SOKOL GxP Services
cell therapy
Assistant/AssociateScientist
Neural analysis suggests this role is
optimal for Entry candidates.
“Assistant/Associate Scientist at SOKOL GxP Services. Skills: cell therapy, process development, manufacturing, GMP, validation, investigations. support testing and implementation of operational improvements. resolve manufacturing process investigations”
What You'll Achieve.
ensuring successful manufacture of life-saving cell therapy products; enable regulatory filings for raw material and process changes
Industry & Context.
Excellent problem-solving skills; resolve manufacturing process investigations; support production related investigations; support necessary technical experiments and analysis
maintenance of cell cultures on occasional weekends, early mornings, or evenings is required
What They're Looking For.
Must Have
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, 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., scientific and technical writing with excellent oral communication skills.
Nice to Have
cGMP experience, Experience with cell therapy process development or manufacturing, Proficiency utilizing MS Office products, 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 trainingackground
What You'll Do.
support testing and implementation of operational improvements
resolve manufacturing process investigations
completing manufacturing support studies
including investigational
process improvement and process characterization studies
draft technical reports
contribute to well controlled comparability and validation studies which enable regulatory filings for raw material and process changes
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
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
or evenings is required
How You'll Work.
Team & Collaboration
Ability to effectively work in cross functional teams; Coordinate with the analytical group
Communication Scope
excellent oral communication skills
Process & Methodology
prioritize responsibilities, planning, execution, documentation management
Full Job Description
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 BMS 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 **Requirements** **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 minimu
Applying for this Assistant/Associate Scientist role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
ANONYMOUS · UNFILTERED
What do employees actually say about SOKOL GxP Services?
Real rants from real employees. Read before you apply.