Manager/ Scientific leader - External development
We are building a state-of-the-art end to end Biopharm capability which delivers efficient discovery of antibody molecules that are selected and engineered for rapid development so that, together with our therapy area partners, we discover, develop and manufacture novel portfolio of exciting medicines to benefit patients around the world. If you aim to be part of a global cutting edge drug development and discovery organization and are motivated to contribute towards bringing lifesaving drugs to patients, join us! Click to know more about GSK Biopharm. #GSKBiopharm_Development GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Biopharm Process Development is a highly experienced Chemistry, Manufacturing and Controls (CMC) organization accountable for delivering robust, cost effective and competitive products and manufacturing processes spanning the full life cycle of asset development from Discovery through commercialization. These activities are delivered through state-of-the-art internal facilities as well as strategic external partners. Collectively, the team is accountable for CMC activities encompassing cell line development, cell culture/ microbial fermentation, purification development, and drug product/ device development. We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience. The successful candidate will join a Product Development Team within the Biopharmaceutical Product Sciences and Device Engineering (BPS) department of the Biopharm Product Development & Supply organization within GSK R&D, and will focus on the externalization of projects or specific work packages to key partners of the BPS-DE organization in both the US and the UK. In addition, the candidate will support the development of the early phase portfolio including developing drug product formulation, manufacturing process, and biophysical analysis of protein & peptide-based therapeutics. When/where possible, some travel may be necessary to support the outsourcing elements. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Operating as the primary interface between selected external partners and internal development teams; management of an on-site analytical team to provide flexible capacity modulated by portfolio demand; management of strategic partnerships established with key vendors through relationship building; establishing robust externalization ways of working for the BPS-DE organization within the GSK third party resourcing framework; providing guidance to technical development teams that would benefit from externalization; building partnerships/ relationships within the GSK externalization community to deliver on the departmental book of work; be accountable for the oversight of externalized activities; authoring technical elements of Statements of Work (SoW) to enable protocol driven studies required to support drug product development; Collating metrics around cost/resource/duration of externally executed work packages for the BPS department; actively seeking new strategic external partners and capabilities that would benefit the organization; working closely with internal & external discovery and development support partners, as needed Supporting the progression of the early phase portfolio including managing assets from candidate selection through to phase 2a, included servings as the drug product lead within matrix teams, shelf life assignment, drug product manufacturing process development and support, supporting clinical in-use assessments and administration, and authoring regulatory submissions. The laboratory experimentation and bioanalytical testing of formulations & drug product manufacturing and administration/delivery approaches for early phase protein therapeutic assets, which includes contributing to the conception & evaluation of conventional & novel product matrices and administration modalities; physicochemical and bioanalytical characterization of native and modified biopharm compounds; crafting & execution of non-GMP stability protocols to test quality & stability of product formulations; maintaining accurate, complete laboratory records/ reports with a high level of data integrity following ALCOA+ principles; embody the GSK values and expectations; facile use of electronic data & information gathering, capture, archiving and communications techniques; and, assisting in preparation and review of SOPs, and regulatory documentation, as appropriate. Supporting the progression of the early phase portfolio including managing assets from candidate selection through to phase 2a, included servings as the drug product lead within matrix teams, shelf life assignment, drug product manufacturing process development and support, supporting clinical in-use assessments and administration, and authoring regulatory submissions. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: The ideal candidate will have a PhD degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline with 7+ years of protein formulation and drug product development experience; or, MS degree with 10+ years of similar experience; or, BS degree with 15+ or more years of similar experience Experience working directly with external contract research organizations/partners including the outsourcing of work packages, contract review, and generating statements of work Ability to lead collaborative external testing, data, and experimental plan reviews, as well as the use of external data to support critical internal decisions and regulatory submission Experience in biopharmaceutical product development including formulation, stability, processing, delivery Experience with bioanalytical and biophysical testing, data analysis, method troubleshooting Demonstration of data integrity principles including ALCOA Preferred Qualifications: If you have the following characteristics, it would be a plus: The candidate must be a creative and motivated self-starter, with excellent verbal and written communication skills Ability to work independently and across organizational and geographic boundaries as well as work effectively in team and matrix environments. Ability to demonstrate the ability for sound and timely decision-making and problem-solving skills in high impact situations. Experience in facile use of electronic data & information gathering, capture, archiving and communications techniques. 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. *LI-GSK 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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