Capital Associated Industries, Inc.
  • Princeton, NJ, USA
  • Full Time

Founded in Lyon, France in 2004, ERYTECH is a clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseases. 

Placing the patient at the heart of our priorities, demonstrating ethics and respect towards each person, Erytech is focused on becoming a global leader in rare cancer and orphan diseases space.

Since our inception, our mission has been to make a sustained investment in R&D in order to meet the challenges of public health and to offer innovative therapies to target markets with high unmet medical needs, particularly in the field of cancer.

Our company has been classified as a Pharmaceutical Facility and develops its activities in close collaboration with health professionals, particularly physicians and pharmacists.

The successful candidate must be able to manufacture human blood derived oncology drugs per Standard Operating Procedures in a controlled cleanroom environment. Ensures all manufacturing activities are performed under cGMP guide lines. Communicates production deviations/incidents to the supervisor/Manager as soon as it is discovered.

DUTIES

  • Ensures all training requirements are completed according to Erytech training guidelines.
  • Perform all manufacturing activities according to cGMP guide lines.
  • Record all manufacturing activities in the batch record and Erycaps machine according to the SOP.ng
  • Communicate all deviations to immediate supervisor or manager prior to moving to the next step.
  • Be able to work overlapping shifts if needed
  • Assist in reviewing SOP's and Batch records as needed
  • Attend at least one or two GMP meetings per year

       Working Environment:

  • Clean room environment, flexibility to don cleanroom garments and personal protective equipment
  • Routine exposure to human blood components
  • Flexible working hours

QUALIFICATIONS

  • **Bachelor's degree in Biological sciences plus 3-4 years of Manufacturing experience in the Biotech industry, working with Oncology drugs will be a plus!
  • Understanding of aseptic processing in a GMP environment
  • Knowledge of CGMP/FDA regulated industry
  • Basic mathematical skills
  • Proficient in MS Office applications
  • Understanding of Biology, Chemistry, Medical or Clinical Practices
  • Previous experience in manufacturing is a plus
  • Current Pasport is a plus!
Capital Associated Industries, Inc.
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