Manufacture Planning Coordinator

The Manufacture Planning Coordinator is responsible for secondary manufacturing and testing for biopharmaceutical drug product, supporting safety assessment studies and clinical trials for early and late stage assets. The Manufacture Planning Coordinator will facilitate activities between process development, GMP Operations, and sterile filling sites.

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

• Coordinate planning for secondary manufacturing and testing for biopharmaceutical drug product as required supporting safety assessment studies and clinical trials for early and late stage assets.
• Coordinates activities between process development, GMP Operations, and sterile filling sites. Serves as supporting member to the project team.
• Executes planning and logistics for secondary manufacture, testing, shipments, storage, and release activities across internal/external sites. And has the ability to track product inventory in material management systems.
• Align to standard work across all aspects of operational planning (including customer service, order fulfilment and supply chain planning) within the planning team.
• Manage and support logistical shipping of material for domestic and international activities.
• Work in alignment with Biopharm Process Sciences, Analytical scientists, and manufacturing sites in oversight and implementation of appropriate technologies. Collect data, analyze results fully and recommend follow-up actions.
• Support process improvements to the supply chain cycle time.
• Ensure documentation is sufficient to support consistent production and regulatory filings.
• Prepares, reviews, and/or approves documents for use in manufacturing and planning. May also prepare campaign summaries and documents for validation and regulatory purposes.
• Coordinate Secondary Manufacturing operations planning for BPDS clinical supplies for the early and late stage assets in the portfolio. This role will support the process release of Tox, Reference Standard and Clinical material, completion of logistical/documentation aspects of shipping requirements.
• Support the BioPPD/MPD/Product Teams and the filling schedule of Biopharm operations across multiple filling locations (both domestic and international).
• Responsible for facilitating the manufacture planning meetings for the assets responsible for managing
• Accountable for reporting and maintaining metrics
• Initiate and own aspects of change management for revisions to specifications and filling sites as required.
  

Why you?

Basic Qualifications:

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

• BS in relevant field with 3+ years' experience in manufacturing operations
• 1 year knowledgeable in cGMP, especially documentation, process, and validation.
• 1 year of experience with Material Management Systems, Microsoft One Note, and Excel.
• 1 year experience in continuous improvement projects and/or activities.
• 1 year experience developing and presenting detailed planning and order fulfilment scenarios.
• 1 year experience using Lean Sigma and Root Cause Analysis methodologies for process improvement.
• 1 year experience assimilate information from different sources to foresee and proactively prevent issues.
• 1 year experience about material management techniques and planning processes.

Preferred Qualifications:

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

• Time management and prioritization skills.
• Attention to detail and ability to work under pressure.
• Excellent numeracy and communication skills both written and verbal, including basic presentation skills.
• Excellent organizational and teamwork skills
  

Why GSK?

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.

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.

#LI-GSK

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.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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