Downstream Process Associate

1 week ago


King of Prussia, Pennsylvania, United States Alphanumeric Systems Inc. Full time
About the Role

We are seeking a highly skilled Downstream Associate Scientist to join our team at Alphanumeric Systems Inc. in Upper Merion, PA. As a key member of our organization, you will be responsible for the preparation of buffer solutions, chromatographic separation, filtration, and concentration operations.

Key Responsibilities
  • Prepare buffer solutions, chromatographic separation, filtration, and concentration operations
  • Complete daily manufacturing tasks per standard operating procedures and batch document instructions
  • Document all manufacturing activities clearly and accurately
  • Ensure all production activities are completed in a safe and compliant manner
  • 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
  • Perform other functions as necessary or as assigned
Requirements
  • 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 is 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
  • Ability to work in a 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 SOPs, change controls, and deviations


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