Technology Manager- Secondment

As a technology manager, you will be responsible for managing certain elements (such as upstream or downstream) of the transfer of drug substance biopharmaceutical production technologies from donors (R&D, third party clients or contract manufacturing organizations) to the Upper Merion site; or from the Upper Merion site to other biopharmaceutical manufacturing sites. The tech manager will support the delivery of new biopharmaceutical applications and technologies, design and execute technical studies and protocols to confirm scale-up and successful technology transfer, analyze data and compile summary reports to make recommendations and successfully deliver process validation, deliver improvements to the existing supply chains supported by Upper Merion and the wider organization. This role supports efforts to continuously reduce product cost of goods and improve overall productivity while ensuring highly capable process control and product quality specifications are met for products supplied by the Upper Merion site..

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

• Support the introduction and scale-up of primary manufacturing processes (drug substance) transferred from R&D or third party clients for specific products to the Upper Merion site.
• Provide subject matter expertise and oversight and demonstrate accountability to support commercial manufacturing or technology transfer
• Manage the relationships between cross functional stakeholders and the Upper Merion site for specific assets and communicate and influence stakeholders as required.
• Propose strategies and priorities in planning technical transfer and process validation activities within areas of expertise.
• Responsible for process trend monitoring, analyses and assurance that key process parameters and attributes remain within control limits.
• Responsible for investigating and resolving process issues in a manner and timeframe consistent with production and quality goals for specific products.
• Provide technical training to production staff for new equipment and process technologies as required.
• Evaluate new technologies for GSK and define technology introduction strategies. Define long-term and short-term process improvements within area of expertise.
• Ensure technical accuracy of process documentation and related documentation for specific products. Responsible for ensuring that new technologies are properly validated at the Upper Merion site and that regulatory documents to support licensing of specific products are prepared.
• May need to contribute technical oversight of manufacturing operations and prepare / coordinate technical studies for various manufacturing stages at the Upper Merion site.
• Contribute to the evaluation and feasibility/facility fit of prospective new products and technologies into the Upper Merion site (e.g. site impact assessments, or review of requests for proposal)
• Demonstrate the use of production system / performance management (Lean Six Sigma) tools and philosophies to prioritize deliverables and solve problems.
• Provide real-time and in-person process monitoring and technical oversight for a 24-7 manufacturing facility which will require off hours and weekend support as needed.

Why you?

Basic Qualifications:

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

• Bachelor's degree in scientific discipline
• 3+ years post-graduate industrial experience in technology/biopharmaceutical process development, technical project management and process transfer to production in a manufacturing environment
• 2+ years supporting drug substance manufacturing
• 2+ years of downstream/purification

Preferred Qualifications:

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

• Upstream Experience with large scale cell culture, cell banking, seed scale-up, production bioreactor, single use systems, engineering protocols, regulatory submissions, Delta V, MES, IP21
• Downstream Experience with bioseparations, purification technologies, or pharmaceutical manufacturing of biologics and large molecules. Understanding of analytical technologies related to the above.
• Experience with NIH Guidelines and FDA and/or European validation practices for biopharmaceutical processes
• Strong interpersonal and matrix leadership skills.
• Strong verbal and written communication skills.
• Strong analytical and critical thinking skills.
• Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines.
• Able to provide leadership to generate options to resolve problems, prioritize, and decide appropriate courses of action. Effective at implementing decisions.
• Committed team player prepared to work within and embrace a team-based culture.
• Demonstrated leadership experience or potential.

#LI-GSK

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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