Director, 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 to know more about GSK Biopharm. #GSKBiopharm_Development 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 Director, Sterile DP Operations 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. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some/ all of the following: Conduct technical due diligence and onboarding of CDMOs and CMOs domestically and internationally. Oversee and facilitate implementation of new technologies and capabilities at external partner sites. Develop and/or streamline internal processes, procedures and establish best practices in support of product development acceleration strategies. Provide guidance, mentoring and coaching to junior team members. Manage drug product development and manufacturing efforts for sterile small molecule, oligonucleotide and/or biologics drug product programs within GSK's development portfolio. Build strong internal and external relationships with key stakeholders. 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. Why you? 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. 12+ years of pharmaceutical industry experience in sterile product development and manufacturing. 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. Requires a flexible work schedule to accommodate program priorities and international activities. International travel will be required. Preferred Qualifications: If you have the following characteristics, it would be a plus: MS/PhD in Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline 15+ years of pharmaceutical industry experience in sterile product development and manufacturing, including mAbs, ADCs, small molecules, oligonucleotides or vaccines. Excellent management and leadership skills; ability to recruit, retain and develop talent. 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. 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, experience, and successful track record in the full breadth of 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. *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. 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. At GSK, the health and safety of our employees are of paramount importance. 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