GlaxoSmithKline
Director, Parenteral Drug Delivery
GlaxoSmithKline, King of Prussia, Pennsylvania, United States,
Site Name:
UK - Hertfordshire - Ware, USA - Pennsylvania - King of PrussiaPosted Date:
Nov 1 2024Director, Parenteral Drug DeliveryThis role will preferably be based in GSK Ware, UK but can also be based in strategic East Coast, US locations.The Global Supply Chain Manufacturing Science and Technology (MSAT) organization is a network-focused function which provides strategic platform direction and technical and operational support to ensure that GSK Global Supply Chain network, site goals and objectives are achieved, with determined strategy executed.MSAT is the keeper of the body of manufacturing process knowledge, creates the instruction set and ensures manufacturing operations stay aligned with the registered process, with the primary objective being to ensure manufacturing processes are in control, compliant, performant & cost-efficient and remain state of the art.MSAT’s primary functions are to lead technology transfers, implement control strategies, provide technical process support across the product lifecycle, industrialising new products, platforms and new modalities into commercial manufacture and driving any product-related programs within the GSK Global Supply Chain.The Director, Parenteral Drug Delivery leads the diverse MSAT Global Device Engineering and Technology team focusing on delivering novel molecules in clinical and commercial biopharmaceutical products, deploying technical device applications and technologies as well as on delivering global technical device operations support and improvements to the existing supply chains.Director, Parenteral Drug Delivery oversees the technology transfer of drug delivery devices and combination product technologies from R&D, third party clients, and external Contract Manufacturing Organisations (CMOs) to and from GSK to other biopharmaceutical manufacturing sites. MSAT Device has responsibility for oversee and maintain combination product lifecycle management for all assets manufactured internally and externally, including technical, design control, verification and validation documentation, regulatory submission, inspection, and audit support. The Director of MSAT Device has direct responsibilities for continuously improved product quality among GSK assets containing drug delivery devices and combination products.The successful candidate will possess a high degree of emotional intelligence and be able to demonstrate their stakeholder influence and management skills.In this role you will:Lead and manage a high performing, engaged, and motivated MSAT Global Device organization capable of delivering the MSAT drug delivery devices and integral combination product strategic priorities.Be responsible for the technology transfer and introduction of new processes globally and has direct accountability for the global device assembly technology transfer and validation activities to deliver an asset that can achieve yields and product attributes necessary for meeting commercial supply demand.Be responsible for global device and combination product lifecycle management for all device products commercially managed at global sites including post-approval regulatory change management, continued process verification, and continued increase of production yields and decrease of COGs.Provide technical drug delivery device and combination product information to enable site selection and sourcing decisions on potential new products from GSK or contract partners to be made.Work cross-functionally to communicate technical global device challenges and successes and influence at all levels including the R&D and supply chain teams to ensure both technical and commercial success of drug delivery devices and integral combination products for GSK.CLOSING DATE for applications: 15th November 2024Please take a copy of the Job Description, as this will not be available post closure of the advert.When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.Basic Qualifications & Skills:BSc, MSc or PhD in a related scientific discipline such as chemical engineering, chemistry, pharmacy, or pharmaceutical engineering – preferably Chartered / Professional QualificationSignificant experience leading high performing teamsConsiderable experience in parenteral, device design, engineering, manufacturing and/or testing.Excellent project management, problem-solving, and decision-making skillsExcellent communication, interpersonal and influencing skills; ability to set ambitious goals and successfully drive results, define priorities, manage and influence matrix team performanceWorking knowledge of scale-up, technical transfer and process change management / improvement, with knowledge in current Good Manufacturing Practices and US/EU/ROW regulationsPreferred Qualifications & Skills:Ph.D. or MS degree with significant experience in parenteral, device design, engineering, manufacturing and/or testing.In depth knowledge of respiratory, parenteral and standalone devices, as well as primary containers, platforms and technology evolutions.In depth knowledge of medical device manufacturing processes (injection moulding, automated assembly etc).Thorough understanding of market and regulatory trendsAbility to work independently and follow through on assignments and delivery of the GSK GSC strategy without direction.Background and experience in leading platform / technology / matrix teams with specialist expertiseAbility to concisely communicate status, needs, forecasts, risks and timelines effectivelyAbility to display a clear willingness to listen to others and demonstrate good interpersonal skills and works collaboratively in an effective manner to achieve objectives.As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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 (US only).We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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UK - Hertfordshire - Ware, USA - Pennsylvania - King of PrussiaPosted Date:
Nov 1 2024Director, Parenteral Drug DeliveryThis role will preferably be based in GSK Ware, UK but can also be based in strategic East Coast, US locations.The Global Supply Chain Manufacturing Science and Technology (MSAT) organization is a network-focused function which provides strategic platform direction and technical and operational support to ensure that GSK Global Supply Chain network, site goals and objectives are achieved, with determined strategy executed.MSAT is the keeper of the body of manufacturing process knowledge, creates the instruction set and ensures manufacturing operations stay aligned with the registered process, with the primary objective being to ensure manufacturing processes are in control, compliant, performant & cost-efficient and remain state of the art.MSAT’s primary functions are to lead technology transfers, implement control strategies, provide technical process support across the product lifecycle, industrialising new products, platforms and new modalities into commercial manufacture and driving any product-related programs within the GSK Global Supply Chain.The Director, Parenteral Drug Delivery leads the diverse MSAT Global Device Engineering and Technology team focusing on delivering novel molecules in clinical and commercial biopharmaceutical products, deploying technical device applications and technologies as well as on delivering global technical device operations support and improvements to the existing supply chains.Director, Parenteral Drug Delivery oversees the technology transfer of drug delivery devices and combination product technologies from R&D, third party clients, and external Contract Manufacturing Organisations (CMOs) to and from GSK to other biopharmaceutical manufacturing sites. MSAT Device has responsibility for oversee and maintain combination product lifecycle management for all assets manufactured internally and externally, including technical, design control, verification and validation documentation, regulatory submission, inspection, and audit support. The Director of MSAT Device has direct responsibilities for continuously improved product quality among GSK assets containing drug delivery devices and combination products.The successful candidate will possess a high degree of emotional intelligence and be able to demonstrate their stakeholder influence and management skills.In this role you will:Lead and manage a high performing, engaged, and motivated MSAT Global Device organization capable of delivering the MSAT drug delivery devices and integral combination product strategic priorities.Be responsible for the technology transfer and introduction of new processes globally and has direct accountability for the global device assembly technology transfer and validation activities to deliver an asset that can achieve yields and product attributes necessary for meeting commercial supply demand.Be responsible for global device and combination product lifecycle management for all device products commercially managed at global sites including post-approval regulatory change management, continued process verification, and continued increase of production yields and decrease of COGs.Provide technical drug delivery device and combination product information to enable site selection and sourcing decisions on potential new products from GSK or contract partners to be made.Work cross-functionally to communicate technical global device challenges and successes and influence at all levels including the R&D and supply chain teams to ensure both technical and commercial success of drug delivery devices and integral combination products for GSK.CLOSING DATE for applications: 15th November 2024Please take a copy of the Job Description, as this will not be available post closure of the advert.When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.Basic Qualifications & Skills:BSc, MSc or PhD in a related scientific discipline such as chemical engineering, chemistry, pharmacy, or pharmaceutical engineering – preferably Chartered / Professional QualificationSignificant experience leading high performing teamsConsiderable experience in parenteral, device design, engineering, manufacturing and/or testing.Excellent project management, problem-solving, and decision-making skillsExcellent communication, interpersonal and influencing skills; ability to set ambitious goals and successfully drive results, define priorities, manage and influence matrix team performanceWorking knowledge of scale-up, technical transfer and process change management / improvement, with knowledge in current Good Manufacturing Practices and US/EU/ROW regulationsPreferred Qualifications & Skills:Ph.D. or MS degree with significant experience in parenteral, device design, engineering, manufacturing and/or testing.In depth knowledge of respiratory, parenteral and standalone devices, as well as primary containers, platforms and technology evolutions.In depth knowledge of medical device manufacturing processes (injection moulding, automated assembly etc).Thorough understanding of market and regulatory trendsAbility to work independently and follow through on assignments and delivery of the GSK GSC strategy without direction.Background and experience in leading platform / technology / matrix teams with specialist expertiseAbility to concisely communicate status, needs, forecasts, risks and timelines effectivelyAbility to display a clear willingness to listen to others and demonstrate good interpersonal skills and works collaboratively in an effective manner to achieve objectives.As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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 (US only).We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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