Medicine and Process Delivery Leader/ Sr. Director

Collegeville, Pennsylvania; Rockville, Maryland; Research Triangle Park, North Carolina
April 20 2021
Organization Type
Are you interested in a highly visible leadership opportunity that will allow you to develop and execute CMC project plans and accomplish strategic development objectives? The opportunity to enable timely introduction of business solutions and innovative technologies that have the potential to improve the patient experience, access to the product, the development/manufacture of the product or network efficiency? If so, this Biopharmaceutical Medicine & Process Delivery (MPD) Leader could be an ideal opportunity to explore.

The purpose of the Medicine and Process Delivery (MPD) Team is to be accountable for defining and successfully delivering the CMC and supply chain strategy and obtaining and managing associated resources. The MPD Leader is the single CMC accountable person for a project, across all indications and all therapeutic areas, and will ensure the integrated breadth and depth of CMC experience and expertise is brought to bear at the Medicines Development Team (MDT)/Project Team for the development lifetime of the medicine.

Job Purpose and Key Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

  • Leads as the appointed project (or projects) leader in the early to mid-phases of development and be the single point accountable person for all CMC and supply chain aspects during the development of a medicine
  • Leads teams from across R&D, manufacturing and corporate functions (and external partners) to develop the physical product and the manufacturing process, establish the supply chain and deliver the CMC regulatory files to enable clinical studies, a secure launch and ongoing commercial supply for one or more high complexity assets. Lead significant workstreams for a highly complex project and/or act as a delegate for the overall project.
  • Develops the integrated CMC/supply chain strategy and plan (technical, industrialization and lifecycle) and the CMC budget and is accountable for alignment of these with the Medicine Development Plan and for securing the necessary budget.
  • Provides the voice of CMC and supply chain to the medicine vision, the commercial product intent, the Medicine Development Team (MDT) and to key stakeholders.
  • Provides an input to the overall strategy and development of the product as a member of the MDT.
  • Assesses and integrates the cross-disciplinary (CMC, clinical and non-clinical) scientific knowledge for the project to ensure the physical product meets the needs of the patient.
  • Ensures the principles of quality by design (QbD) and quality risk management are applied in the development of a robust, fit for purpose, process.
  • Ensures compliance with GSK's policies and procedures on development and supply of the physical product and the new product supply/physical product development/CMC matrix processes, including the identification, assessment, escalation and management of technical, industrialization and lifecycle risks.
  • Leads timely review and governance at relevant internal CMC project review forums and the New Product Supply governance Board, specifically for milestone reviews and risk escalation.
  • Ensures the CMC R&D lines and the commercial manufacturing network are aware of the project's development and supply chain needs and plans and have the capacity and capability to enable excellent delivery in a timely and cost effective manner, always meeting the needs of the patient.
  • Develops a comprehensive lifecycle plan that covers the activities, timing, resources and capabilities required. Leads the effective transition of the supply chain to the commercial manufacturing organisation at an appropriate time post launch.
  • Evaluates and champions the timely introduction of business solutions and innovative technologies (in close collaboration with the technical lines and Advanced Manufacturing Technologies (AMT)) that have potential to improve the patient experience with the product, access to the product or the development/manufacture of the product.
  • May lead a project(s) on post launch assets to introduce innovative technology and/or improve product robustness.
  • Works with technical and legal experts to ensure timely review of intellectual
  • property opportunities, freedom to operate, licensing and trademarks for the product and the process.
  • Disseminates key learnings, good practices and knowledge across the CMC matrix and GSK as appropriate.
  • Selects, evaluates and supports the development of direct reports and core MPD team members (in conjunction with line leaders) to build future GSK talent and ensure successful delivery of the medicines.

Why you?

Basic Qualifications
  • Bachelor of Science with director level CMC experience in the development or manufacture of relevant pharmaceuticals
  • Excellent knowledge, through experience, of the relevant CMC and supply chain aspects of developing, manufacturing and industrializing biopharmaceuticals along with a thorough working knowledge of the pharmaceutical industry, relevant regulations and requirements.
  • Experience creating and defending CMC development strategy, plan and data package for an asset.
  • Project leadership experience, specifically leadership of multi-disciplinary teams and preferably in a relevant pharmaceutical product development environment with global teams.
  • Experience working at a senior level with both internal and external groups.

Preferred Qualifications
  • PhD/EngD with extensive CMC experience in the development or manufacture of relevant pharmaceuticals
  • Learning agility and desire to learn new things outside of one's comfort zone; willingness to take on diverse and agnostic assignments in product development.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk, managing ambiguity and paradox.
  • Managing individual performance.
  • Creating a performance culture and driving results, prioritisation, execution, delivering performance.
  • Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.

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