MSAT Product Owner 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 Product Owner 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 areachieved. 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 MSAT Product Owner Associate Director, will lead a team of product owners to support the portfolio of clinical and commercial programs for Upper Merion. Product Owners are the single point of accountability for technology transfer, product lifecycle, CMC strategy, and technical execution for the biopharmaceutical assets manufactured Upper Merion. The individual supports the team to manage new product introduction, QbD, control strategy, and CPV development and maintenance, CMC dossier authoring and health authority questions, and technical product strategy and process efficiency / continuous improvements. The individual is also expected to drive continuous improvement in these spaces, aligning with platform standards and integrating digital solutions.

In addition, this individual will be expected to work in a cross-functional matrix environment, including stakeholders in other departments within UM biopharm (i.e. production, quality, engineering), and global MSAT, R&D, global regulatory, and global quality.

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

• Serve as the Upper Merion lead for a team of site product owners for clinical and commercial programs
• Drive the delivery of right-first time new product introduction and commercial lifecycle management, including CMC regulatory file authoring and health authority questions
• Support the delivery of the technical documentation package to support product validation including validation and verification plans, technical reports / protocols, regulatory filings, and PAI readiness documentation
• Lead the CPV strategy for the site, ensuring CPV and PPR programs are aligned to regulatory expectations and provide value to the business
• Drive innovation, digital tool implementation, and continuous improvement for PLM approaches, utilizing CoPs and industry forums to stay current on regulatory guidance and industry trends
• Develop and provide training for MSAT team members on PLM / PV concepts

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 process validation, process development, technology transfer, and product lifecycle management. Strong understanding of bioprocesses for drug substance (upstream and downstream)
• Demonstrated skillset in CMC, including complex regulatory submission and response with a variety of regulatory agencies (FDA, EMA, JP, China etc.)
• Understanding of GMP principles, regulatory submissions, and appropriate regulatory guidance
• Strong verbal and written communication skills. Ability to interact with and influence across the entire MSAT organization
• Strong executive presence and executive presentation skills
• 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 and challenge status quo

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.

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. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/