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