Biologics DP Leader

The Global Manufacturing Science and Technology (MSAT) organization is a network-focused function which provides strategic direction and technical / operational support to ensure that GSK Global Supply Chain (GSC) network, and site goals/objectives for life-saving medicines are achieved, through a focused strategy execution. As the Biologics Drug Product Leader, you will be responsible for technical leadership for injectable drug products (both biologic and oligonucleotide) spanning new product introduction (NPI) to post-approval commercial supply across multiple manufacturing sites as appropriate while maintaining key relationships with the operational teams on manufacturing sites, particularly MSAT, Production, Engineering and Quality and also with R&D. The Biologics Drug Product Lead is responsible for technology transfer, process validation, supports regulatory filing activities, preparation for PAI and technical support through the product lifecycle including knowledge management.,

• Be responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for drug product: Technical Risk Assessment, Product Control Strategy, Stage 2 and Stage 3 (PPQ and CPV) Process Validation, Process Robustness Assessment, leads cross functional improvement projects, and change implementation impact assessments on CQAs/CPPs. Ensures risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. CAPAs or governance boards
• Lead the technology transfer from R&D and between manufacturing sites, internally and externally while ensuring QbD principles are applied and a robust and well understood process and product control strategy are transferred during technical transfer, full scale development and commercialisation.
• Provide technical input to regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.
• Respond to technical questions during regulatory submission and inspections. Recommends Technical readiness to launch, including technical aspects of Transfer Acceptance Criteria are achieved.
• Be principal point of contact for all aspects of current and previous knowledge on the product and performance, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable for maintaining this knowledge and sharing as appropriate., We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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• BSc in Scientific Discipline (Scientific, Engineering, Technical)
• Experienced in late-stage process development or MSAT roles supporting industrialization & commercialization
• Experienced in technology transfer, with an understanding of the product development process, regulatory requirements for biopharmaceutical production.
• Excellent problem solver and ability to think and work creatively.
• Must have excellent verbal and written communication skills, and ability to influence, lead and drive change demonstrated through relevant work experiences.
• Broad and integrated knowledge and experience that can impact project and workgroup direction.
Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
• Post Graduate Degree (Scientific, Engineering, Technical)
• Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.
• Track record of improving products, processes and trouble-shooting, execution of technical activities including validation activities
• Demonstrated experience in the Pharmaceutical industry in leading the Technical aspects of Product Lifecycle Management.
• Demonstrated knowledge of Quality by Design and risk management approaches
• Demonstrated record of achievement and broad integrated knowledge of all aspects of biopharmaceutical production processes, and ability to work effectively in cross-functional teams to deliver results to agreed timelines.
  
  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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