Manager/Senior Manager- Oral Product Development
Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Nov 17 2021 We are building a state-of-the-art end to end externally focused strategic development group which delivers efficient discovery of molecules that are selected and engineered for rapid development so that, together with our therapy area partners, we discover, develop and manufacture novel portfolio of exciting medicines to benefit patients around the world. If you aim to be part of a global cutting edge drug development and discovery organization and are motivated to contribute towards bringing lifesaving drugs to patients, join us! 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 Manager/Sr Manager Oral Product Development role in a rapidly growing, empowered, innovative and agile Strategic External Development organization developing transformative medicines within a vibrant GSK Boston hub could be an ideal opportunity to explore. As a Manager/Sr. Manager Oral Product Development, you will contribute to internal and external development of the company's oral drug products. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Manage drug product development and manufacturing efforts for Oral small molecule 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 product and process development/scale-up/transfer activities at internal and external 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 clinical supply manufacturing, 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? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Senior Manager BS in Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline with 8+ years of pharmaceutical industry experience in small molecule, oral drug product, or sterile liquid development and manufacturing; MS/PhD in, Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline required with 5+ years of experience Manager BS in Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline with 5+ years of pharmaceutical industry experience in small molecule oral drug product or sterile liquid development and manufacturing; MS/PhD in, Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline required with 3+ years of experience. Knowledge, experience, and successful track record in development and commercialization of small molecule drug products. Experience leading internal and external product development projects. 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. 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. Knowledgeable of FDA/ICH/EMA guidelines and cGMPs, phase appropriate development strategies across IND-NDA stages and global requirements for IND and NDA submissions (or their regional equivalents) Preferred Qualifications: Experience with vendor management. Experience with drug delivery strategies of challenging compounds and/or sterile drug products. Sterile liquid drug product experience. Strong technical/analytical skills to identify and solve problems. Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partner sites. 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. Exhibits high initiative, strong drive and follow-through. Requires a flexible work schedule to accommodate program priorities and international activities as needed. Travel (some international) will be required. Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. 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