Associate Director or Director, Sterile Product Development
Site Name: USA - Massachusetts - Waltham Posted Date: Jul 1 2021 Are you looking for an impactful role that leverages your technical expertise/ leadership and ability to build exceptional relationships with trusted global partners to develop an increased number of transformative medicines for our patients? If so, this Associate Director/Director, Sterile DP role in a rapidly growing, empowered, innovative and agile Strategic External Development organization developing transformative medicines within a vibrant GSK Waltham hub could be an ideal opportunity to explore. As an Associate Director/Director, Sterile DP, you will contribute to/ lead 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/ all 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/process validation 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. Conduct and support technical due diligence and onboarding of CDMOs and CMOs domestically and internationally. Help to plan clinical production batches and to support commercial launch Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS (minimum), or MS/PhD (preferred) in Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline required. Pharmaceutical industry experience in biologics sterile product development and manufacturing 10 years of experience with BS/MS degree (Associate Director) 8+ years of experience with PhD degree (AD) 12 years of experience with BS/MS degree or (Director) 10+ years of experience with PhD degree (Director) Experience with vendor management. Requires a flexible work schedule to accommodate program priorities and international activities. International travel will be required. Preferred Qualifications: Demonstrated knowledge, experience, and successful track record in the full breadth of development, from pre-clinical to late stage manufacturing and commercialization of biologic sterile drug products is required. Demonstrated capability to lead multiple external product development projects is required. Demonstrated knowledge and experience in aseptic DP manufacturing for the manufacture of sterile drug product. Demonstrated knowledge and experience in drug product facility design, environmental controls and maintenance for the manufacture of sterile drug product. Experience with different mixing and filling technologies and platforms. Experience in early stage, late stage development and the commercial manufacture of drug product. Experience with both conventional and single-use DP processes. 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 required. 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 manufacturing process is highly preferred. Experience with end to end manufacturing processes is highly preferred. Experience with sterile manufacturing and drug product manufacturing is required. 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. *LI-GSK GSKBiopharm_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. *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. 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