Job Title: Quality - Downstream Associate Scientist
Location: King of Prussia, PA 19406
Duration: One year from start date, with possible extension to 18 months total
WORK SHIFT = 1st shift standard day shift (i.e. Mon-Fri; 40 hrs/wk; 8 hrs/day; 7:30 AM – 4:00 PM)
with early morning/evening and weekend work required occasionally, as needed
100% ON SITE
Top Skills for Candidate:
- Ability to work in highly matrixed organization.
- Ability to multi-task within a multi-functional team environment.
- Able to troubleshoot.
- Capable of following written instructions and have clear written communication skills as well as computer literacy.
- Familiar with basic scientific principles and have experience in routine bench work and/or instrumental analysis.
- Ability to author, revise and/or support SOP's, change controls, deviations
MEDICAL SCREENINGS:
- PAPR screening will be required after hire & will require completion of US Medical Clearance/Surveillance needed for CW to be completed for Respirator Use (Non-SCBA (OSHA regulated)
Basic Qualifications:
- Bachelor of Science degree in Chemical Engineering, Biology, Chemistry, or other engineering or scientific field.
- Familiarity with protein purification process operations and Good Manufacturing Practices (GMP) regulations.
- No experience required
Preferred Qualifications:
- Bachelor of Science degree in Chemical Engineering, Biology, Chemistry, or other engineering or scientific field with 1+ years of direct purification experience in a Pilot Plant or manufacturing setting.
- 1+ years of cGMP experience
- Knowledge of cGMP guidelines and standards.
- Knowledgeable of: Cytiva platform of purification equipment and Unicorn software
- Proficiency in executing standard procedures required in addition to some non-routine work.
Summary & Key Words:
- Preparation of buffer solutions, chromatographic separation, filtration and concentration operation, etc.
- Completing daily manufacturing tasks per standard operating procedures and batch document instructions.
- Documenting all manufacturing activities clearly and accurately.
- Ensures all production activities are completed in a safe and compliant manor. Maintain and prepare high quality documentation. Dispense large and small amounts of raw materials Perform CIP and SIP of product tanks
- Work with hazardous materials under the appropriate safety procedures
- Performs other functions as necessary or as assigned.
- Preparation of buffer solutions, chromatographic separation, filtration and concentration operation, etc.
- Completing daily manufacturing tasks per standard operating procedures and batch document instructions.
- Documenting all manufacturing activities clearly and accurately.
- Ensures all production activities are completed in a safe and compliant manor. Maintain and prepare high quality documentation. Dispense large and small amounts of raw materials Perform CIP and SIP of product tanks
- Work with hazardous materials under the appropriate safety procedures
- Performs other functions as necessary or as assigned.
Education:
Bachelor of Science degree in Chemical Engineering, Biology, Chemistry
