 2017 Best of the Best Gold Award by Agile1(Act1 Group)