Biopharmaceutical Cmc Leader - Stevenage, United Kingdom - GSK

GSK
GSK
Verified Company
Stevenage, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

Site Name:
USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage


Posted Date:
Jan

  • Are you energized by a highly visible leadership role that allows you to deliver our innovative portfolio of biopharmaceutical assets? If so, this CMC Development and Industrialization Leader role is an exciting move to explore_
  • As a Biopharmaceutical CMC Leader, you will lead delivery of the CMC development, supply, and regulatory plans with a high performing matrix team to deliver innovative medicines to patients._
  • This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following _

Lead CMC development and industrialization of a medicine:

  • Lead the definition and delivery of global CMC strategy and plan for a key medicine, aligning with global medicine strategy, patient needs, commercial intent, overall business context and regulatory, compliance and manufacturing network requirements.
  • Provide options for CMC delivery to align with the project objectives, with recommendations on implications (risks, costs, resources and time) for the global lifecycle of the medicine.

Leads the CMC matrix team:


  • Lead crossfunctional multidisciplinary CMC matrix team (~10 core and ~50 extended members) to develop and deliver CMC project plans to time, budget and resource forecasts.
  • Own the performance of the CMC matrix team: partner with line managers to appropriately resource the project with the right expertise, and to develop and support the core and extended team members to drive performance and deliver the project.

Be the Voice of CMC for the project:

  • Influence medicine development and commercialization plans and appropriate investment in CMC activities, and to the functional lines to ensure capability and capacity to deliver.
  • Provide CMC input to due diligence reviews of business development proposals, including opportunities and risks in the context of the proposed medicine and business strategy.

Provide Enterprise leadership of product portfolio and CMC Operating Model:

  • Understand cross-portfolio CMC performance, identify and drive strategic improvements.
  • Align senior leaders across R&D and GSC on strategic CMC plans and risk mitigation activities and the investments and resources required to deliver.

Skills and competencies


This role requires the knowledge, courage and credibility to lead a high performing multi-disciplinary matrix team of CMC and supply chain experts to develop and deliver the manufacturing process, supply chain, physical medicinal product and regulatory submissions to enable clinical trials, regulatory approval and a secure commercial supply of a medicine.


An exceptional matrix leader:


  • Sets direction, empowers others, monitors progress, knows when and how to intervene to avoid or manage risks and issues, helps remove barriers, holds team members accountable
  • Strong communicator, decision maker, agile learner, masterful manager of conflict
  • Able to analyze complex situations to provide innovative solutions and clear direction
  • Able to influence at very senior levels in the business and across multiple disciplines
  • Collaborative, inclusive and transparent, builds and cultivates high performing partnerships

A highly credible CMC or supply chain expert:

  • Strong knowledge of Biopharm development, manufacturing, supply chain, and quality
  • Knowledge of E2E nonclinical, clinical, regulatory and commercial aspects of development

Business savvy:


  • Connected to the broader business with a wide internal and external network.
  • Balances scientific, technical and manufacturing risks against the overall business impact.
  • Understands the business financial context within which decisions are made.

Experience

  • Experience in CMC Biopharm development including late stage through approval/launch
  • Successful developer of people as a mentor, coach, matrix or line leader
  • Leader of global crossfunctional teams, including external partners, with high accountability

_ Why you?_:


Basic Qualifications:


  • We are looking for professionals with these required skills to achieve our goals:_
  • Bachelor of Science in a relevant science or engineering discipline
  • 10+ years' experience in Biopharm CMC development, manufacture, or supply, plus relevant regulations
  • Line or matrix leadership experience of large multidisciplinary global teams
  • Director level experience working with both internal and external partners and senior leaders

Preferred Qualifications:


  • If you have the following characteristics, it would be a plus:_
  • 15 Years experience a plus
  • MS/MBA or PhD/EngD with senior director level leadership experience in the development or manufacture of biopharmaceuticals.
LI-GSK
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_This is a job description to aide in the job posting, but does not include all job evaluation details._
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