Scientific Leader, Biologics Drug Product Development
Site Name: USA - Pennsylvania - Upper Providence Posted Date: Jun 2 2021 GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to support our mission to improve the quality of human life by enabling people to do more, feel better and live longer. Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. The Scientific Leader, Biologics Drug Product (DP) Development and Submissions will bring expertise in biologic product or drug-device combination product development to facilitate functional preparation of product-related submissions and template development. The Scientific Leader will serve as a drug product and device dossier-facing subject matter expect who works across BioPharm Product Sciences and Device Engineering to coach authors to ensure appropriateness and consistency of content of the DP sections. The Scientific Leader will support DP portions of submissions during preparation, review and response to health authority questions. The Scientific Leader will monitor regulatory feedback across product submissions and broader trends in the drug product and device regulatory landscape to facilitate integration of lessons learned and regulatory trends into biologics product and modality-agonist device development plans across the GSK portfolio. The Scientific Leader will work closely with the submission working groups, BPSDE management, project teams and broader staff. The Scientific Leader will maintain awareness of key industry, regulatory, device and biologic product trends relevant to the GSK portfolio. The Scientific Leader may also support due diligence projects and other biologic or device functional workstreams as required. This role reports to the head of BioPharm Product Sciences and Device Engineering. Job purpose and key responsibilities: Facilitate functional preparation and planning for drug product sections of regulatory dossiers for clinical trial and marketing applications. Conduct cross-functional review of regulatory submissions to ensure alignment of DP sections with the broader document. Review and advise functional representatives on product-related responses to questions from health authorities. Monitor and consolidate regulatory feedback and lessons learned from submissions and regulatory questions for specific projects. Communicate key trends/learnings within the drug product development line, which includes formulation, process and device development. Support authors and collaborate with product and device development SME's to align on DP strategy and ensure readiness of DP sections of submission Contribute to establishment and management of DP sections of regulatory templates and drive usage across BioPharm Product Sciences and Device Engineering Maintain communication in a nebulous and rapidly moving environment. Conducts activities in accordance with GSK policies, laws, quality standards, SOPs, etc. Develops strong, collaborative relationships with other departments/groups and fosters an environment of knowledge sharing. May be accountable for drug product-related due diligence activities and author reports. Direct authoring and other general biologics drug product support may be needed. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: M.Eng., M.S. or related degree with experience in medical devices combination product development; Ph.D. in Pharmaceutics or related science; post-doctoral or other experience in drug delivery or drug product development 10+ years or more of relevant experience with end-to-end drug product development and/or specialization in device-integrated products. Experience with biologics drug product development for IV, SC and device-integrated products. Experience with antibodies, recombinant proteins, antibody-drug-conjugates, fixed-dose-combination products and drug-device combination products. Significant experience in dossier development/support and submissions for biologic drug products through commercialization. Experience with regulatory interactions in US, EU, Japan and China. Experience working in a complex matrix environment and to influence and lead others without hierarchical authority. Experience authoring of due diligence reports and preparation of materials/recommendations for review by senior management. Preferred Qualifications: If you have the following characteristics, it would be a plus: Expertise in the development of combination products and knowledge of device regulatory requirements. Experience with the development of device-integrated products for biologics, small molecules and other modalities. Experience in life-cycle-management/product enhancement. Excellent relationship building, influencing and organizational and project management skills. Understanding of Drug and Food GMPs as well as familiar with FDA, European and global regularity requirements, such as ICH. Experienced in negotiating and agreeing timelines and milestones with sponsors/ business partners and continually monitoring progress to ensure timely delivery. Skilled communicator/presenter. 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. 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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