REQUIREMENTS:

• Bachelor’s degree in biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
• 4 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components). Position level will scale with experience level of candidate.
• Competent in analyzing complex situations and show practical problem-solving capabilities.
• Ability to work independently and within a cross-functional team.
• Understanding of multi column chromatography concepts
• Familiarity with contamination control and batch release requirements
• Experience leading, presenting, or supporting Regulatory Inspections and Site Internal Audits
• Problem, Deviation, and Change Management experience

Reporting to the Process Operations Lead the Operations Specialist will support end-to end production operations for both Fed Batch and Continuous Manufacturing

Primary activities/responsibilities:

• Lead/Guide team members within the Production Operations team
• Coach and develop colleagues within the Production team
• Support team on shift cycle and act as POC (point of contact) and POE (point of escalation) to ensure effective issue resolution
• Lead, facilitate and participate in cross-functional teams to collaborate effectively to cover compliance topics.
• Responsible for monitoring operational performance, follow-up on any significant adverse trends for the identification and implementation of operational optimization, and robustness improvement projects.
• Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
• A Change and QRA Champion within the organization and site, to bring about new technologies, digitization, and identify opportunities to bring new ways of working.
• Lead complex process investigations on the production floor in support of deviation resolution.
• Use the extensive operational experience to mentor new members of staff in specific plant activities when required and as a key point of contact for external groups
• Support team on 24/7 shift cycle and act as POC (point of contact) and POE (point of escalation) to ensure issue resolution
• Conduct all work activities with a strict adherence to the safety and compliance culture on site
• Participate in safety, process and environmental investigations. Review alert and action limits as needed and implement corrective action as appropriate
• Write, review, and/or approve manufacturing documentation (SOPs, Manufacturing Records & Logbooks)
• Ensure the effective use of material, equipment and personnel in producing quality products.