The Process Scientist or Process Engineer of Upstream Operations will be responsible for supporting the commissioning, startup, and routine operation of cell culture based upstream production equipment in a cGMP biopharmaceutical pilot plant. Once the facility is operational, the individual will provide technical expertise for upstream processes or systems supporting the manufacture of preclinical, phase I and phase II clinical materials including assisting in the transfer of new technologies/processes, operation and troubleshooting of cell culture bioreactors and harvest equipment, preparation and close-out of documentation, manufacture of upstream materials, and ensuring compliance to relevant regulations. The Process Scientist or Process Engineer will also participate in the implementation of process improvement strategies and evaluation of new technologies. The individual may lead a team supporting a campaign.
1. Provide hands-on execution in the operation of equipment to support preclinical, phase I and phase II clinical trials. Coordinate equipment maintenance, calibration, and validation with appropriate internal departments.
2. Provide support for the transfer of new processes and technologies working with R&D and the technology transfer laboratory personnel. Support process performance monitoring, operational excellence activities, and process improvement strategies.
3. Participate in the validation maintenance, re-qualification, and improvement of upstream production equipment. Participate in the design, implementation, and commissioning of new technologies for upstream manufacturing.
4. Prepare bill of materials, master batch records, SOPs, and close-out reports for each campaign.
5. Assist in troubleshooting product and equipment issues and deviations. Provide timely reporting, investigation, and resolution of manufacturing deviations, change control, and corrective and preventive actions.
6. Ensure adherence of operations to cGMP, ICH, EMEA and JP Guidelines as well as industry safety standards and OSHA guidelines.
7. Lead teams supporting a technology transfer and/or a campaign.
8. Interact cross-functionally with Downstream Operations, Support Operations, Facilities, R&D, Quality Assurance, Quality Control, Validation, and other internal and external functions to support successful product development.
BS, MS or PhD in chemical engineering or other engineering
Minimum of 7 yrs (BS), 5 yrs (MS), or 3 yrs (PhD) practical scientific experience
Minimum of 3-7 yrs in a multi-discipline cGMP environment, commissioning and running equipment in upstream production areas.
Knowledgeable in mammalian cell culture, upstream equipment operation, and CIP/SIP operations.
Knowledgeable in technology transfer, equipment validation and facility startup.
Ability to identify, investigate, and solve process and equipment problems.
Strong working knowledge of cGMP, EMEA, and JP regulations.
Excellent written and communication skills.
Excellent interpersonal skills.
Team player who can excel in a “hands-on” entrepreneurial environment