Senior Manager - Vaccines Drug Product Development
Site Name: USA - Maryland - Rockville Posted Date: Oct 12 2021 The Sr. Manager is expected to manage a group to design and execute scientific studies in support of technical development programs as they progress from discovery and early development into Phase I/ II, Phase III, technology transfer and process performance qualification at the intended commercial site, including post-authorization line extensions and/or product & process optimization. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Manage/organize a group to designs and leads specific development workstreams autonomously, in line with business priorities, following the Quality by Design framework. Resource adequately projects and programs with employees with appropriate strategy via insourcing or outsourcing Accountable for all transversal aspects such as Process Control and Data Archiving, DoE plan and Mathematical Modelling. Lead external collaborations. Accountable for disruptive innovation in collaboration with internal experts and/or in partnership with external companies and institutions. Identify risks on developability, process feasibility or manufacturability, timing and resources constraints and seek a remediation plan for identified risks and escalate any technical issues to the Technical Development Team and other relevant bodies. Lead PhI/II and PhIII process transfer to Pilot Plant to ensure efficient production of PhI/II or PhIII clinical grade material. Bring scientific expertise and give technical support to Pilot Plant managers during GMP campaigns. Ensure process knowledge continuity, through Core Team, from early to late development, PhIII clinical lots production and up to first commercial lots manufacture in GIO. Develop an end-to-end vision of the process development in order to fulfil all the requirements in alignment with manufacturing constraints. Develop people in order to integrate early and late development activities and promote an efficient and innovative working environment. Harmonize technology, development approaches, documentation, process history file, between early and late development. Perform technology and patent watch for maintaining innovation and up-to-date technology for developing new vaccine projects. Prepare and presents scientific data within Technical R&D including Technical Development Team and may represent GSK externally (conferences, etc). Communicate effectively within TRD and with external stakeholders and is able to defend scientific and technical decisions at the appropriate boards. Operate at the interfaces with Preclinical R&D for early stage programs or with GIO/MSAT for late stage and post-authorization programs Benchmark specific technologies in own functional area to bring technology to state of the art. Contribute to and drive strategy and technical development planning and accountability in the execution thereof. Ensure execution of the function's risk assessment and escalate at relevant bodies. Development of mitigation plans. Act as a voice and ambassador of its department at various governance bodies / meetings. Lead and implement the respect of the GxP / EHS / QA rules application. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field with 3+ years of post-doc and/or job-related experience, or MS with 6+ years of experience, or BS with 9+ years of experience Experience with biopharmaceutics and/or vaccine early and late-stage process development required Extensive knowledge of processes and unit operations used to manufacture biopharmaceuticals and/or vaccines required Extensive knowledge of, and practical experience with, pharmaceutical lyophilization required Extensive knowledge of the preparation and preservation of liposomes and/or lipid-based delivery vehicles required Extensive knowledge of the development of protein antigen-based vaccines Extensive knowledge of sterile drug product manufacturing Extensive knowledge of drug product formulations and associated technologies Excellent presentation, interpersonal and communication skills Preferred Qualifications: If you have the following characteristics, it would be a plus: Ability to effectively manage a team of dedicated scientists Ability to work with cross-functional teams and in matrix environments Competency to influence scientific and technical vision and strategy Must be able to work with individuals having different cultures/values Experience in technology transfer in manufacturing is a plus 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 #careersinvaccines VxRD* 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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. 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. 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