Clinical & Network Enablement Business Analyst

Description

• Must be able to gown into cleanroom environment and be standing for ~1-2 hours at a time. • Must be able to manipulate screw-cap vials inside a BSC and aseptically fill at least 200 vials in a single setting. • Must have practical knowledge of the use of Personal Protective Equipment (PPE) to handle hazardous materials throughout site. • Must be able to gracefully manage non-ideal situations under stress. • Must have a change-agile growth mindset for navigating changing needs and priorities. Hard Skills: 1. Knowledge of mammalian cell culture and/or microbial fermentation processes. 2. Operational knowledge of computerized systems. 3. Ability to follow Standard Operating Procedures and work under minimal supervision. Soft Skills: 1. Communication (Oral, Written) 2. Prior experience in a Biological Pilot Plant, cGMP Clinical or Commercial Manufacturing setting. 3. Familiarity with business systems (e.g. Document Management Systems, LIMS, electronic Notebook, etc.) 4. Experience in mammalian and microbial cell culture in a GMP setting with strong aseptic technique. 5. Experience in cGMP compliance and regulatory compliance requirements as related to manufacture of biologics. Interview Process: 1st Teams Bridge Phone interview 2nd Panel Teams (camera on) Position Comments visible to Supplier:Please be sure to review the entire JD along with PHYSICAL POSITION REQUIREMENTS