GSK - Marietta, PA

posted 16 days ago

- Senior
Marietta, PA
Chemical Manufacturing

About the position

Are looking for a process and validation leadership role that allows you to leverage your technical expertise to drive quality assurance and compliance in a highly technical manufacturing environment? If so, this MSAT Team Lead role could be an exciting opportunity to explore. As an MSAT Team Lead, you will be responsible for leading a team of Process and Validation Specialists/SME's to manage and deliver the product and project portfolio, including new product introduction and complex changes to existing products, processes and equipment technologies, to meet business demands.

Responsibilities

  • Develop, motivate, focus, care and lead a highly competent team of Process and Validation Specialists/SME's to deliver projects, discharge risks, implement complex changes and to maintain standards and knowledge management systems for the site.
  • Feeding into the sites Strategic Workforce Planning, through strong succession planning & performance management.
  • Operate in line with GSKs leadership expectations & promote correct behaviors & ways of working to their team & other employees.
  • Use Workday and the supporting 70:20:10 framework to agree development plans for team members.
  • Partner with team members to support development plans to increase and sustain capability within the MSAT team.
  • Recruit staff as required in order to deliver projects per timelines.
  • Adhere to the performance management system, holding regular structured performance meetings with all employees in their reporting line.
  • Align themselves & their teams to site priorities, business objectives through effective team leadership & stakeholder management.
  • Maintain individual and staff compliance with all related policies and procedures (including GMP; Environmental, Health & Safety; and QMS).
  • Industrialize technical transfer of commercial products within Global Supply Chain and other third-party sites as applicable.
  • Acquire, maintain and manage product and process knowledge throughout the product lifecycle.
  • Ensure appropriate systems to track, trend and analyze product and process data are in place in use and applied to monitor product/process performance and drive improvement.
  • Approve and resource MSAT aspects of planned changes for new and commercial products through effective risk management processes.
  • Provide technical leadership into complex product performance investigations & lead the introduction of highly capable new process technologies.
  • Ensure day to day technical issues are resolved urgently to minimize impact on project(s)/product performance or reject/waste levels.
  • Actively facilitate the improvement of product and process capability across the supply chain.

Requirements

  • Minimum 10 years' experience with BS in vaccine pharmaceutical process experience, preferably a multinational one.
  • Minimum 5 years' experience with PhD in vaccine pharmaceutical process experience, preferably a multinational one.
  • Minimum 5 years' demonstrated experience in the Vaccine Pharmaceutical industry in leading the technical aspects of the Product Lifecycle.

Nice-to-haves

  • In-depth knowledge and understanding of vaccine's raw materials, single use system, filtration, homogeneity, complexation, buffer preparation, formulation, aseptic filling, automated visual inspection and testing.
  • Experience with investigational techniques, tools for process investigations and trouble shootings.
  • Ability to lead, motivate, focus, care and develop others.
  • Ability to translate site strategy into team goals and objectives, plan and allocate resources, negotiate support and manage conflicting priorities.
  • Track record of improving products, processes and troubleshooting with data and results driven mindset.
  • Working knowledge of vaccine manufacturing and the associated materials, components, unit operations, critical parameters and controls.
  • Strong analytical and problem-solving skills and ability to generate, use and interpret data to drive decision-making at both tactical and strategic level.
  • Excellent verbal and written communication skills, including the ability to author technical reports and review and approve reports written by others.
  • Must be flexible, adaptable, and a strong team player.
  • Strong negotiating and influencing skills and ability to resolve conflict.
  • Understanding of manufacturing operations and ways of working.
  • Working knowledge of operational excellence methods and tools (e.g. FMEA, Root Cause Analysis, GPS).
  • Good knowledge of internal and external EHS, Quality, Regulatory and GMP requirements.
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