Global Head Analytical Immuno & Cellular Platform
Site Name: USA - Maryland - Rockville Posted Date: Jul 13 2021 As the Global Head Analytical Immuno & Cellular Platform, you will have the opportunity to lead a team of 5-6 Senior Managers & 60-70 scientists, located in Rockville US, Siena Italy and Rixensart,-Wavre Belgium, developing immune and cellular analytical tools for candidates vaccines from early development to commercial launch and develop immune and cellular techniques for a broad vaccines portfolio covering proteins expressed by pathogens, E-coli and CHO platforms, protein-polysaccharide conjugates, attenuated and live viruses, adeno vectors, mRNA based vaccines, etc… These responsibilities allow to progress YOUR career and include some of the following… Strategy and Direction Develop and implement best-in-class analytical immuno and cellular tools to assess rapidly the potency and safety of candidate vaccines Influence vaccine candidates selection with the Early Discovery R&D groups Define a phase appropriate strategy covering the Early vaccine candidate up to commercial Launch based on QbD (Quality by Design) principles Align with FDA & EMA expectations and international guidelines on the control strategy for candidate vaccines in clinical phases I, II and III and commercial launch leading to successful CMC file approvals. Lead and align practices from US, Italian and Belgian centers. People Management and Development Coach and lead analytical team leaders with an enterprise mindset from the US, Italian and Belgian centers. Set up an organization with best in class Subject Matter Experts Engage with stakeholders (Quality, Regulatory, Commercial QC, Technical R&D) to ensure effective collaborations and successful project outcomes R&D pipeline Influence vaccine candidates selection with the Early Discovery R&D groups Manage project priorities and foster smart risk taking to allow acceleration of vaccine development Innovation Connect with experts internally in GSK (Vaccines and Pharma) and externally with academics to develop state of the art techniques. Develop immune and cellular techniques for a broad vaccines portfolio covering proteins expressed by pathogens, E-coli and CHO platforms, protein-polysaccharide conjugates, attenuated and live viruses, adeno vectors, mRNA based vaccines, etc… External influence Influence international guidance drafting Connect with authorities on specific analytical matters related to submission files Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: MS 10 plus years of experience in biologics. 5 plus years of experience in managing people Experience with regulatory and GMP requirements Preferred Qualifications: If you have the following characteristics, it would be a plus: PhD Remote management experience. Strong influencing and communication skills with an understanding of the cross-functional facets 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. 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.