Proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)
Minimum of a Bachelor's or equivalent University Degree required
Experience with aseptic processing in biosafety cabinets and/or ISO 5 clean room
Demonstrated experience successfully working in an analyst role/level and proficiency using analytical methodologies within a functional laboratory
Requires up to 5% domestic travel to other sites/locations
Experience within Biopharmaceutical or Pharmaceutical industry
Advanced degree (MSc., Ph.D.) or focused degree in Biology, Biochemistry, Chemistry, or related scientific field is preferred
Excellent written and verbal communication skills
Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays
Minimum of two (2) years of relevant work experience
Experience with Quality Control document reviews and regulatory inspection processes
Requires the ability to meet the physical demands (lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting), to perform visual inspections of materials (color, appearance, particles, etc.), and to document observations during laboratory testing
Knowledge of cGMP regulations and Good Documentation Practices (GDP)
Requires ability and flexibility to work 10-hour shifts between the operational hours of 4:00pm - 2:00am (Sunday - Wednesday), and provide occasional support on the weekends or other shifts