Investigator, Process Technology

Are you looking for a challenging opportunity that allows you to leverage your technical expertise to accelerate delivery in biopharmaceuticals? If so, this Process Technology Investigator role could be an exciting opportunity to explore.

As a Process Technology Investigator you will be responsible for building and enhancing biopharmaceutical expertise to be further embedded in the business.

This role will provide you the opportunity to lead key activities to progress your career, these responsibilities include but not limited to the following…

• Responsible for process technology transfer from Bioprocess development groups (internal and/or external) to GMP Operations or third-party contract manufacturers.
  
• Conducts facility fit assessments and leads process introduction activities.
  
• Monitors technical operations of the process through communication with Manufacturing Scientists.
  
• Coordinates efforts to transfer technology forward to contract manufacturers and other partners.
  
• Coordinate activities and represents the Process Technology department at multi-disciplinary matrix teams.
  
• Successfully troubleshoots production problems for biopharmaceutical production campaigns within the Biopharm R&D portfolio.
  
• Leads quality investigations and continuous improvement projects.
  
• Ensures manufacturing campaign data and supporting information is sufficient to support regulatory packages and filings.
  
• Authors manufacturing and process sections of regulatory submissions and responses to regulatory questions.
  
• Develops and industrializes technologies essential to large scale or cGMP production.
  
• Responsible for authoring and approval of batch documentation.
  
• Oversees departmental administrative functions, such as raw materials management.
  
• Provides training and guidance to Manufacturing Scientists and less experienced personnel.
  
• Develops, evaluates, and supports introduction of technologies essential to large-scale cGMP production.
  
• International and domestic travel may be required (up to 50%).
  

Why you?

Basic Qualifications:

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

• Ph.D. in chemical engineering, biochemical sciences, or related engineering/scientific disciplines with a minimum two (2) years relevant experience, or M.S. in these disciplines with a minimum four (4) years relevant experience, or B.S. in these disciplines with a minimum of six (6) years of relevant experience.
  
• Proficient in cGMPs and regulatory requirements.
  
• Proficient in process technology transfer and process scale-up.
  
• Excellent troubleshooting/problem analysis skills. Experience with Lean Sigma and Root Cause Analysis methodologies highly desirable.
  

Preferred Qualifications:

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

• Experience with Lean Sigma and Root Cause Analysis methodologies highly desirable.
  
• Lab/pilot scale cell culture/fermentation operations which include, small scale seed scale up, bioreactor operations (single use knowledge desirable), alternating tangential flow filtration (ATF), depth filtration, centrifugation and media preparation.
  
• Lab/pilot scale protein purification methods, including chromatography, ultrafiltration/diafiltration, depth filtration, centrifugation and buffer preparation.
  

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  
• Continuously looking for opportunities to learn, build skills and share learning.
  
• Sustaining energy and well-being.
  
• Building strong relationships and collaboration, honest and open conversations.
  
• Budgeting and cost-consciousness.
  

#LI-GSK

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