Senior Manager or Associate Director, Sterile Product Development
Site Name: USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham Posted Date: May 10 2021 Are you looking for an impactful role that leverages your technical expertise and ability to build exceptional relationships with trusted global partners to develop an increased number of transformative medicines for our patients? If so, this Senior Manager/Associate Director, Sterile DP role in a rapidly growing, empowered, innovative and agile Strategic External Development organization developing transformative medicines within a vibrant GSK hub could be an ideal opportunity to explore. As a Senior Manager, Associate Director, Sterile DP, you will contribute to internal and external development of the company's specialty drug products and/or development of SED's internal processes. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Manage multiple drug product development and manufacturing efforts for sterile small molecule and/or biologics drug product programs within GSK's development portfolio. Build strong internal and external relationships with key stakeholders to help facilitate the delivery of DP objectives. Facilitate a highly cross-functional internal and external CMC team environment through engaged leadership, collaborative interactions and a data driven, quality focused mentality. Provide direction and oversight for process development/scale-up/transfer activities at external development and manufacturing sites. Provide leadership to ensure scientific excellence in study design, data collection and interpretation, and management within scope to prospectively agreed objectives, budget and timelines. Provide critical analysis of program challenges and opportunities and recommend mitigation plans where necessary. Support/lead clinical supply manufacturing, technology transfer, process qualification, change control implementation and technical investigations. Assist project management to proactively build detailed CMC timelines with clarity to assumptions, risks and decision points. Prepare and keep current written CMC development strategies in alignment with overall program objectives. Presents results and progress of CMC programs to internal and external audiences as appropriate. Develop and document the knowledge base needed for regulatory filings. Provide subject matter expert scientific review of CMC sections of regulatory documents. Why you? We are looking for professionals with these required skills to achieve our goals: Demonstrated knowledge, experience, and successful track record in development, late stage manufacturing and commercialization of biologic sterile drug products is required. Demonstrated capability to lead multiple external product development projects is required. Working knowledge of FDA/ICH/EMA guidelines and cGMPs, phase-appropriate development strategies across IND-NDA/BLA stages and global requirements for IND, NDA, and BLA submissions (or their regional equivalents) is required. Experience with IND/BLA/MAA writing and/or review is highly preferred. Working knowledge of the interrelationships between formulation, process development and drug delivery and an understanding of how preclinical, clinical, and commercial drivers affect the development pathway of drug candidates from research through life cycle management is highly preferred. Experience with Quality by Design (QbD) and Design of Experiment (DoE) studies to assess robustness and optimization of attributes of drug product formulation and/or manufacturing process is highly preferred. Experience with manufacturing of challenging compounds/products is highly preferred. Experience with lyophilized product manufacturing is highly preferred. Experience with small molecule sterile and/or drug product manufacturing is preferred. Strong technical/analytical skills to identify and solve problems are required. Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partner sites are required. Strong organizational skills in order to maintain a high level of productivity, innovation, and setting priorities in order to complete assignments in a timely manner and within budget are required. Exhibits high initiative, strong drive and follow-through. Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS (minimum), MS/PhD (preferred) in Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline required. Minimum pharmaceutical industry experience in biologics sterile product development and manufacturing 8 years of experience with BS/MS degree or 5 years of experience with PhD degree for Senior Manager level role 10 years of experience with BS/MS degree or 8 years of experience with PhD degree for Associate Director role 8 years of experience with vendor management. Preferred Qualifications: Requires a flexible work schedule to accommodate program priorities and international activities. International travel will be required. 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. 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