Scientific Director - Biologics Drug Product Development and Submissions
Site Name: USA - Pennsylvania - King of Prussia, USA - Pennsylvania - Upper Providence Posted Date: May 28 2021 The Scientific Director, Biologics Drug Product Development and Submissions is expected to provide input into the development of biologic drug products and guide preparation of functional section of regulatory submissions. The Director will serve as a subject matter expect who works across BioPharm Product Sciences to coach authors to ensure appropriateness and consistency of content of the DP sections. The Director will provide oversight across DP portions of all submissions during preparation, review and response to health authority questions. The Director will ensure integration of lessons learned and regulatory trends into the product development strategies and plans for the biologics DP portfolio via influence of submission working groups, the BPSDE core management team, project teams and broader staff. The Director will maintain awareness of key industry, regulatory, drug-device combination product and biologic product trends relevant to the GSK portfolio. The Director will provide leadership and strategic direction to biologic product development teams during submission preparation and review as well as participate in broader CMC cross-functional review and approval. The Director may also support due diligence projects and/or other biologic drug product and device development workstreams as needed. Provide functional oversight of 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 challenges to ensure that lessons learned from submissions and regulatory questions for specific projects are embedded into the development strategies of other biologic drug products. Communicate key trends/learnings within the drug product development line, which includes formulation, process and device development. Establish authoring expectations and collaborate with DP SME's to align on DP strategy and ensure readiness of DP sections of submissions. Contribute to establishment and management of DP sections of regulatory templates and drive usage across BioPharm Product Sciences. May be accountable for conduct of biologics DP-facing due diligence activities. Maintain communication in a nebulous and rapidly moving environment. Navigate ambiguous circumstances and take actions quickly while involving the right stakeholders. Directs 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 implement change initiatives and/or lead change. Provide coaching/guidance when needed. Participate in the Core Management Team of BioPharm Product Sciences and Device Engineering and engage with peers/colleagues independently. May also conduct drug product-related due diligence activities and author reports. Other general biologics drug product support may be needed. This role reports to the head of BioPharm Product Sciences and Device Engineering. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD. in Pharmaceutics or related science; post-doctoral or other experience in drug delivery or drug product development. 10 years of experience in drug development Experience with end-to-end drug product development, spanning traditional and nonconventional biologics, inclusive of BLA submission. Experience in biologics drug product development for IV, SC and device-integrated products. Experience with antibodies, recombinant proteins, antibody-drug-conjugates, fixed-dose-combination products and combination products. Experience in dossier development/support and submissions for biologic drug products through commercialization. Experience with regulatory interactions in US, EU, Japan and China. Experience with device development and regulatory requirements. Experience working in a complex matrix environment 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: Skilled communicator/presenter. Experience influencing and leading others without hierarchical authority. Expertise in the development of combination products. 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. 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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