Senior Manager/Associate Director

Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - King of Prussia Posted Date: Jul 27 2021 The Manager/Senior Manager/Associate Director, Early Stage Cell Line/Cell Bank/Cell Culture 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 cell generation, cell banking/testing and early stage cell culture development for multiple biologics programs. She/he will be expected to represent GSK at scientific and regulatory meetings as needed. Specific Accountabilities: Provide technical leadership, management and oversight on CDMOs for: Development of stable mammalian cell lines and establishment of cell banks for GMP manufacturing. Cell bank testing to support cell bank release Early stage cell culture development and optimization in parallel with final clone selection to establish robust upstream processes for earlier non-clinical and clinical usage. There is ample room for greater responsibility as the programs move to the late stage. The responsibilities of this individual will potentially include late stage upstream process development and characterization of robust upstream manufacturing processes based upon quality by design (QbD) principles, tech transfer, scale-up and manufacture of biologics drug substance at commercial scale and preparation for commercial launch. 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: Senior Manger: Ph.D. in (bio)chemical engineering, biochemistry or closely related field with 5+ years or MS with 8+ years relevant experience. Manger: Ph.D. in (bio)chemical engineering, biochemistry or closely related field with 2+ years or MS with 5+ years relevant experience. Experience in cell line generation and cell banking/testing. Experience managing projects and work with cross-functional teams comprised of internal and/or external contacts. Experience working with cGMP regulations. Experience in preparing CMC documentation for regulatory submissions. Ability to travel, not to exceed 20% (domestic and international). Preferred Qualifications: If you have the following characteristics, it would be a plus: 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. Budgeting and cost-consciousness *LI-GSK gskbiopharm_development 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. 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