Manager Analytical Lifecycle Management
Site Name: USA - Pennsylvania - King of Prussia, USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence Posted Date: Oct 13 2021 At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realizing our purpose starts with us. When we feel at our best, we perform at our best. When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing. Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers. The Manager Analytical Lifecycle Management is responsible for and implements the GMP analytical life cycle from mid phase (pre-Commit to Medicinal Development) through commercialization of Biopharmaceutical products. Develop analytical method transfer/qualification/validation strategies between R&D, PSC and external contract testing laboratories. Supervises the implementation of the analytical contracts and relationships with external contract testing laboratories. Contribute to product specification development and ensure alignment with process/method capabilities, implement and leads the GMP specification. Reviews and/or approves regulatory submissions. Recruit, train and develop direct reports. The Manager Analytical Lifecycle Management will support the analytical work packages for the Biopharmaceutical portfolio including technical writing and data interpretation. Make strategic analytical decisions and partner management. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Develop a phase appropriate analytical coordinated strategy for method verification/qualification/validation and technology transfer between R&D, PSC and external contract laboratories/manufacturers Accountable for setting the strategy of GMP analytical work and leading all aspects of the transition of Biopharmaceutical assets from mid phase development into the GMP testing laboratory, through licensure and post-marketing requirements Work to establish and lead all aspects of the external contract laboratory testing capability to support the Biopharmaceutical pipeline Approve product specifications, certificates of analysis, analytical methods, method transfer/validation protocols and reports to ensure alignment with phase appropriate project requirements Author or review/approve templates, guidelines, SOPs, policies or project plans Review and/or approve regulatory submissions and associated RTQs Represent the GMP analytical strategy in internal/external project meetings Support regulatory inspections such as Product Approval Inspections, post-marketing commitments such as new method implementation, and new product formulations or DP presentations beyond licensure Recruit new employees and ensure direct reports are trained to perform their job Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree in Biotechnology, Chemistry, Biology or other scientific or technical field Bachelor's Degree and 10+ years of experience with analytical life cycle and operations OR Master's Degree and 8+ years of experience with analytical life cycle and operations OR Ph.D and 5+ years of experience with analytical life cycle and operations Ability to travel up to 10% Preferred Qualifications: If you have the following characteristics, it would be a plus: Significant knowledge of cGMP and Regulatory requirements for the development and commercialization of Biopharmaceuticals. Familiarity with FDA/EU/ICH regulations and guidance particularly as they relate to Analytical Testing Extensive knowledge of analytical method development, technical transfer and validation Coordinate several projects at different stages of development and may include commercial projects Excellent written/verbal communication, presentation and influencing skills Effective project management skills Applies technical knowledge to form new ideas, anticipates and recognizes potential problems whilst providing workable solutions and make decisions based on complex information or expertise from multiple specialty areas Acts as an internal subject matter authority in area of expertise Provide analytical information to support the project team decision making process Act as a QMS ambassador where required Ensures change management is followed for analytical methods and specifications Present at internal meetings and may present information at external meetings As a manager of direct reports Coach/mentor to achieve full potential Sets goals and assigns tasks Manages performance and develops performance plans Conducts performance appraisals and makes recommendations for advancement and development 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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