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Biopharmaceutical Stability Lead

Employer
GSK
Location
King of Prussia, Pennsylvania
Salary
Competitive
Closing date
Oct 1, 2022

View more

Discipline
Life Sciences, Biochemistry
Organization Type
Pharma
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Are you interested in contributing your detailed analytical knowledge of biopharmaceuticals while designing and managing stability programs for biopharmaceutical projects in various phases of development ranging from Pre-Candidate Selection to Commercialization? If so, this Biopharmaceutical Stability Lead could be an ideal opportunity to explore.

As a Biopharmaceutical Stability Lead, you will gain experience in authoring relevant CMC sections of regulatory submissions and have an understanding of statistical analysis as it pertains to stability data trending and product shelf-life applications.

This role will provide you the opportunity to participate in key activities to progress your career. These responsibilities include some of the following :

  • Assist in the design of biopharmaceutical stability strategies and implementation of stability work processes in-line with regulatory and business requirements
  • Work with external contract organizations with respect to stability testing and data reporting
  • Author and review stability protocols and reports
  • Prepare analytical related content for relevant CMC sections of regulatory submissions
  • Become a stability subject matter expert for biopharmaceutical products
  • Participate in cross functional task forces when required to resolve specific technical issues


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • BS/MS with 2+ years of experience in biotechnology or pharmaceutical industry
  • Biopharmaceutical development experience with a focus on formulation development, analytical method development, and release and stability testing
  • Experience with managing project matrix teams and cross-functional task forces


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Theoretical understanding of the analytical techniques currently used to release and characterize proteins and/or oligosaccharides
  • Highly motivated and instinctive team player with excellent communication skills, both written and verbal
  • GMP experience
  • Deep understanding of ICH guidelines and compendial requirements
  • Hands-on experience in various protein separation, biological assays, and other characterization techniques such as CGE, cIEF, HPLC/UPLC, mass spectrometry, and functional assays
  • Highly motivated and instinctive team player with excellent organizational, communication skills, both written and verbal


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. 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

#CMCDevelopmentGSK

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