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 will supervise QC lab daily functions including raw material, In process and final product testing and QC release flow.  Supervise QC lab analyst and review data. 

DUTIES

  • Strong understanding of cGMPs is a must, applicable best practices, and regulatory guidance's.
  • Strong cGMP documentation skills.
  • Blood Borne Pathogen Training.
  • Excellent constructive communication skills, highly motivated with strong work ethic
  • Travel for training and off-site instrument/method troubleshooting activities.
  • Supervisory experience preferred. 

QUALIFICATIONS

Minimum Bachelor of Science

Experiences:

  • Minimum 5 years of analytical/bioassay testing in a cGMP quality control lab for Biologics.
  • Schedule sample testing flow in QC lab. Supervise QC lab analyst.
  • Supervise/execute method validation, instrument qualification and stability studies.
  • Supervise/execute instrument and method troubleshooting activities.
  • Execute Test Methods
  • Review Raw Material release, In-process and final product test data.
  • Author Reports and SOP.
  • Strong Deviation and OOS Investigation documentation experience.
  • Experience in Lab audits. Hands On Work!!
Capital Associated Industries, Inc.
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