Site Name: UK - County Durham - Barnard Castle, Upper Merion, Ware
Posted Date: Feb 8 2023
The Global Manufacturing Science and Technology (MSAT) organization is a network-focused function which provides strategic direction and technical and operational support to ensure that GSK Global Supply Chain (GSC) network and site goals and objectives are achieved, and determined strategy executed. Under CMC operating model, by partnering with R&D, operations, and supply chain, MSAT owns the end-end molecule development and commercialization. MSAT’s primary functions are to lead technology transfers, implement control strategies, provide technical process support across the product lifecycle, while implementing new products and new modalities for commercial products and product-related programs within the GSK GSC perimeter. MSAT is the keeper of the body of manufacturing process knowledge, creates the instruction set and ensures manufacturing operations stay aligned with the registered process.
A high calibre Industry expert in Primary Packaging to develop and commercialize packaging containers for our rich portfolio of Parenteral, Oral Solid Dosage (OSD) and Inhalation products. A technical leader to lead integration of primary containers in medical devices, shipping validation of bulk drug substance (BDS) in single use systems and lead companywide sustainability program on Primary Packaging. A true leader who will influence internally and externally, using effective communication skills to build partnerships at all levels of the business. You will need strong people and project leadership skills and must be comfortable working globally.
The candidate should have established track record of developing and commercializing primary containers used in medical devices. An in-depth understanding is essential in primary container selection, development, container-device design controls, risk management and Medical Device regulations. As the Primary Container Head, you will be responsible for primary container onboarding strategies across the whole GSK GSC product portfolio, delivering continuous improvement and lifecycle management of parenteral, OSD and Inhalation products. You will define these standards, ensuring capability across the business and our external supply partners through collaboration across GSC and R&D, covering both biopharma and small molecules.
Key Responsibilities include, but are not limited to:
Ownership of GSK primary container platforms both legacy and under development, Bulk Drug Substance (BDS) shipping validation and sustainability programs.
Lead characterization of containers such as Leachables & Extractables, assembly of primary containers into devices etc.
Management of external supply and project-specific change controls to ensure process capability and Essential Performance Requirements of commercial products.
New and legacy product site-to-site transfers; capacity upgrades, both at internal GSK sites and external partners.
Drive resolution of deviations and investigations for commercial products.
Represent commercial and manufacturing network perspective on primary container development working teams during the technology selection, development, characterization, and commercialization.
Drive technical teams by leveraging skill across network in solving complex problems using engineering modelling and simulation tools, design and prototyping tools, statistical analysis, benchtop experiments and analysis, design for manufacturability/assembly techniques and design for Six Sigma.
Ensuring effective and efficient, fit for purpose capability and processes are in place to support the industrialization of new platforms, continuous improvement of our existing platforms, adoption of new technologies and platform lifecycle management in conjunction with our 3rd party supply base partners.
Demonstrate a working understanding of regulatory, risk management, new technologies/trends, and design control related fields (21 CFR Part 820, ISO13485, ISO14971, and other relevant global standards).
Providing regulatory filing support (IND, BLA, MAA, etc.) for lifecycle management and building retrospective technical files for legacy and pipeline container-device products across the GSK portfolio.
Working with Global and Regional / Local Regulatory to understand, translate and apply appropriate regulations, being conversant with statutory obligations and GSK procedures for all regulatory requirements in devices.
Serve as a primary point of contact representing the organization with external agencies, partners, and vendors.
Identify, recruit, and retain talent to accomplish project and departmental objectives within agreed timelines, planning, maintaining, and managing departmental budgets, participate in capital planning and capital project execution.
Maintaining an active technical talent management and succession program for your team.
Leading and supporting the modernization of strategic innovation programs and franchise priority projects, working seamlessly with R&D and GSC organizations.
Partnering with R&D to define first intent platforms that support acceleration and intensification across the portfolio of parenteral devices.
Bachelor's degree (equivalent) in Engineering or science related fields.
10+ years of experience in development and commercialization of primary sterile container’s such as vials, syringes, cartridges, bottles, blisters, and shipping validation of bulk drug substance in single use systems in operations technical roles.
8+ years of experience in leading/managing multifaceted organizations.
If you have the following characteristics, it would be a plus:
Advanced degree MS or PhD.
Knowledge of multiple drug product dosage forms, container types, single use systems and medical devices.
Working knowledge of environment sustainability such as reduction of carbon footprint and understanding of environmentally friendly materials.
Conversant with GMP, Container-Medical device US/EU/ROW Regulations.
Track record of success in a management or leadership role.
Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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