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Investigator – Device Analysis

As an Investigator in Drug Substance & Drug Product Analytical Development at GSK you will design and perform drug product and combination product testing, applying and integrating results from a range of analytical methods & advanced mechanical testing.
Organization: GlaxoSmithKline, LLC
Location: Pennsylvania
Contact: Susan Seward – susan.x.seward@gsk.com
Posted until: 5/22/2024
Employment type: Full time
Organization type: Industry

Full description:

Site Name: USA – Pennsylvania – Upper Providence

Posted Date: Feb 21 2024


Are you seeking an opportunity where you can help deliver life changing medicines and devices leveraging your expertise in an analytical environment? Do you have experience in mechanical testing, or combination device testing? Come join us and help unite science, technology, and talent to get ahead of disease together! At GSK we aim to positively impact the health of 2.5 billion people over the next 10 years.


Following successful candidacy, you will join a dynamic and growing team that will deliver critical device testing and data analysis, enabling the progression of combination products from early development to commercialization. This team will be closely integrated with parallel efforts across GSK in device-ability, drug formulation, and quality control.


As an Investigator in Drug Substance and Drug Product Analytical Development, you will design and perform drug product and combination product testing, applying and integrating results from a range of analytical methods and advanced mechanical testing equipment. This role is focused on delivering robust testing procedures and data assessments enabling the selection and refinement of the next generation of GSK injection device and drug combination products. You will play key role in ensuring that the best combination device solutions are provided to patients through your expertise in injection device analytics.


Your responsibilities include the following:

This role will provide YOU the opportunity to help develop, influence, and commercialize new medicines and combination products while progressing YOUR career.

  • Build and maintain expertise in automated combination injection device testing to help drive innovation and efficiency.
  • Perform GMP analytical laboratory experiments and technical analysis to support device and formulation selection and development. This includes analysis to support release or rejection of combination products.
  • Execute and/or supervise the execution of method validation experiments for autoinjector analytical methodologies in accordance to regulatory standards in line with Quality by Design (QbD) principals. 
  • Participate in cGMP analytical method transfers from R&D to commercial quality control laboratories for auto-injection device and combination product testing.
  • Independently write and edit sections for patents or regulatory submissions, authors scientific papers and internal reports
  • Document laboratory work in accordance with cGxP expectations, company policy, and legal requirements.
  • Review experiments, analytical methods, method validation protocols and reports, stability protocols, and other technical documents.
  • Performs data management tasks including recording results effectively in electronic laboratory notebooks or computer independently (e.g., tabulating and graphing results).
  • Provides input, and as appropriate, lead troubleshooting and problem-solving activities as they occur during the development process.
  • Interpret results and form conclusions to share with the project team and line management as appropriate.
  • Follows safety requirements for laboratory/working environment.


Why you?

Basic Qualifications:

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

  • BS in chemical engineering, biomedical engineering, mechanical engineering, physics or related scientific field with 7+ years of relevant experience, or MS in Chemistry, or related scientific field with 5+ years of relevant experience, or PhD with 1+ years of work experience or a PhD thesis focused on a related topic.
  • Experience working with several analytical techniques and laboratory procedures.
  • Experience with modern data analytic approaches and analytical data analysis.

Preferred Qualifications:

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

  • Detailed understanding of regulatory-recognized international consensus standards relevant to autoinjector and on body delivery device testing (e.g., ISO 11608) and related guidance documents.
  • Prior experience with cGMP GxP or GLP combination injection device analysis.
  • Extensive experience designing and executing mechanical testing of injector devices using manual, semi-automated or fully automated testing platforms.
  • Experience customizing fixtures and jigs for mechanical and/or device testing.
  • Proficiency in programing and automating mechanical testing routines for testing combination injection devices.
  • Familiarity with FDA/EU/UK and ICH regulations and guidance particularly related to Analytical Transfer and Validation, Critical Quality Attributes, and Release and Stability testing.
  • Experience with both small molecule and biopharmaceutical analytical development.
  • Strong technical writing skills for documentation.
  • Strong track record of multidisciplinary collaborations or experience working in matrix teams.
  • Experience applying data analytics and data visualization tools for promoting quality and consistency in analytical methods.
  • Experience with colloids and multiphase systems with an understanding of the interplay of physiochemical properties and rheology on combination device performance.
  • Collaborates well with others in the group and across groups.
Logo of company GlaxoSmithKline, LLC

GlaxoSmithKline, LLC

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