Job description

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 device testing, or combination device testing for injectables? 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 and you will be a key resource for integrating data between diverse physical and chemical methods informing decision making. 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.

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

• Progress and lead analytical aspects of projects using injection device testing experience and expertise as part of a CMC Analytical team and wider matrix teams.
• 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 execution of method validation experiments for autoinjector analytical methodologies appropriate to clinical development phases and 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 GxP 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.
• Provides scientific and technical input and recommendations to inform the project team for decision making.
• 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 chemistry, physics, chemical engineering, biomedical engineering, mechanical engineering, or related scientific field with 7+ years of experience
• MS in Chemistry, or related scientific field with 5+ years of experience
• PhD with 1+ years of experience.
• Experience in working as an analytical scientist supporting device or combination product development and working in a matrix team environment. Including, but not limited to, method development, validation or transfer and regulatory filings.
• Experience and familiarity working with several analytical techniques and laboratory procedures.
• Experience with automation and/or testing platforms to analyze injection devices and/or combination products.
• Experience analyzing and interpreting experimental data.

Preferred Qualifications:

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

• Thorough operational knowledge of laboratory equipment.
• Awareness or demonstrated utility of modern data analytic approaches analytical data analysis.
• 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.
• 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.
• Thorough knowledge of cGMP requirements
• 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.

Job Type: Full-time

Salary: Up to $134,527.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance

Schedule:

• 8 hour shift

Supplemental pay types:

• Signing bonus

Ability to commute/relocate:

• Collegeville, PA 19426: Reliably commute or planning to relocate before starting work (Required)

Experience:

• analytical scientist: 3 years (Preferred)

Work Location: Hybrid remote in Collegeville, PA 19426

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