MSAT Standards and Contamination Control Associate Director

At GSK, we manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.

We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

We are looking to hire a MSAT Standards and Contamination Control Associate Director to join the Manufacturing Science and Technology (MSAT) organization in Upper Merion. This 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.

In this role, you will lead a team to develop technical standards and processes, in alignment with central teams in topics including contamination control, single-use systems, lifecycle management, cleaning validation, leachables and extractables, and cell banking. This individual and their team are expected to become subject matter experts to provide in-depth technical support to resolve challenges, implement best practices, and support process improvements. The individual will also lead cell bank management at Upper Merion, supporting the inventory management, transfer, and technical oversight of the Upper Merion cell bank portfolio.

The MSAT Standards and Contamination Control Associate Director will also be expected to develop systems and processes to develop a technical capable, motivated, and energized MSAT team. You will be accountable supporting technical and leadership capability development, with a focus on the future skills the MSAT team will be to develop to be successful and solve complex technical issues. You will be expected to manage within a matrix team, collaborating with team members from other UM Biopharm departments and with stakeholders global MSAT.

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

• Lead a team of technical experts across key disciplines including contamination control, single-use systems, cleaning validation, lifecycle management, leachables and extractables, and cell banking. In alignment with global MSAT, develop and maintain the technical standards in these areas for Upper Merion
• Serve as a technical enterprise leader across the Upper Merion site, to support investigations, global initiatives, risk assessments, technology transfers, and regulatory / audit across these key areas of responsibility
• In alignment with global MSAT, define the approach and strategy for the team, including staying current on industry trends and best practices
• Manage the Upper Merion cell bank portfolio and key cell bank activities and documentation
• Manages relationships with key internal (i.e. production, engineering, quality) and global teams, including a strong partnership with global MSAT technical standards team

Why You?

Basic Qualifications:

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

• Bachelors with a minimum of 8 years OR a Masters (MS) degree with a minimum of 5 years OR PhD with minimum of 3 years of post-graduate experience in the biopharmaceutical or pharmaceutical industry
• Experience in biopharmaceutical or vaccines technologies, research & development and/or manufacturing

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 bioprocesses for drug substance (upstream and downstream, including large scale cell culture bioprocessing and  biopseparations and purification technologies
• Deep understanding of current trends in the industry, ICH guidelines, and GMP principles, particularly in the fields of contamination control, single-use systems, and process validation
• Understanding of process validation, process development, technology transfer, and product lifecycle management
• Strong interpersonal and leadership skills to manage cross-functional teams. Ability to influence cross-functionally and drive improvements
• Strong verbal and written communication skills particularly in the area of technical and regulatory related matters

This role is on-site, offering opportunities to engage directly with teams and processes to make a tangible impact.

#Li-Gsk

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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