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Manager, Commerical Manufacturing, Downstream, 2nd Shift

The Shift Supervisor/Manager 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 Shift Supervisor/Manager 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 Shift Supervisor/Manger 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:
Drives site schedule by prioritizing resources/activities for manufacturing and support functions. Achieves schedule adherence and cycle time.
Leads one or more operational groups, ensuing department goals and metrics are meeting or exceeding expectations. Identifies opportunities and executes action plans to realize meaningful and lasting improvements.
Acts as manager of people managers - empowered to make and manage strategic personnel and technical decisions that directly impact manufacturing performance
Leads manufacturing operations teams to achieve department and site objectives. Acts to promote a productive and cooperative working environment, which maximizes team effectiveness by engaging in a trusting, supportive partnership with others. Encourages or facilitates a beneficial resolution of purpose. Resolves conflicts in a constructive manner that allows for mutually beneficial solutions. Able to effectively lead cross functional teams.
Develops stretch goals and uses effective motivation techniques to achieve them. Influences site goals and policies.
Takes an active role in developing Supervisors and Technical leads, leveraging both internal and external relationships to build the best team possible. Takes accountability for development and performance of all team members.
Manages team performance. Demonstrates passion for coaching, mentoring and development of staff. Provides meaningful and actionable feedback for staff growth and development. Serves as trusted leader within Manufacturing and beyond
Leads response to any developing issues and escalates as appropriate. Initiates response team for critical issues, managing team progress and providing detailed communication upwards, downwards and across.
Ensures team adherence to Good Manufacturing Practices and standard operating procedures.
Ensures daily work coordination and distribution of work as demanded through the manufacturing schedule.
Drives continuous improvements through staff engagement, project identification, prioritization and sponsorship
Demonstrated ability to prioritize and coordinate activities within and across work groups; able to anticipate priority differences and issues and resolves these before problems occur, exceeds desired results.
Participates in the budget development process; effectively managing controllable expenses (OT, Supplies, T&E) within their influence.
Provides shift continuity by attending the daily scheduling and triage meetings. Attends weekly planning meetings as a standing member.
Provides direct audit support.
Provides on call support for the manufacturing team including active participation on the weekend calls.
Knowledge/Skill:
Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
Direct biologic manufacturing experience of 8+ years with minimum of 3+ years of previous supervisory experience which demonstrates proficiency in selection of team and effectively managing personnel issues is required.
Mastery of SOPs and cGMPs and the know?how to work and manage within a regulatory environment.
Extensive knowledge of pharmaceutical and biopharmaceutical manufacturing process with a proven record in pharmaceutical technology, technology transfer, process development, manufacturing support.
Demonstrated aptitude for engineering principles and manufacturing automation systems.
Previous cross-functional supervisory experience which demonstrates proficiency in selection, motivating and retaining a superior team, effectively managing personnel issues and planning and administering financial resources.
Adaptable to a fast paced, complex and ever changing business environment.
Effective communication and technical writing skills with support groups in the coordinating system to obtain needed cooperation and support as required in a timely and effectively manner.



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