B100 Upstream Operations Manager – Night Shift

B100 Upstream Operations Manager – Night Shift

Requirements

• Minimum Bachelors in Microbiology/Biochemistry/Chemical Engineering or related Life Science(s)​.
• Preferred Masters in Microbiology/Biochemistry/Chemical Engineering or related Life Science(s).
• At least 3-5 years of experience in pharmaceutical industry/manufacturing (people management experience preferred).

Responsibilities

• Supports the design of B100 relevant operations through remaining stages of project
• Review and approve technical and quality related documentation.
• Administration of Miscellaneous equipment (user access, periodic review, audit trail management)
• Development and ownership of production schedules to support validation, engineering runs and full scale manufacturing
• Manages scheduling of preventative maintenance plans, spare parts, BOMs.
• Supports development of manufacturing recipes
• Supports execution of validation activities related to equipment, process and facilities
• Ensures project support and production activities are executed as per defined schedules
• Monitors & communicates team performance with respect to deliverables using visible metrics
• Supports operations execution on the shop floor (MES, PCS)
• Responsible for development and life cycle management of documentation related to manufacturing operations (eBPR, Logs, etc)
• Supports development of operating budget and staffing for operations and project related activities.
• Develop communication approach for operations topics to ensure project milestones are met (escalation, cascading)
• Works with QOOQ, QOSA and RA to ensure compliance with GMP requirements, develop quality continuous improvement initiatives, develop staff quality culture and GMP knowledge
• Leads development and maintenance of operating procedures in adherence to global and site policies
• Ensures compliance of facilities & equipment; minimize process deviations and environmental incidences, identify root cause and implement corrective/preventative actions.
• Supports the development of lesson plans, ensure training is completed in a timely manner. Ensure lesson plans are updated appropriately and training remains current.
• Conducts inspections for manufacturing operations (GEMBA, MSV)
• Point of contact (lead) for internal/external audits, regulatory inspections, regulatory responses
• Organizes and develops staff to ensure a high performing team; establishes, monitors and provides individual feedback on staff objectives; ensures training of staff according to training plans and to continue to develop their competencies; coach staff on personal development goals and document follow up
• Contributes to the B100 management team, communicates and co-operates with other departments to obtain consensus and ensure appropriate service levels
• Hire new employees and follow company’s procedures; responsible for attendance management and time reporting system.
• Implement and execute lean management systems established for Bulk; ensures continuous improvement of processes; troubleshoot and lead resolution for manufacturing issues
• Identify and lead initiatives to increase process efficiency, quality and/or yield; implements solutions or changes via change control; plans and manages facility and organization improvements
• Provides metrics and other reports as requested
• Ensures that employees work within the policies, procedures and regulations including responding promptly to all health and safety concerns or incidents
• Ensures all critical incidents and accidents are reported to the appropriate authorities; potential safety and health hazards are identified communicated to staff as lessons learned
• Ensures that that personal protective equipment and clothing are available and appropriate for the tasks
• Ensures continuous EHS awareness and improvement by integrating team with site and Bulk initiatives
• Cooperation with and assistance to the EHS management and Joint Health and Safety Committee in carrying out their functions.

Preferred Qualifications

• Preferred Masters in Microbiology/Biochemistry/Chemical Engineering or related Life Science(s).
• People management experience preferred.