Product Lifecycle Manager

Senior Process Validation & CPV Lead at GSK

This role offers you the opportunity to significantly advance your career by leading critical activities in process validation and continuous process verification (CPV) for biopharmaceutical products.

What You’ll Be Doing:

• Collaborate on Validation Strategies: Work with product owners to develop and maintain robust validation strategies and CPV approaches for products in the 3A and 3B stages of process validation.
• Lead CPV Meetings: Run CPV meetings across various products and meticulously track all actions.
• Trend Analysis & Process Improvement: Partner with automation and data science teams to review process parameter trends and establish robust processes for tracking and trending data.
• Proactive Escalation & Problem Solving: Proactively escalate any out-of-trend observations, facilitate discussions, and collaborate cross-functionally to propose solutions to trending challenges.
• Site Subject Matter Expert (SME): Act as the site SME for CPV and Process Validation, serving as the primary accountable person during inspections and audits.
• CPV Meeting Accountability: Be accountable for running CPV meetings for diverse biopharmaceutical products at the Rockville site.
• Documentation Review & Approval: Review CPV procedures and Standard Operating Procedures (SOPs), and review and approve CPV reports at the end of each campaign.
• Stay Current with Best Practices: Remain up-to-date with industry best practices and regulatory/compliance expectations regarding product lifecycle management.

Why You’re a Great Fit:

Basic Qualifications:

We’re looking for professionals with these essential skills:

• Bachelor’s degree.
• 10+ years of industrial experience in biopharmaceutical process development, Manufacturing Science and Technology (MSAT), or Chemistry, Manufacturing, and Controls (CMC) roles, with a strong emphasis on lifecycle approaches.
• Experience with current industry trends, ICH Guidelines, and Good Manufacturing Practice (GMP) principles at a commercial scale.
• Prior experience with Process Validation and Continuous Process Verification (CPV) is a must.
• Understanding and experience within product lifecycle requirements at different stages of validation (3A vs. 3B).
• Prior experience with New Product Introduction (NPI) and commercial processes is required.

Preferred Qualifications:

These characteristics would be a significant plus:

• Demonstrated knowledge and understanding of Process Performance Qualification (PPQ) strategy for Drug Substance (DS) biologics manufacturing processes, continuous process verification, and overall validation strategy.
• Ability to partner with cross-functional teams within a global organization.
• Strong interpersonal and leadership skills, and a commitment to working in and embracing a team-based culture.
• Ability to interact effectively cross-functionally within the site and with multiple external stakeholders (e.g., Global Regulatory Affairs, global compliance).
• Strong verbal and presentation communication skills that emphasize teamwork and a strong quality orientation.
• Strong capability to prioritize effectively and deploy resources to ensure prompt resolutions to day-to-day issues.

Compensation & Benefits:

The annual base salary for new hires in this position typically ranges from $109,725 to $182,875. This range considers factors such as work location within the US, the candidate’s skills, experience, education level, and the market rate for the role. In addition to base salary, this position offers an annual bonus and eligibility to participate in our share-based long-term incentive program, which varies based on the role’s level.

Our comprehensive benefits package includes:

• Health care and other insurance benefits (for employee and family).
• Retirement benefits.

Why GSK?

At GSK, we are a global biopharma company with a clear purpose: to unite science, technology, and talent to get ahead of disease together. Our ambition is to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns, all while being an organization where people can thrive. We focus on preventing and treating diseases through vaccines, specialty medicines, and general medicines. Our scientific focus is on the immune system, leveraging new platform and data technologies, with investments in four core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology.

Our success fundamentally depends on our people. “Getting ahead of disease together” is not just about our ambition for patients and shareholders; it’s also about making GSK a place where you can thrive. We want GSK to be a place where you feel inspired, encouraged, and challenged to be your best self. A place where you can truly be yourself—feeling welcome, valued, and included—where you can continue to grow and look after your well-being. If you share our ambition, join us at this exciting moment in our journey to Get Ahead Together.

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