Associate Director, Product Owner Lead

Here at GSK, Product Owners are the single point of accountability for product lifecycle and CMC strategy/ execution for the biopharmaceutical assets manufactured at the commercial Rockville facility. In this role, as an Associate Director, Product Owner Lead you will be leading a team of product owners accountable for establishing and updating control strategy, identify continuous process improvements and drive CMC Submissions and agency interactions.

The individual will work in a highly cross-functional matrix environment and will lead product owners' team to develop strategy for complex global CMC submissions and drive on time execution.

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

• Coach and mentor a team of product owner; drives technical agenda and develop capabilities
• Ensure products have appropriate control strategy and makes update as necessary
• Main accountable for authoring CMC dossier and HAQs for US and ROW markets
• Ensure content of CPV report, protocols and annual PPR is strategically appropriate and accurate
• Provide oversight and guidance to CPV meetings
• Identify opportunities for continuous improvements
• Works cross-functionally with Global Molecule Stewards, Global Regulatory and Global Quality parters, as well as internal site functions
• Provide strategical oversight to a variety of CMC and LCM activities

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

• Bachelors degree
• 10+ years industrial experience in Biopharmaceutical process development, MSAT or CMC roles
• Experience with current trends in the industry, ICH Guidelines and GMP principles at commercial scale
• Experience in CMC technical writing field with complex regulatory submission and response with a variety of Regulatory Agency (FDA, EMA, JP, China etc.)
• Prior regulatory experience required, authoring and approving complex submissions and supporting agency interactions
• Strong understanding and experience with Process Validation and Control strategy
• Experience working within bioprocesses for DS (upstream and downstream)
• Prior experience supporting inspections and audits

Preferred Qualifications:

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

• PHD highly preferred
• Strong sense of urgency, ability to work under pressure and questioning status quo
• Ability to challenge status quo, design new ways of working
• Demonstrated ability to deliver complex projects end-to-end
• Ability to manage cross-functionally a variety of stakeholders, influence and drives decisions
• Demonstrate ability to work in a cross-functional, matrix environment and understanding of governance roles
• Strong executive presence and executive presentation skills are required in this role
• Strong interpersonal and leadership skills. Committed team player prepared to work in and embrace a team-based culture.
• Ability to challenge status quo and identify new solutions and ways of working
• Able to interact cross-functionally within the site and with multiple stakeholders out of the sites, in and out of GSC organization (GRA, global compliance etc.).
• Outstanding verbal and written communication skills which emphasize teamwork with a strong quality orientation.
• Demonstrated technical CMC writing skills.
• Thorough understanding of bioprocesses for DS manufacturing
• Demonstrated experience with commercial manufacturing, NPI and commercial launches
• Strong leadership skills and executive presence

#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 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 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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