Associate Scientist

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