As an Investigator, within Sterile Operations, you will be responsible for the site-based hands-on manufacturing of sterile clinical drug product.  You will also be accountable for batch preparation activities; including planning, forecasting and coordinating manufacture to meet agreed project timelines.  

You will be responsible for assisting in the development efforts required bringing the clinical supplies (product) into the UM pilot plant and technical transfer to GSK commercial sites.  You will also support due-diligence efforts and/or provide person-in-plant support at external contractor sites.

Key Responsibilities:

• Perform hands-on manufacturing of parenteral products, through leading batch activities in the pilot plant and pre-clinical manufacturing areas.
• Coordinate with project teams to understand the drug product manufacturing process and provide technical expertise to introduce the process into to the Sterile Manufacturing pilot plant in a compliant manner.
• Interface with manufacturing operations to ensure day to day activities are scheduled and managed appropriately.
• Strong understanding and application of aseptic manufacturing principles to implement new technologies / process to the Sterile pilot plant.
• Ensure compliance with cGMPs, SOPs, and GSK standards of documentation to support sterile manufacturing.
• Ensure that manufacturing processes remain compliant with all regulatory expectations and GSK policies and standards.
• Provide technical expertise in the sterile manufacturing environment, participate in audits of external manufacturing sites as needed.
• Oversee the preparation of GMP/GLP documents such as Standard Operating Procedures, Production Forms, batch records, Logbooks, and Laboratory Notebooks.
• Prepare and review master batch records, process documentation, and bulk production records as needed.
• Inspect work area for safety regulations and recommend improvements.
• Support external due diligence efforts and technical support for manufacturing at CMO sites as needed.

Why you?

Basic Qualifications:

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

• Master’s or Bachelor’s Degree in a scientific discipline with (2-3) years experience supporting sterile manufacturing / sterile formulation development

• Experience working / transferring processes to  a cGMP environment (2-5 years)
   

Preferred Qualifications:

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

• PhD in Chemistry, Microbiology, or Pharmaceutical Sciences or related field with 0-3 years experience in the manufacture / formulation development of sterile drug products
• Thorough knowledge of, and experience working with long acting injectables
• Experience in formulation / manufacture of lyophilized dosage forms. 
• Grade B gown qualification or willingness to seek qualification as part of role expectations. 
• Awareness of aseptic principles and sterility assurance in aseptic processing
• Ability to work in a complex, multi-tasking environment across local and functional boundaries.
• Ability to organize and effectively lead multiple diverse, cross-functional teams 
• Excellent oral and written communication skills; commitment to transparency; ability to build consensus and effectively negotiate resolution to complex technical and business issues
• Thorough knowledge of, and experience working with, cGMP’s and documentation principles for the manufacture of sterile drug products, or similar highly regulated environment

#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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