Are you looking for an impactful role that leverages your technical expertise/ leadership and ability to build exceptional relationships with trusted global partners to develop an increased number of transformative medicines for our patients? If so, this Senior Director, Sterile DP Operations role in a rapidly growing, empowered, innovative and agile Strategic External Development (SED) organization developing transformative medicines could be an ideal opportunity to explore.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some/ all of the following:
- Lead an exceptional diverse team of 15-20+ SED experts (Manager - Director level) and 50-100+ people at global external partners
- Responsible for oversight of drug product development/CMC activities for 10-20+ late stage projects, including a variety of modalities, including mAbs, bispecifics, oligonucleotides, small molecules, etc.
- Ensure department talent strategy includes robust recruitment of top talent, development and cross-training plans that enables technical excellence, facilitates development of team members to their full potential and enables agility to support the future portfolio that could include a broad range of oral and sterile drug products, medical devices and combination products.
- Build an extensive network and strong relationships with key internal and external stakeholders including the broader Medicines Development and Supply organization, Global Supply Chain, alliance partners and CDMOs; effectively navigate a highly complex cross-functional internal and external CMC team environment.
- Participate in industry consortia, contribute to development of pharmaceutical industry best practices; leverage external insights in development of internal best practices.
- Engage with key external groups, including regulators in target markets to ensure that GSK's preferred approaches are discussed and, ultimately and ideally, accepted as the preferred path forward.
- Participate in internal Technical Advisory Panels, facilitate knowledge sharing and alignment with the broader GSK organization.
- Interface with SED leadership team, GSK governing committee(s); support CMC team in presenting programs/decisions to gain alignment and approval.
- Evolve agile ways of working and processes to enable accelerated drug product development and reduce time to patient.
- Support and execute strategic organizational decisions; lead or participate in strategic initiatives and cross-functional taskforces.
- Develop and implement external clinical drug product network strategy; conduct technical due diligence, selection and onboarding of CDMOs domestically and internationally. Oversee and facilitate implementation of new technologies and capabilities at external partner sites.
- Oversee externalized drug product development and clinical manufacturing efforts. Provide direction and oversight for process development/scale-up/transfer/process validation and investigation activities.
- 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 strategic input and technical review of CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses to regulatory questions.
We are looking for professionals with these required skills to achieve our goals:
- BS in Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline required and 15+ years of pharmaceutical industry experience in product development/CMC and manufacturing.
- Experience with sterile drug product development, manufacturing and commercialization of innovative and high quality products is required.
- People leadership and matrix leadership experience, including building and leading highly performing teams.
- Experience with phase-appropriate development strategies; IND/IMPD, NDA, and BLA submissions (or their regional equivalents) and responses to questions.
- Experience with CDMO selection, oversight and management of externalized development and manufacturing activities.
- Requires a flexible work schedule to accommodate program priorities and international activities. International travel will be required.
If you have the following characteristics, it would be a plus:
Why GSK?Uniting science, technology and talent to get ahead of disease together
- MS/PhD in Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline
- 15+ years of pharmaceutical industry experience and successful track record in sterile product development, manufacturing and commercialization, including mAbs, ADCs, small molecules, oligonucleotides, RNAs or vaccines.
- Experience working for a CDMO
- Experience with lyophilized products, prefilled syringes and/or combination products.
- Experience in drug product facility design, environmental controls and maintenance for the manufacture of sterile drug product.
- Understanding of the key risks and failure modes associated with the development process and clinical supply chain; QbD and product quality focus.
- Experience with oral solids, complex dosage forms is a plus.
- Excellent leadership skills; ability to identify, recruit, retain and develop top talent; lead large global matrix teams.
- Demonstrated capability to effectively manage multiple projects.
- Strategic, visionary thinker with strong critical thinking and decision-making skills, interpersonal and communication skills, ability to work within a complex network.
- Agility, courage to take smart risks and tough decisions, accountability.
- Ability to anticipate industry trends and emerging 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing.So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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