About the position
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.
Responsibilities
- 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.
Requirements
- 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.
Nice-to-haves
- 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.
Benefits
- Health care and other insurance benefits (for employee and family).
- Retirement benefits.
- Paid holidays.
- Vacation.
- Paid caregiver/parental and medical leave.
