GlaxoSmithKline
Director, Drug Product Strategic Alliance
GlaxoSmithKline, Rockville, Maryland, us, 20849
Site Name:
Home Worker - USA, USA - Maryland - Rockville, USA - Massachusetts - Boston, USA - Pennsylvania - PhiladelphiaPosted Date:
Aug 22 2024At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.Drug Product (DP) is one of the core functions of GSK Technical R&D, accountable for vaccine product and process development from the early onset of discovery projects and platforms to late-stage development, transfer and launch of new vaccines.The Director, Drug Product Strategic Alliance defines, leads, and transversally coordinates external strategic partnership for DP CMC development, ideally matching with the clinical material manufacturing footprint, and creating a network of trusted partners to execute delivery of robust, fit for purpose product and process development.Key Responsibilities:
Manage multiple drug product external development efforts for vaccine drug product programs within GSK's development portfolio.Build strong internal and external relationships with key stakeholders to help facilitate the delivery of DP objectives.Provide direction and oversight for process development/scale-up/transfer activities at external development sites.Provide leadership to ensure scientific excellence in study design, data collection and interpretation, and management within scope to prospectively agreed objectives, budget and timelines.Provide critical analysis of program challenges and opportunities and recommend mitigation plans where necessary.Support/lead and/or coordinate joint technical investigations connecting partners to internal experts to secure a path forward for programs.Assist project management to proactively build detailed CMC timelines with clarity on assumptions, risks and decision points.Prepare and keep current written CMC development strategies in alignment with overall program objectives.Coordinate the evaluation of external and internal technologies, encompassing formulation, delivery systems, manufacturing platforms, to ensure strong decision-making on externalization.Lead the strategic alliance in collaboration with R&D functions, Legal, IP and BD departments, with relevant stakeholders/customer functions.Serve as a member of the global Drug Product leadership team, contributing to the strategic vision and collaborating across the TRD global network.Collaborate effectively with the internal DP Development units to build an externalization framework where DP project leads from the development units can operate and secure the project deliverables.Apply Quality by Design (QbD) and Design of Experiment (DoE) studies to assess robustness and optimization of attributes of drug product formulation and manufacturing process with the external partner.Secure investment to progress through creation of business cases.Basic Qualifications:
MS degree in chemistry, biology, bioengineering or pharmacy5+ years of experience in the Drug Product technical development areaExperience in delivery systems, product pre-formulation and formulationExperience in Late and/or Early process developmentPreferred Qualifications:
Demonstrated ability to design, manage and deliver on complex projects in the field of science and technologyExperience leading a team of scientific experts across multiple sitesKnowledge of Vaccine manufacturing environmentUnderstanding of external key players in the fieldExperience leading a matrix teamLearning agility, high level of autonomy and desire to learn new things outside of one's comfort zoneExperience in transversal function or team managementStrong leadership and communication skillsThe annual base salary for new hires in this position ranges from $172,550 to $233,450, taking into account a number of factors including work location, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share-based long-term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.Why GSK?Uniting science, technology and talent to get ahead of disease together.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 organization where people can thrive.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles.
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Home Worker - USA, USA - Maryland - Rockville, USA - Massachusetts - Boston, USA - Pennsylvania - PhiladelphiaPosted Date:
Aug 22 2024At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.Drug Product (DP) is one of the core functions of GSK Technical R&D, accountable for vaccine product and process development from the early onset of discovery projects and platforms to late-stage development, transfer and launch of new vaccines.The Director, Drug Product Strategic Alliance defines, leads, and transversally coordinates external strategic partnership for DP CMC development, ideally matching with the clinical material manufacturing footprint, and creating a network of trusted partners to execute delivery of robust, fit for purpose product and process development.Key Responsibilities:
Manage multiple drug product external development efforts for vaccine drug product programs within GSK's development portfolio.Build strong internal and external relationships with key stakeholders to help facilitate the delivery of DP objectives.Provide direction and oversight for process development/scale-up/transfer activities at external development sites.Provide leadership to ensure scientific excellence in study design, data collection and interpretation, and management within scope to prospectively agreed objectives, budget and timelines.Provide critical analysis of program challenges and opportunities and recommend mitigation plans where necessary.Support/lead and/or coordinate joint technical investigations connecting partners to internal experts to secure a path forward for programs.Assist project management to proactively build detailed CMC timelines with clarity on assumptions, risks and decision points.Prepare and keep current written CMC development strategies in alignment with overall program objectives.Coordinate the evaluation of external and internal technologies, encompassing formulation, delivery systems, manufacturing platforms, to ensure strong decision-making on externalization.Lead the strategic alliance in collaboration with R&D functions, Legal, IP and BD departments, with relevant stakeholders/customer functions.Serve as a member of the global Drug Product leadership team, contributing to the strategic vision and collaborating across the TRD global network.Collaborate effectively with the internal DP Development units to build an externalization framework where DP project leads from the development units can operate and secure the project deliverables.Apply Quality by Design (QbD) and Design of Experiment (DoE) studies to assess robustness and optimization of attributes of drug product formulation and manufacturing process with the external partner.Secure investment to progress through creation of business cases.Basic Qualifications:
MS degree in chemistry, biology, bioengineering or pharmacy5+ years of experience in the Drug Product technical development areaExperience in delivery systems, product pre-formulation and formulationExperience in Late and/or Early process developmentPreferred Qualifications:
Demonstrated ability to design, manage and deliver on complex projects in the field of science and technologyExperience leading a team of scientific experts across multiple sitesKnowledge of Vaccine manufacturing environmentUnderstanding of external key players in the fieldExperience leading a matrix teamLearning agility, high level of autonomy and desire to learn new things outside of one's comfort zoneExperience in transversal function or team managementStrong leadership and communication skillsThe annual base salary for new hires in this position ranges from $172,550 to $233,450, taking into account a number of factors including work location, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share-based long-term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.Why GSK?Uniting science, technology and talent to get ahead of disease together.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 organization where people can thrive.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles.
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