Biopharmaceutical Commercial Drug Product Development Director
Site Name: USA - Pennsylvania - Upper Providence Posted Date: Jul 23 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 Biopharmaceutical Commercial Drug Product Development Director is expected to lead a team of scientists that are expected to contribute to the fill and flow of GSK's biopharmaceutical R&D pipeline. The role ensures projects meet agreed timelines and budgets. It also manages resource prioritization as per agreed strategy. Specifically, your team will lead, execute and document Phase 3 enabling activities for investigational drug products. Your team will also develop manufacturing processes for these products and transfer them to commercial manufacturing sites. During transfer, you will scale up while ensuring cost effectiveness the process. Additionally, you will support due diligence activities, evaluating in-licensing or partnership opportunities. You will identify obstacles and propose remediation for these opportunities to senior management. You will also support regulatory submissions through cross functional review of submission document. Furthermore, you will contribute towards defining the Biopharmaceutical Commercial Drug Product Development organization's near-, medium- and long-term ambition (e.g., revisited every c.3 years) that is defined by internal demands and external trends and includes how to track and measure the progress towards the ambition. This role reports to the head of Biopharmaceutical Commercial Drug Product Development. You will need to collaborate with partners in CM&C development, such as Device Development, Bioanalytical Development, and Drug Substance Development. You will need to work across boundaries with GSK's Pharmaceutical Supply Chain. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Accountable for strong leadership, management, development, and oversight of the Team, providing direction and vision Translates the company vision, mission, and strategy into coherent plans/requirements that can be understood and implemented by staff. This includes ensuring the team understands and operates according to the appropriate business vision, regulatory requirements, and internal processes in order to ensure excellence in the delivery of studies and projects Conducts budget review and adjusts as needed (IPE and oversight of EPE), ensures robust budget forecast and management Ensures appropriate resource planning based on forecast workload, develops resource strategies also considering EPE resources, ensures effective resource utilization within the team Interacts effectively with stakeholders (internal and external) Actively engages with local industry partners and regulatory stakeholders to maintain and influence a positive operational environment Superior leadership skills with demonstrated ability to build and maintain highly efficient teams in complex environments. Superior communication and relationship building skills. In-depth knowledge of the drug development. Superior analytical skills and ability to think /frame problems strategically. Independent and pro-active individual able to implement adequate responses to situations without guidance; self-motivated and able to motivate and guide others. Able to work in ambiguous circumstances and take actions quickly while involving the right stakeholders in the right situation at the right time Provides leadership to the team to deliver robust, efficient, and valuable manufacturing processes. Provides leadership to the team and contributes to the Technical Risk assessment and the Control Strategy for new products. Proactively reports and communicates with key stakeholders utilizing proper tracking mechanisms that manage timelines and budget requirements. Ensures optimal utilization of resources. Ensures principals of Quality by Design (QbD),and Operational Excellence (OE) are appropriately utilized in the product development process. Develops strong, collaborative relationships with other departments/groups and fosters an environment of knowledge sharing. Participates in the identification, recruitment and retention of talent. Creates an environment that encourages both technical and leadership development and rewards appropriately. Sets high standards for individuals in key areas of technical activities and effectiveness. Provides opportunities for training, development and coaching/guidance when needed. Establishes an environment that supports and nurtures scientific understanding and innovation among the team. Ensures that team is highly motivated. Timely recognition of accomplishments and excellence in job performance, development opportunities, etc. Directs activities in accordance with GSK policies, laws, quality standards, SOPs, etc. Ensures that internal staff are working and maintaining labs in a safe manner and that housekeeping is maintained. Provides relevant input to budgeting process. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD. in Pharmaceutics or related science. 20 years of relevant, end to end drug product development experience. Expertise in biologics drug product development for IV, SC and device-integrated products. Familiarity with CGMP requirements. Authoring, review and approval BLA/MAA, IND/IMPD and other regulatory documents. Experience leading cross functional technical teams and developing strategic objectives/direction. Experience in conducting due diligence activities and onboarding/operationalizing DP development projects with external origin. Preferred Qualifications: If you have the following characteristics, it would be a plus: Demonstrated clear strategic capabilities acquired through experience. Experienced people leader with record of talent management and development. Ability to work in a complex matrix environment and to influence without hierarchical authority. Comfortable and skilled communicator/presenter. Project management experience Demonstrated expertise in the development of combination products. Excellent oral and written communication skills at all levels within the organization. Track record of coaching, mentoring, leading and developing people to build strong collaborative teams working in a high-performance environment in a culture that values scientific rigor and empowerment. External communication and/or network with regulators, external collaborators and/or scientific experts. Excellent relationship building, influencing and organizational and project management skills. Excellent 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. Deep understanding of Quality of Design (QbD), Operational Excellence (OE), Value Engineering/ Design to Value principles, scale up & Technology Transfer and how they apply in an R&D environment. Pre-Approval Inspection Experience Demonstrated expertise in the development of lyophilized products *LI-GSK GSKBiopharm_development 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. 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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