Senior Manager/Associate Director
1 week ago
Are you a skilled professional looking to leverage your technical expertise and build exceptional relationships with global partners to develop transformative medicines for patients? This Senior Manager, Sterile DP role in a rapidly growing Strategic External Development organization at GSK could be an ideal opportunity to explore.
Key Responsibilities
- Contribute to the internal and external development of the company's specialty drug products and/or development of SED's internal processes.
- Provide leadership, working with internal and external partners, to ensure scientific excellence in biopharm/oligonucleotide preformulation and formulation study design, data collection and interpretation, process development, and management within scope to prospectively agreed objectives, budget and timelines.
- Manage multiple drug product development and manufacturing efforts for sterile drug product programs within GSK's development portfolio, including biologics, ADCs, and oligonucleotides.
- Build strong relationships with CMOs and internal stakeholders to facilitate the delivery of DP objectives.
- Support clinical supply manufacturing, batch record development, deviation management, change control implementation, CAPA ownership/support and technical investigations as needed.
- Assist project management to proactively build detailed CMC timelines providing technical clarity, project risks, resourcing and decision points.
- 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.
Requirements
- BS or MS/PhD in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, Materials Science or related scientific discipline.
- 8+ years of experience with BS/MS degree or 5+ years of experience with PhD degree for Senior Manager level role.
- Experience in sterile drug products, sterile manufacturing process development and execution, and vendor management.
- Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partner sites.
Why GSK?
At GSK, we unite science, technology and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology).
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