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Supervisor, Biologics Manufacturing Downstream

The Downstream Supervisor leads and drives the execution of commercial manufacturing processes according to established electronic work instructions and production records for the manufacture of therapeutic proteins in accordance with Current Good Manufacturing Practices (cGMP's). The Supervisor is responsible for management of group whose primary focus is on execution of manufacturing processes, technical assessment of processes, maintaining a culture of compliance, innovation, and within their functional group. The Supervisor is required to guide the personnel in their group with knowledge and technical knowledge to lead troubleshooting activities, provide investigation support, analyze process/equipment data, and identify and implement process improvements.
Responsibilities:
Provides direct oversight of the execution of manufacturing unit operations. These operations include but are not limited to the use of the following equipment and or systems: i.e. CIP systems, bioreactors, chromatography systems, media/buffer preparation equipment etc.), process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and supporting business systems (i.e. SAP. Trackwise, Maximo etc.).
Drives right first time (RFT) execution of manufacturing unit operations by providing direct training, guidance, and problem solving on the floor in real time.
Responsible for the implementation and execution of Standard Work in all functional areas.
Takes an active role in selecting and developing the team. This includes leveraging both internal and external relationships to build the best team possible.
Takes an active role in developing less experienced Technical Leads.
Ensures team adherence to Good Manufacturing Practices and standard operating procedures.
Ensures daily work coordination and distribution as demanded through the manufacturing schedule.
Is responsible for maintaining schedule adherence and cycle time.
Reports variances and communicates impact to cross functional groups.
Manage daily communication to shift personnel.
Supports and drives shift huddles and functional team meetings.
Provides shift handover and Tier communication working with other shift team members.
Ensures oversight for critical operations through systematic walk down and checks of equipment and functional areas prior to execution.
Review critical attributes and drive decisions.
Act as an area/system owner ? a point of contact for all work to be carried out for the area over assigned shift.
Build partnership with Manufacturing Operational Engineer to ensure daily data review and trends accomplished.
Provide critical communications upwards, downward and across as deemed fit.
Manage decisions? acquire feedback, input, and consult as required.
Ensure shift notes communication is complete and accurate.
Provide critical update summary to the staff for all safety incidents and significant process deviations.
Manages performance. Provide coaching, mentoring and development of staff. Conducts powerful conversations and provides meaningful and actionable feedback for staff growth and development. Executes all phases of the performance review process with diligence and on time. Drives continuous improvements through staff engagement
Demonstrates the ability to lead manufacturing operations teams to achieve objectives.
Acts to promote a productive and cooperative climate.
Helps to promote team effectiveness by engaging in a trusting, supportive partnership with others.
Encourages or facilitates a beneficial resolution of purpose.
Resolve conflicts in a constructive manner that allows win/win solution.
Effectively controls the controllable expenses (OT, Supplies, T&E) within their influence.
Owns and executes OpEx initiatives including 5S.
Owns all level 3 investigations occurring on their shift as Lead Investigator.
Participates as a team member on level 1 and 2 investigations driving and executing appropriate CAPAs.
Acts as the emergency lead for functional area while on shift.
Provides direct audit support.
Acts as a consultant to project teams.



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