The Associate director MSAT will serve as the technical lead and site product owner for a biopharmaceutical product manufactured at the Rockville site. This individual will lead a team to support technology transfer of new products, product lifecycle management of existing commercial products, campaign readiness, and technical support for manufacturing. This individual will help develop strategy for biopharmaceutical products with Rockville, aligning with central teams and technical brand leads.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Manage and lead the technical program for a biopharmaceutical asset or value stream, including product Lifecycle Management (Technical Risk Assessment, Product Control Strategies, Continued Process Verification, Process Robustness Assessment), New Product Introduction and Technical Transfer to other sites/third party manufacturers.
• Oversee product technical lifecycle management with regards to process/yield improvement, process knowledge management, batch deviations, and ensuring accuracy of regulatory CMC registered detail. Ensure technical documentation is accurate and updated appropriately.
• Manage and facilitate the Continued Process Verification (CPV) programs for products manufactured at the Rockville site.
• Provide technical leadership for the rapid resolution of technical issues impacting supply through and product performance investigations through use of root cause analysis (RCA) tools and appropriate Corrective and Preventative Actions (CAPA) and escalate key site technical issues to the wider GMS technical community for timely resolution.
• Act was the primary technical representative on the technology transfer team for the transfer of DS biopharmaceutical production processes and technologies from R&D, third party clients, or MSAT labs to/from Rockville BioPharm.
• Serve as part of the GSK technical community, providing input to technical discussions and cross-site collaborations.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor of science degree in Biology, Chemistry, Bioengineering or other scientific discipline.
• 5+ years of industrial experience in technology/biopharmaceutical process development, technical project management and process transfer to production in a biopharmaceutical/biotechnology manufacturing environment.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Master of science degree in Biology, Chemistry, Bioengineering or other scientific discipline.
• Knowledge of current GMP's, ICH Guidelines and FDA/EU validation practices for biopharmaceutical processes required.
• Demonstrated experience / examples of process improvements / knowledge of manufacturing.

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 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.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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