Senior Manager, Upstream Process Development
Site Name: USA - Massachusetts - Waltham Posted Date: May 19 2021 The Senior Manager, Upstream Process Development (Biologics) will work within a cross-functional team environment, supporting GSK's biologics leadership team in defining and executing against short-, intermediate- and long-term strategic goals for all biologics programs. Specifically, under minimal guidance, the incumbent will be responsible for developing and executing CMC goals for upstream process development for multiple biologics programs. The successful candidate will be expected to represent GSK at scientific and regulatory meetings as needed. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Provide technical leadership, management and oversight for: Development of stable mammalian cell lines and establishment of cell banks for GMP manufacturing. Development, optimization and characterization of robust upstream manufacturing processes based upon quality by design (QbD) principles. Tech transfer, scale-up and manufacture of biologics drug substance to support nonclinical studies and clinical evaluation. Prepare CMC documentation for regulatory and/or patent filings. Establish and maintain an understanding of current trends and emerging cell line and upstream process development technologies Set clearly defined goals/objectives to ensure delivery of high-quality results. Provide clear communication to CMC teams and functional line management regarding progress against technical objectives/milestones. Ensure well-organized, clear and complete documentations of all activities across areas of responsibility. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Ph.D. in (bio)chemical engineering, biochemistry or closely related field with 5+ years or MS with 7+ years relevant experience. Experience in upstream process development from early phase cell culture process development to late stage cell culture process characterization study. Experience with managing projects and working with cross-functional teams comprised of internal and/or external contacts. Experience building relationships and working with CDMOs. Experience with cGMP regulations. Experience in preparing CMC documentation for regulatory submissions. Preferred Qualifications: If you have the following characteristics, it would be a plus: Ability to travel, not to exceed 20% (domestic and international). Excellent written and oral communication skills, including the maintenance of technical data and reports; proactive collaboration in a multi-disciplinary business and science team environment is essential. Personal attributes: self-starter; attentive to details; accountable; committed while maintaining balance and perspective. Others will describe you as honest, trustworthy, and respectful of others; a person of high integrity, a good listener, a straightforward communicator, and a team builder. Ability to work in a fast-paced and dynamic corporate environment with changing priorities, and flexibility to support multiple development programs simultaneously. Ability to solve the problems using innovative thinking and good decision making. Ability to lead innovation, change and drive for results. Experience in managing technical teams and external partners Strong collaboration and communication skills; ability to build and maintain strong ties with internal and external stakeholders. 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: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. 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