Role Summary
Director of Large Scale Manufacturing at Rockville, MD. Lead operational excellence, safety and quality for production in a designated Value Stream, driving site strategy and ensuring delivery of business targets in a large-scale manufacturing environment.
Responsibilities
- Accountable for product quality, employee safety, cGMP compliance, OSHA compliance and consistently achieving performance goals to meet current and future market demand.
- Develop a diverse and inclusive culture that improves safety and quality while delivering service and cost improvements.
- Collaborate with the Site Leadership Team to align resources and set priorities to deliver a balanced scorecard.
- Set goals to achieve top quartile performance in pharmaceutical manufacturing.
- Align business objectives with GSK central functions to support strategic priorities and ensure team success.
- Develop GPS capability within the Value Stream to accelerate performance delivery.
- Work with GSC strategy and GSK partners to develop targeted product cost of goods to meet COGs targets.
- Develop and implement a robust succession pipeline for the Value Stream, Site and GSK.
- Standardize ways of working across systems, processes and equipment to maximize performance and compliance.
- Accountable for the P&L of the Value Stream, shortβΓΓ¬ to mid-term budget delivery, and improving flow to maximize efficiency and minimize working capital.
Qualifications
- Required: Bachelor of Science βΓΓ¬ biological/chemical science or any discipline of engineering
- Required: 10+ years of experience in biopharma/pharmaceutical clinical and/or commercial manufacturing
- Required: Experience leading others at a GMP drug substance biopharma site (fermentation/cell culture, purification, buffer/media prep, supply chain, manufacturing strategy, equipment commissioning/validation, change management, process validation, product registration, and/or product lifecycle management)
Preferred Qualifications
- MasterβΓΓ΄s degree in engineering, science, or business administration
- Experience in large-scale manufacturing environments
- Strong quality, compliance, and safety orientation with regulatory agency interfacing experience
- Excellent leadership, cross-functional collaboration, and influencing skills; strong focus on teamwork and business results
- Problem-solving mindset and relentless continuous improvement
- Strategic agility, organizational savvy, and business acumen to deliver near-term and long-term goals