Biologics Dp Leader

**Site Name**: UK - County Durham - Barnard Castle, Italy - Parma
**Posted Date**: Dec 17 2024
**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.
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our webpage _Life at GSK | GSK_
**In this role you will**
- 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.
**_ Why you?_**
**Basic Qualifications & Skills**:
**We are looking for professionals with these required skills to achieve our goals**:
- 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.
**Closing Date for Applications - 17th January 2025 (COB)**
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