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Direct Hire - Process Associate II, Downstream Development & Operations
Ref No.: 18-18659
Location: Woodcliff Lake, Pennsylvania
Job Title: Process Associate II – Downstream Development & Operations
Location: Woodcliff Lake, NJ 07677
Position Type: Dire Hire - Permanent

Description:
  • Participate in the routine operation of purification and formulation production equipment supporting the execution of GMP campaigns to produce clinical trial materials.
  • In addition, participate in the design and implementation of new processes, equipment and technologies for downstream manufacturing. Participation in other areas within the facility may be added at the company's discretion.
  • Work in a hands-on capacity in the operation of downstream equipment for the manufacture of Work in a hands-on capacity in the operation of downstream equipment for the manufacture of preclinical and phase I - III clinical trial materials. Assist in the coordination of equipment maintenance, calibration, and (re)validation with appropriate internal departments.
  • Provide cross-functional support for other operational departments within the pilot plant at the discretion of management.
  • Provide support for the development, transfer and scale-up of new processes and technologies working with R&D and the technology transfer laboratory personnel. Support process performance monitoring, operational excellence activities, and assist in the implementation of process improvement strategies.
  • Assist in the preparation of bill of materials, batch records, SOPs, technical reports and campaign summaries.
  • Ensure adherence of operations to cGMP, ICH, EMEA and JP Guidelines as well as industry safety standards and OSHA guidelines.
  • Assist in troubleshooting downstream production issues, deviations and process/equipment investigations.
  • Interact cross-functionally with Upstream Operations, Support Operations, Facilities, R&D, Quality Assurance, Quality Control, Validation, and other internal and external functions to support successful product development.


Job Qualifications:
  • BS or MS in Biological Sciences or Engineering or equivalent job experience/degree is strongly preferred.
  • Minimum of 3-5 yrs (BS) or 1-3 yrs (MS) in a multi-discipline cGMP environment, commissioning and operating equipment in downstream production areas.
  • Proficient in the operation of all area-specific production equipment such as chromatography columns and controllers, TFF skids, viral filtration technologies and CIP/SIP operations.
  • Experience in process development, technology transfer, scale-up, equipment validation and viral clearance studies.
  • Ability to identify, investigate, and trouble-shoot basic process and equipment problems.
  • Working knowledge of cGMP, EMEA, and JP regulations.
  • Good written and communication skills.
  • Good problem solving and interpersonal skills with the ability to work in a team environment required.
  • Must Haves: Chromatography (any) , science background preferred, filtration experience