Investigator – Combination Injection Device Analyst

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Feb 1 2023 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, demonstrated technical expertise 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. Why GSK? 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 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.