The Senior Scientist, Sterile Manufacturing Operations accountable for the sterile manufacture of clinical and pre-clinical sterile drug product, including planning, co-ordination, and manufacturing operations.  Ensures all activities are conducted in full compliance with cGMP’s, safety regulations, and critical business requirements. Develop into Technical subject matter expert for clinical operation activities as they relate to the UM Sterile Pilot Plant.

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

• Independently coordinate the daily activities of the area supporting the manufacture of early phase injectable products to support pre-clinical and clinical needs.
• Ensure products manufactured are of the highest attainable level of quality and right first time.
• Engage with Product Teams to resolve product development issues related to aseptic processing technology or sterile manufacturing equipment.
• Ensure all production activities are performed following applicable cGMP’s and GSK procedures
• Ensure compliance with cGMPs, SOPs, and GSK standards of documentation to support sterile manufacturing.
• Ensure that the manufacturing process remains compliant with all applicable regulations.
• Provide expertise in the sterile manufacturing environment. Oversee the preparation of GMP/GLP documents such as Standard Operating Procedures, Production Forms, Logbooks, and Laboratory Notebooks.
• Write, review, and approve SOP’s and other technical documents for process equipment, facilities, and manufacturing processes
• Assist in the technology transfer of processes to GSC and CMO sites; provide technical support for the development and introduction of novel manufacturing technologies.
• May support third party manufacturing activities as a “person in plant”

Why you?

Basic Qualifications:

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

• Bachelor’s Degree in Microbiology / Biology/ Engineering or similar science field
• 1+ year experience working with cGMP’s and documentation principles for the manufacture of drug product in a highly regulated environment.
• Experience working with aseptic techniques and sterility assurance in aseptic processing

Preferred Qualifications:

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

• 2+ years’ experience working in a GMP drug product manufacturing environment is desired.
• Ability to work in a complex, multi-tasking environment across local and functional boundaries
• Knowledge of pharmaceutical pilot plant technical operations
• Excellent oral and written communication skills

#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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