Drug Substance Production Supervisor

GSK•Marietta, PA

3d•Onsite

About The Position

You will lead day-to-day manufacturing operations in the Drug Substance (DS) area and be responsible for the timely, cost-effective, safe, compliant, and reliable delivery of a Drug Substance to customers. Supervise a team to ensure that safety, quality, compliance, and delivery targets for commercial product manufacturing are achieved. This role is responsible for making sure that all manufacturing operations are executed in a cGMP-compliant manner and in alignment with company standards. You will manage staff training and qualifications so operating procedures are consistently followed. Develop, supervise, lead, and motivate a multi-disciplinary team. As a member of the Manufacturing leadership team, contribute to departmental and site objectives while maintaining a strong customer focus. You will guide a team of technicians to deliver safe, compliant, and reliable production. You will work closely with Quality, Engineering, Planning, and Supply teams. We value clear communication, practical problem solving, and a focus on continuous improvement. This role offers growth, real impact on supply, and alignment with GSK’s mission of uniting science, technology and talent to get ahead of disease together.

Requirements

Bachelor’s Degree is required, preferably in the Sciences.
5 + years of experience working in a cGMP regulated manufacturing environment with 2 + years of supervisory experience.
Experienced in manufacturing, process development, and/or quality assurance in a biopharmaceutical environment.
Experience required in cGMP environment focused on design, qualification, and troubleshooting of processes and equipment with regulatory inspections.
Required experience working within a biological manufacturing facility with regulations governing the manufacturing and supply of pharmaceutical products.
Strong interpersonal, written and oral communication skills. Demonstrate ability to instill a proactive can-do attitude.
Exceptional organizational and leadership skills with the ability to lead a team and make critical decisions. Proven ability at working both as an individual and groups in a multi-tasking environment.
Experience in Quality Risk Management including root cause analysis with investigation and troubleshooting.
GPS, LEAN, OE, or similar continuous improvement methodologies.

Nice To Haves

Experience with continuous improvement methods such as Lean, Six Sigma, or GSK Production System tools.
Experience supporting regulatory inspections and preparing inspection-ready documentation.
Experience working with electronic batch records or manufacturing execution systems.
Demonstrated coaching and people development skills, including performance management and training.

Responsibilities

Ensure Process Safety, EHS and Regulatory Compliance. Be accountable for area EHS performance, promote a strong safety culture, and help sustain machinery safety management processes and procedures. Identify, report, and remove safety risks.
Ensure activities are executed in accordance with quality and regulatory standards. Promote a quality mindset and quality excellence in all activities. Implement and monitor quality systems to maintain inspection readiness, support effective risk management, participate in deviation investigations, and ensure compliance with applicable GSK Quality Management System policies, procedures, and Data Integrity ALCOA+ principles.
Assist with production planning to achieve departmental and site objectives. Deploy the performance management process within the area, using accurate and timely data to set, monitor, and achieve objectives, metrics, and targets. Work with other Supervisors to establish, monitor, and achieve annual manufacturing and delivery plans.
Ensure relevant production information and activities are tracked, captured, completed, and communicated to management as needed. This includes managing discretionary spend, coordinating with Technical Services to ensure preventive and predictive maintenance and calibrations are appropriate and completed on schedule, and supporting coordination between Manufacturing and QC for environmental monitoring and production processes.
Drive and embed the use of GSK Production System (GPS) tools and techniques to realize ever increasing levels of value from manufacturing operations. Must be an effective communicator, focus team by prioritizing what matters most and using data to drive decision making and develop self and team.
Support and develop team members through coaching and mentoring. Assign meaningful projects and challenging responsibilities to support development. Ensure compliance with relevant EHS, HR, Quality, and Finance policies.
Ensure all direct reports have clear written performance and development plans, receive regular performance feedback, and understand expectations to communicate effectively, focus on what matters most, use data to drive decisions, and develop themselves and their teams.
Act as a change agent by having personal responsibility for supporting the departmental and site level ways of working. Deal positively with change, demonstrating the ability to maintain high personal performance levels as the organization evolves. Positively influence others to adapt to change.
Hold employees accountable for supporting the Manufacturing department and site level ways of working. Guide staff through the change process and hold them accountable for moving through the process in a positive way. Support cross-functional communication. In addition, the Supervisor will instill pride and ownership within the organization.
Participate in the Validation Master Plan for production operations in partnership with the Validation team. Drive the PQ Master Plan and manage PQ activities for the area of responsibility, including development, writing, and execution of protocols and completion of final reports.
Participate in identifying and assessing risks and drive continuous improvement of business processes, production documentation and training material.
Lead safe and compliant DS production activities to meet quality and delivery targets. Supervise and develop production technicians and front-line leads to maintain capability and performance.
Manage daily production schedules, adjust priorities with Planning, and support supply continuity. Act as the operational point of contact for internal and external audits and inspections for your area.
Drive continuous improvement projects to reduce waste, improve yield, and increase operational stability. Oversee shift handovers, batch execution, documentation integrity, and timely closure of deviations.