Head of CMC and Non-clinical Project Management
1 month ago
We are seeking a highly experienced and skilled Head, CMC & Non-clinical Project Management to lead our project management function in Medicine, Development & Supply. As a key member of our R&D team, you will be responsible for setting the standard of excellence for professional project management of complex technical projects.
Key Responsibilities:- Lead the CMC & NC PM, MDS project management function supporting the whole R&D portfolio from peri-CS through to post-launch.
- Develop, implement and maintain a project planning and management capability to enable and deliver the technical and supply aspects of all GSK's Pharma R&D pipeline medicines effectively and productively.
- Maintain awareness of internal and external project management practice to ensure currency of MDS's approach and work to continuously improve the competency level of project management across CMC & NC PM, MDS.
- Maintain awareness of platform technology, CMC, supply chain, non-clinical safety and DMPK trends to ensure work package libraries and project plans are fit for purpose.
- Provide operational input and review to ensure PM resource allocation is in alignment with project and portfolio workload forecasts and priorities across the R&D portfolio.
- Be the point of contact for all partners and stakeholders to drive consistent, integrated, strategic project and resource management across CMC & NC PM, MDS.
- Bachelor's degree in a life sciences or business discipline.
- 10+ years experience in pharmaceutical R&D or pharmaceutical manufacturing, with 5+ years experience in project management.
- Experience leading a global function consisting of 25+ team members.
- MSc or PhD degree in scientific or engineering discipline together with substantial industry experience, preferably with CMC or other Pharma platform technology experience.
- In depth understanding of drug development processes, regulations, and requirements with a good awareness of medicine commercialization.
- Ability to build credibility quickly across a diverse range of teams, seniority, and geography with high level of personal integrity plus ability to handle highly confidential information appropriately.
- Ability to employ highly effective decision-making strategies with sound technical and business judgement to resolve issues and conflicting options with high risk / impact to the organization.
- Highly effective influencing and negotiations skills in challenging, ambiguous and/or changing environments, with or without formal authority and across all levels of an organization.
- Ability to work with project teams and senior leadership teams to identify novel solutions to both project-specific and portfolio wide issues.
GSK is 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.
We are an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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Head of CMC and Non-clinical Project Management
1 month ago
Ware, Hertfordshire, United Kingdom 1925 GlaxoSmithKline LLC Full timeJob SummaryWe are seeking a highly experienced and skilled Head, CMC & Non-clinical Project Management to lead our project management function in the Medicine, Development & Supply (MDS) organization. This role will be responsible for setting the standard of excellence for professional project management of complex technical projects, ensuring plans and...
-
Head of CMC and Non-clinical Project Management
1 month ago
Ware, Hertfordshire, United Kingdom 1925 GlaxoSmithKline LLC Full timeJob SummaryWe are seeking a highly experienced and skilled Head, CMC & Non-clinical Project Management to lead our project management function in the Medicine, Development & Supply (MDS) organization. This role will be responsible for setting the standard of excellence for professional project management of complex technical projects, ensuring plans and...
-
Head of CMC and Non-clinical Project Management
1 month ago
Ware, Hertfordshire, United Kingdom 1925 GlaxoSmithKline LLC Full timeJob SummaryWe are seeking a highly experienced and skilled Head, CMC & Non-clinical Project Management to lead our project management function in Medicine, Development & Supply. As a key member of our R&D team, you will be responsible for setting the standard of excellence for professional project management of complex technical projects.Key...
-
Head of CMC and Non-clinical Project Management
1 month ago
Ware, Hertfordshire, United Kingdom 1925 GlaxoSmithKline LLC Full timeJob SummaryWe are seeking a highly experienced and skilled Head, CMC & Non-clinical Project Management to lead our project management function in Medicine, Development & Supply. As a key member of our R&D team, you will be responsible for setting the standard of excellence for professional project management of complex technical projects.Key...
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Ware, Hertfordshire, United Kingdom 1925 GlaxoSmithKline LLC Full timeJob Purpose:As a key member of our team, you will lead CMC regulatory activities in the global lifecycle management of biopharmaceutical products. You will oversee a team ensuring compliance with company policies and procedures, staff development, and training to deliver roles.Key Responsibilities:Represent Global CMC Regulatory on Regulatory Networks and...
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Ware, Hertfordshire, United Kingdom 1925 GlaxoSmithKline LLC Full timeAbout the Role:We are seeking a highly skilled Regulatory Affairs Manager to join our team at 1925 GlaxoSmithKline LLC. As a key member of our CMC Regulatory Affairs team, you will be responsible for ensuring the global regulatory compliance of our products throughout the investigational, late phase development, and early commercial lifecycle management.Key...
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