Drug Substance Production Supervisor

GlaxoSmithKline; Marietta (PA); On-site; USD 120,000 - 180,000; Full time

Job summary

GlaxoSmithKline in Marietta, PA, seeks a senior supervisor to lead day-to-day Drug Substance (DS) manufacturing operations, ensuring safe, compliant and timely delivery of products. You will supervise a multidisciplinary team, drive quality, and partner with Quality, Engineering, Planning and Supply teams to meet site objectives.

You will lead staff training, use GPS and Lean methods, support audits, and foster a culture of continuous improvement, safety, and performance in a cGMP environment.

Qualifications

• Bachelor’s Degree in the sciences is required.
• 5+ years of experience in a cGMP manufacturing environment with 2+ years of supervisory experience.
• Experience in biopharmaceutical manufacturing and regulatory inspections.
• Strong interpersonal and communication skills.
• Ability to lead teams and make critical decisions.
• Experience with Quality Risk Management and root-cause analysis.
• Experience with GPS, LEAN, OE, or similar continuous improvement methods.

Responsibilities

• Ensure Process Safety, EHS and Regulatory Compliance.
• Lead a multi-disciplinary team to meet safety, quality, and delivery targets.
• Manage production plans and scheduling with Planning.
• Coordinate with Quality, Engineering, Planning, and Supply teams.
• Drive GPS tools and continuous improvement initiatives.
• Prepare for audits and inspections and maintain documentation.

Skills

Leadership

Communication

Problem solving

Team management

Decision making

Education

Bachelor’s degree in sciences

Tools

GPS tools

Quality systems

Job description

Business Introduction

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary

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.

Key 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.

Basic Qualifications

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.

Preferred Qualifications

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.

Work arrangement

This role is on-site and in a controlled manufacturing environment. You may be required to work rotating shifts, weekends, or holiday coverage based on site needs. You must be able to perform work duties safely and in close proximity to magnetic equipment.

Skills

• Data Integrity
• Detail-Oriented
• Digital Fluency
• Emergency Response
• Financial Acumen
• GxP Regulations
• Lean Management
• Manufacturing Processes
• Problem Solving
• Production Management
• Project Coordination
• Quality Compliance
• Regulatory Compliance
• Risk Awareness
• Site Operations

Equal Opportunity Statement

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Referral Policy

Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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Company Culture

We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.