Associate Director/Senior Manager, Biopharm Drug Product Development
Site Name: USA - Pennsylvania - Upper Providence Posted Date: Aug 10 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 Associate Director will 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 clinical trial 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. 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. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: We are looking for professionals with these required skills to achieve our goals: · PhD. in Pharmaceutics, Chemical Engineering, Chemistry, Bioengineering, Engineering · 10 years experience of relevant commercial drug product development experience. · 3 years experience Biopharmaceutical industry experience more broadly. · 3 years experience in leading cross functional technical teams. · 1 year experience with cGMP requirements. · Authoring BLA/MAA submissions. Preferred Qualifications: If you have the following characteristics, it would be a plus: · Demonstrated clear strategic capabilities acquired through experience. · Ability to work in a complex matrix environment and to influence without hierarchical authority. · Comfortable and skilled communicator/presenter. · 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. · Pre-Approval Inspection Experience *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. 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.