Here at GSK, CMC Product Leads 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, you will be accountable for authorizing complex CMC regulatory submission, sustain agency interactions as well as supporting overall product lifecycle management and process improvements initiatives.

As a CMC Product Lead, you will work in a highly cross-functional matrix environment and will support the product owner team lead 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:

• Ensure product has an appropriate control strategy (technical RA, PAR/ NOR), propose revisions and updates as necessary
• Main responsible for authoring CMC dossiers and HAQs for US and ROW markets
• Accountable for identifying yield improvements initiatives and work with technical execution team to drive implementation
• Proactively conduct CPV and trend relevant process parameters in collaboration with automation and CPV SME in the MSAT Technical Standard team
• Authors CPV reports and protocols under the guidance of the Technical Standard team
• Accountable for annual Product reviews
• 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:

• Bachelors degree
• 7+ years industrial experience in Biopharmaceutical process development, MSAT or CMC roles
• CMC technical writing skills
• Understanding and experience with Process Validation principle, experience with commercial products Control Strategy
• Experience with complex regulatory submission and response with a variety of Regulatory Agency (FDA, EMA, JP, China etc.)

Preferred Qualifications:

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

• Strong understanding of bioprocessing principle for DS bioprocesses
• Demonstrate ability to work in a cross-functional, matrix environment and understanding of governance roles
• Deep knowledge and understanding of current trends in the industry, ICH Guidelines and FDA/EU validation practices for biopharmaceutical processes at commercial scale
• Ability to manage cross-functionally a variety of stakeholder
• Strong interpersonal and leadership skills. Committed team player prepared to work in and embrace a team-based culture.
• 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.
• Strong technical writing in CMC environment.
• Thorough understanding of bioprocesses for DS manufacturing
• Demonstrated experience with commercial manufacturing, NPI and commercial launches

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