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Biopharmaceutical Drug Product Investigator

Employer
GSK
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
Sep 30, 2022

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Discipline
Life Sciences, Biochemistry
Job Type
Group Leader/Principal Investigator
Organization Type
Pharma
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We are building a state-of-the-art end to end Biopharm capability which delivers efficient discovery of antibody molecules that are selected and engineered for rapid development so that, together with our therapy area partners, we discover, develop and manufacture novel portfolio of exciting medicines to benefit patients around the world. If you aim to be part of a global cutting edge drug development and discovery organization and are motivated to contribute towards bringing lifesaving drugs to patients , join us!

Click here to know more about GSK Biopharm.

#GSKBiopharm_Development

Are you looking for a collaborative Investigator role that allows you to contribute to scientific strategy and accelerate Pharmaceutical Research and Development? If so, this role could be an ideal opportunity to explore.

As a Biopharmaceutical Drug Product Investigator, you will join a Product Development Team within the Steriles Drug Product Development (DPD) department of the Medicine Development & Supply organization within GSK R&D, and will work on developing drug product formulation, manufacturing process and delivery systems for protein & peptide-based therapeutics.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
  • Developing manufacturing processes, scaling them up and transferring them to manufacturing organizations.
  • Laboratory experimentation and analytical testing of putative formulations & drug product manufacturing and administration/delivery approaches for select protein therapeutic assets, which includes contributing to the conception & evaluation of conventional & novel product matrices and administration modalities
  • Physicochemical and bioanalytical characterization of native and modified biopharm compounds
  • Crafting & execution of non-GMP stability protocols to test quality & stability of product formulations
  • Working closely with internal & external development support partners, as needed
  • Maintaining accurate, complete laboratory records
  • Facile use of electronic data & information gathering, capture, archiving and communications techniques
  • Assisting in preparation and review of SOPs, and regulatory documentation, as appropriate


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • PhD OR Master's degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, OR Bachelor's degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, with least 1 years of relevant experience of​protein and peptide chemistry; and Formulation and Biophysical Characterization of Biopharms
  • 1 year experience with biophysical techniques for product characterization and stability evaluation including, e.g., Spectroscopy (UV/VIS, fluorescence, or CD), Differential Scanning Calorimetry, UNit/ UNcle, Prometheus, particles size evaluation (MFI, FlowCam, Archimedes), light scattering, Isothermal Calorimetry.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Experience and understanding of multiple bioanalytical techniques for product characterization and product stability evaluation, including HPLC, SDS-PAGE/CGE, SEC, capillary electrophoresis & chip-based methods, etc.
  • Experience with both conventional and alternative biopharmaceutical protein formulation, and drug product development, including the application of DOE and other statistically-based experimental design/interpretation approaches.
  • Experience with protein product manufacturing processes and development (e.g., solution (vial/PFS), or lyophilization; container/closure assessment & selection), drug delivery (e.g., combination product, device & administration kit) feasibility and compatibility evaluation.
  • Experience in authoring, contributing to, and critical review of successful regulatory submissions; with particular emphasis on late clinical phase submissions, and response to regulatory questions.
  • Experience in working with in vivo/ in vitro models to critically assess formulation & delivery modalities.
  • Experience in drug product manufacturing technology transfer to commercial and/or scale-up of clinical drug product manufacturing capabilities would be beneficial.
  • Creative and motivated self-starter,
  • Ability to collaborate well with others in and across groups.
  • Ability to maintain accurate, complete laboratory records and facile use of electronic data & information gathering, capture, archiving and communications techniques.

Why GSK?

Uniting science, talent, and technology to get ahead of disease together

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.​



With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.​



Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership ofgoals and support to succeed; and where we do the right thing . So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.​

GSKBiopharm_Development

*LI-GSK

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