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Reference #: 403304 Site Name: Upper Merion Posted Date: Aug 26 2024

Job Purpose:

This role is accountable for all manufacturing activities at Upper Merion Biopharm.

Key Responsibilities:

Responsible for the management of clinical / commercial drug substance manufacturing to meet all quality standards for GSK, FDA and any other regulatory agency which applies.

Responsible for the production of multiple products across various production biotechnology platforms operating on a 24hour/7day basis.

Recruit and develop a world class manufacturing organization

Responsible for assuring full compliance against all appropriate manufacturing regulations such as local policy and procedures, GSK QMS and CFR/cGMP.

Responsible for all operations, to ensure personnel, product and equipment safety.  Maintain compliant operations against all required GSK EHS/OSHA standards and all applicable environmental regulations (local, state, and federal).

Partner with the new product introduction (NPI) lead for successful implementation of new products and processes into the facility production equipment and schedules.

Establish production standards and resource requirements to meet delivery schedules.

Direct the evaluation and implementation of Continuous Improvement and Operational Excellence methods and tools to improve the overall efficiencies of production and reduce costs.

Drive cost of good reductions across product portfolio.

Serve as member of Site Leadership team to drive overall site strategy and culture

Why you?

Basic Qualifications:

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

BS/BA in either biological, chemical science, engineering or equivalent technical discipline. Biotechnology, Biochemical Engineering, Chemical or Mechanical Engineering strongly preferred.

10+ years of experience in biopharmaceutical industry with an emphasis in the commercialization and manufacture of biologics.  5+ years of large-scale cell culture or fermentation-based processing preferred as well.

Experience leading large teams.

Experience interfacing with regulatory agencies.

Preferred Qualifications:

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

MS or Ph.D. in biological science or biochemical engineering desirable.  Biotechnology, Biochemical Engineering strongly preferred.

Strong quality/compliance orientation and track record.

Excellent communication skills with all levels of the organization.

Strong influence and relationship building skills with an emphasis on teamwork.

Strong understanding of Industry 4.0 elements and maximizing the use of data

Strong understanding of lean six sigma / operational excellence principles

#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 fter 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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