Manager Process Engineering
Site Name: USA - Pennsylvania - King of Prussia, USA - Massachusetts - Waltham Posted Date: Jul 16 2021 The Manager, Process Engineering will join a cross-functional team of scientists/engineers responsible for the process development and manufacturing of biologics programs within the Strategic External Development (SED) organization. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Provide support for biologics drug substance manufacturing process tech transfer and scale-up; monitor biologics drug substance manufacturing operations to identify, assess, and implement opportunities for process improvement. As a technical leader and subject-matter expert (SME) for onsite GMP manufacturing support, collaborate with applicable functional area personnel, assess and resolve technical issues that arise during biologics drug substance manufacturing operations. Serve as a SME for process engineering and validation during regulatory agency inspections. Serve as SME for department and company on the development or evaluation of technical concepts and methodologies, new unit operations, data analysis techniques and tools, risk management evaluations/assessments. Oversee process automation and equipment validation activities as related to biologics drug substance manufacturing. Review and approve applicable product batch documentation, including batch records, testing data, change controls and deviations. Collaborate with internal stakeholders and smoothly transition commercial manufacturing responsibility to internal commercial manufacturing organization. Why You? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: 5 years of experience in biologics drug substance development in biotech or pharmaceutical industry with significant experience in the areas of cell culture, protein expression, isolation, purification and characterization. Bachelor's degree in Engineering, Biology, or Biotechnology degree Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced degree in an appropriate technical discipline Strong knowledge of biologics manufacturing Experience working with external contract manufacturing partners. Demonstrated project management capability Proficiency with MS Office applications; advanced knowledge of Excel and MS Project desired Excellent written and oral communication skills, including the maintenance of technical data and reports; proactive collaboration 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. This position will require the candidate to be on-site at our external partner facilities during critical processing operations. There is an expected domestic and international travel amount of up to 25%. 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. 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