Director, CMC Externalization and Partner Governance
Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence, USA - Pennsylvania - King of Prussia Posted Date: Mar 29 2021 In the coming years, the modality of molecules in GSKs pipeline combined with the likely accelerated nature of the approval pathways is potentiating a significant growth mode in the need for flexible resources, new technologies, varied capabilities and increased capacities that are not currently available within GSK's current internal infrastructure. This growth mode is bifunctional in nature spanning both small and large molecules as well as development and commercial operations. To that end, GSK has established the Strategic External Development (SED) and Specialty External Manufacturing (SEM) organizations to harness the ambition. The intent of these organizations is to build and expand a platform of strategic external partnerships that provide the necessary growth flexibility required to deliver GSK's building portfolio of products including Oncology, Immuno-inflammation, HBV and HIV. The Strategic External Development (SED) team is an empowered, innovative and agile CMC development organization that will unlock the potential to rapidly deliver an increased number of transformative medicines to patients through exceptional relationships with trusted global partners. The role is crucial to build relationships that ensure continuous improvement of how GSK and our partners work together. This role is essential for ensuring that the relationships are managed, and issues are appropriately escalated, across the governance framework including interactions with the senior leaders of the suppliers to ensure the relationships deliver value to GSK long-term. The purpose of this job is to provide effective management of strategic suppliers which requires a great level of technical knowledge and experience of pharmaceutical development and commercial supply along with a strong business and organizational understanding of contracting and legal aspects. This is a critical role that is essential for ensuring progression of activities executed by our strategic suppliers which are pivotal to the delivery of the R&D pipeline. The successful candidate will ensure that the relationships are managed, and issues are appropriately escalated, across the governance framework including interactions with the senior leaders of the suppliers to ensure the relationships deliver value to GSK long-term. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Direct and manage SED's externalization partnership vision to drive an ‘external intent' philosophy by executing a strategy to build a trusted infrastructure of strategic partners capable of delivering GSK's portfolio of externalized products. Direct, manage and influence a multifaceted team to develop external intent practices, build a strategic capacity/capability picture with respect to leveraging external development and manufacturing partnerships. Direct and manage GSK's interactions with selected strategic partners across CDMOs, governmental agencies and other relevant externalization areas to deliver the E2E SED plan. ensure delivery to defined goals (e.g. master services agreement, scopes-of-work etc.). share learnings and best practice from partners back to GSK and vice versa build the business relationship to engender mutual trust and provide timely feedback Direct and manage the identification of need for revised technical deal terms, oversight, and relationship management as the alliance progresses and negotiating these with the partner company. Ensure contractual aspects meet the needs of SED and their products and ensure the right technical and service terms are incorporated. Ensure risks are identified and escalated to GSK senior management (i.e. SED-LT, BPDS-LS, PDS-LT and Pharma Supply Chain teams), and that these risks are effectively mitigated through appropriate corrective action. Apply pharmaceutical drug development knowledge to drive performance and delivery through external supply partnerships. Coordinate activities in a matrix environment to ensure products manufactured are right first time, meet GSK standards, are delivered to patients on time Responsible for engendering trust, oversight, escalation and prioritization of appropriate activities as part of the Governance Framework with partners through Joint Steering and Joint Operating Committees Ensure a good understanding of CMC-related aspects of products in scope of partnerships via effective partnerships with internal stakeholders in the areas of Biologics Operations, Analytical Development, Biologics Drug Product Development, CMC Project Management, Quality Assurance and Quality Control, Regulatory Affairs, and Commercial Manufacturing and external CDMO business partners Responsible for assembling and maintaining the evolving capabilities of our partners including process development, testing and manufacturing related aspects. Responsible for contribution to category refresh and dose form review activities in partnership with the Pharma Supply Chain and Procurement. May perform due diligence activities and provide oversight to external manufacturing. Some domestic and international travel required. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS Degree (or international equivalent) in chemical/biochemical engineering, chemistry, biology, biochemistry, or related technical discipline. 10+ years of experience in pre-clinical drug development or biopharmaceutical manufacturing in a technical role 3+ years experience working with external CDMO partners in the CMC space. Experience in product development. Experience with technology transfers to internal or external site. Experience with product registration related activities (including but not limited to pivotal batch and validation campaigns). Experience in CMO relationship and performance management within the pharmaceutical sector. GMP Experience. Must have fluent English written and verbal communication skills. Preferred Qualifications: If you have the following characteristics, it would be a plus: PhD degree in chemical/biochemical engineering, chemistry, biology, biochemistry, or related technical discipline strongly preferred Business experience (either through MBA or equivalent) in addition to post graduate scientific training strongly preferred Experience with small and large molecule CMC development is strongly preferred Working knowledge of late stage development activities associated with regulatory submissions (NDA/BLA/MAA) Experience and appreciation of partnering with CDMOs during development through commercialization Ability to work in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities. Strong communication skills: ability to communicate (verbally and in writing) technical and non-technical information clearly to a diverse audience. Self-motivated, with the ability to act with urgency and passion. Proven ability to work with at a high level of integrity, accuracy, and attention to detail. Ability to advocate and influence at senior levels. Ability to make thoughtful, integrated, timely and meaningful recommendations and/or decisions and take corresponding actions. Resourceful, enthusiastic, innovative and results-oriented. Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of confidentiality. Highly developed problem solving and risk management skills. Ability to effectively communicate and understand international business relationships. Ability to lead cross functional teams to an aligned strategy. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk. Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *This is a job description to aide in the job posting, but does not include all job evaluation details. 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. 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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