Description

Site Name: USA - Maryland - Rockville
Posted Date: May 30 2025

At GSK, Product Lifecycle Manager, within the Technical Standard site MSAT, is the primary accountable for creating and maintaining adequate Product Lifecycle Management (PLM) strategy for the commercial biopharmaceutical assets at Rockville site. The job aims at providing site expertise on PLM standards, especially around CPV, and ensure the strategy for PLM are adequate.

The role will work in a matrix environment and will be participating in Community of Practice/ Task Forces in collaboration with global functions. You will be accountable for maintaining appropriate validated lifecycle management strategies for product mostly in 3A and 3B of process validation stage and responsible for maintaining up to date with best practices and trends in the industry. This role is highly cross-functional and report into the site Technical Standard Lead while maintaining a dotted line into the global MSAT organization for Process Validation.

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

• Collaborate with product owners to establish and maintain adequate validation strategies and CPV approaches for products in the 3A and 3B stage of process validations
• Runs CPV meetings across products and track actions
• Works with automation and data science team in reviewing process parameters trends and establish robust processes for tracking and trending
• Proactively escalates and promotes discussion for any out of trends and work cross-functionally to propose solutions to trending challenges
• Acts as site SME for CPV and Process Validation and is main accountable person during inspections and audits
• Accountable for running CPV meetings across the different biopharmaceutical products from the Rockville site
• Review CPV procedures and SOPs
• Review and approved CPV report at the end of each campaign
• Stay current with industry best practice and regulatory/ compliance expectations on product lifecycle

Why you?

Basic Qualifications:

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

• Bachelors degree
• 10+ years of industrial experience in Biopharmaceutical process development, MSAT or CMC roles with emphasis on lifecycle approaches
• Experience with current trends in the industry, ICH Guidelines and GMP principles at commercial scale
• Prior experience with Process validation and continuous process verification is a must
• Understanding and experience within product lifecycle requirement at different stages of validation (3A vs 3B)
• Prior experience with NPI, commercial processes are required

Preferred Qualifications:

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

• Demonstrated knowledge and understanding of PPQ strategy for DS biologics manufacturing processes, continuous process verification and overall validation strategy
• Ability to partner with cross-functional partners in global organization are required
• Strong interpersonal and leadership skills. Committed team player prepared to work in and embrace a team-based culture.
• Able to interact well cross-functionally within the site and with multiple stakeholders out of the sites, in and out of GSC organization (GRA, global compliance etc.).
• Strong verbal and presentation communication skills which emphasize teamwork with a strong quality orientation.
• Strong capability to prioritize effectively and deploy resources to ensure prompt resolutions to day to day issues.

#LI-GSK

The annual base salary for new hires in this position ranges from $109,725 to $182,875 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

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).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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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.

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