GSK is currently looking for a Sr. Process Validation and Lifecycle Management MSAT Manager to join our team in Upper Merion, PA. The Manufacturing Science and Technology (MSAT) organization is a site-based team, providing technical support to ensure Upper Merion Biopharm site goals and objectives are achieved.  The primary objective role of MSAT is to ensure manufacturing processes are capable, compliant and productive while ensuring product quality.  The site MSAT team is also responsible for delivering continuous improvements to the existing supply chains supported by UM Biopharm and working with global MSAT to execute technology transfers and implement process-related improvement programs across the product lifecycle.

The Senior Manager, MSAT Process Validation and Lifecycle Management, will serve as the Upper Merion site technical expert on technology transfer, process validation (PV), regulatory inspections and submissions, and product lifecycle management (PLM). This individual will own and support project teams to deliver key PV / PLM milestones across all stages of the product lifecycle. The senior manager will be expected to lead technical strategy for regulatory file writing, PAI readiness, and audit support within the MSAT team.  The senior manager will be responsible for staying current with lifecycle management strategy and driving continuous improvement, delivering step changes in process efficiency and embedding digital tools.

In addition, this individual will be expected to support technical capability development in the PV / PLM space for the site MSAT team. A senior manager is expected to manage within a matrix team, collaborating with team members from other UM Biopharm departments (i.e. production, quality, engineering) and with stakeholders in central MSAT, supply chain, and R&D teams.

Key Responsibilities:

• Serve as the Upper Merion site technical expert for process validation and product lifecycle management, owning the validation / PLM framework and strategy at Upper Merion to drive the delivery of right-first time new product introduction and commercial lifecycle management
• Deliver process validation documentation for biopharmaceutical assets including validation and verification plans, technical reports / protocols, regulatory filings, and PAI readiness documentation
• Drive innovation, digital tool implementation, and continuous improvement for PLM approaches, utilizing CoPs and industry forums to stay current on regulatory guidances and industry trends
• Develop and provide training for MSAT team members on PLM / PV concepts
• The senior manage may support the development of standards and processes in areas such as single-use systems and cell banking, in alignment with central teams.

Why you?

Basic Qualifications:

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

• BS/BA degree in either biological or chemical science or engineering or equivalent technical discipline with a minimum of 5 years of experience in the Biopharmaceutical/pharmaceutical industry OR MS or PhD degree with a minimum of 3 years of experience in the biopharmaceutical/pharmaceutical industry

Preferred Qualifications:

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

• Experience in biopharmaceutical technologies and/or manufacturing with a strong technical understanding of process validation, process development, technology transfer, and product lifecycle management.
• Understanding of GMP principles, regulatory submissions, and appropriate regulatory guidances.
• Strong verbal and written communication skills. Ability to interact with and influence across the entire MSAT organization.
• Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines. Embraces a team-based culture.
• Demonstrates initiative to solve problems.

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Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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. We prevent and treat