Senior Manager, Sterile Drug Product Operations

We are building a state-of-the-art end to end Biopharm capability which delivers efficient discovery of antibody 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! Click here to know more about GSK Biopharm. #GSKBiopharm_Development 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 Sr Manager, Sterile DP 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 Senior Manager, 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 manufacturing efforts for sterile biologics drug product programs within GSK's development portfolio. Build strong relationships with CMOs/ CDMOs Contribute to technical due diligence in the selection of CDMOs/ CMOs Build strong internal and external relationships with key stakeholders (e.g. analytical, drug substance, internal manufacturing groups, project management, project coordinators) 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 critical analysis of program challenges and opportunities and recommend mitigation plans where necessary. Collaborate with multidisciplinary development, SMEs and quality functions to achieve product/process deliverables. Support clinical supply manufacturing, change control implementation and technical investigations as needed. Assist project teams with CMC timelines . Prepare and keep current written CMC development strategies in alignment with overall program objectives. Present results and progress of CMC programs to internal and external audiences as appropriate. Support knowledge management strategies and execution needed for regulatory filings and a commercially viable drug products. 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 a successful track record in sterile manufacturing process development of biopharm, oligonucleotide or sterile drug products is required. Experience with Quality by Design (QbD) and Design of Experiment (DoE) studies to assess robustness and optimization of attributes of manufacturing process is required. Demonstrated capability to lead multiple external product development projects is 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. CMO manufacturing experience is a plus. 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 highly preferred. Experience with IND/BLA/MAA writing and/or review is highly 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. Exhibits high initiative, strong drive and follow-through. Job Requirements Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS in Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline required. 8+ years of pharmaceutical industry experience in sterile drug product manufacturing process development. Experience with Quality by Design (QbD) and Design of Experiment (DoE) principles. 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). Experience with CDMO management and oversight. Excellent cross-functional management and leadership skills. Demonstrated capability to effectively manage multiple projects. Strong critical thinking and decision-making skills, interpersonal and communication skills, ability to work within a multidisciplinary matrix team. Agility, courage to take smart risks, accountability. Requires a flexible work schedule to accommodate program priorities and international activities. International travel will be required. Preferred Qualifications: MS/PhD in Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline 5+ years of pharmaceutical industry experience in sterile product manufacturing process development including mAbs, ADCs, small molecules, oligonucleotides or vaccines. Experience with different mixing and filling technologies and platforms; both conventional and single-use DP processes. Experience with lyophilized products, prefilled syringes and/or combination products. Demonstrated knowledge and experience in drug product facility design, environmental controls and maintenance for the manufacture of sterile drug product. Demonstrated knowledge and experience in manufacturing process development, from pre-clinical to late-stage manufacturing, technology transfer, process qualification and commercialization of biologic sterile drug products. Experience with IND/IMPD/NDA/BLA/MAA submissions, responses to questions (authoring and/or review). Familiarity with an ability to anticipate industry trends and emerging issues. 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, rigor and risk Managing individual 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. 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