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Principal Scientist/Investigator- Early Engagement and Deviceability

Employer
GSK
Location
Collegeville, PA
Salary
Competitive
Closing date
May 15, 2022

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We are building a state-of-the-art end to end Biopharm capability which delivers efficient discovery of antibody and small 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 to know more about GSK Biopharm. #GSKBiopharm_Development GSK's Packaging and Device Design and Development team is charged with the delivery of robust, patient-centric devices and primary packaging solutions to enable the effective delivery of novel pharmaceuticals across all modalities and routes of administration. Our group is a multi-skilled team of Engineers and Scientists who work across all stages of the product and process development lifecycle, from the discovery interface through concept design and selection and, ultimately, the registrational submission and commercial supply. This position is being created to establish within GSK the capability to integrate technical attributes, patient and customer needs, business requirements, competitive landscape and technologies for drug-device combination (DDC) products. We are looking for an enthusiastic development engineer or scientist to support deviceability efforts to improve probability of technical success of development programs through early evaluation and design of suitable molecules, formulations and devices for our increasingly complex DDC products. You will join a dynamic and growing team that are key to delivering an expanding portfolio. The role is to be based at GSK's R&D site in Upper Providence, Pennsylvania (US) and can offer flexible hybrid working. Occasional travel may also be required. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Collaborate with internal teams within Discovery, Clinical, Commercial, Regulatory and Drug Product Development to develop on-target, patient-centric DDC products through early engagement. Develop new practices to ensure sufficient early characterization of molecule attributes is done to ensure compatibility with device requirements and that information available from early assessment is fed into device concept development and technology scouting. Integrate the deviceability framework into the design and selection of molecule, formulation, primary packaging, device, and delivery for the benefit of the patient injection experience and improved probability of technical success. Apply principles of product design and knowledge of patient needs to Quality Target Product Profiles (QTPP) to create a robust DDC product strategy and identify early CMC critical path activities. Incorporate internal and external best practices and lessons learned from DDC products challenges into deviceability strategy. Monitor industry trends, collaborate with academic and professional consortiums associated with deviceability. Work closely with internal device innovation group and recommend opportunities for technology exploration and investment based on company priorities, portfolio requirements and competitive insights. Adapt deviceability concepts as needed across modalities to properly inform discovery / development teams and design in the appropriate molecules and technology attributes. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD in Biomedical Engineering, Chemical Engineering, Pharmaceutics, Biology, Chemistry, or related scientific discipline with 0+ years of protein or small molecules formulation, DDC products or drug delivery development experience. Master's degree in related scientific discipline with 5+ years of similar experience listed above. Bachelor's degree in related scientific discipline with 10+ years of similar experience listed above. Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience in DDC products for large and small molecules including long acting injectables, liposomes, pre-filled syringes, autoinjectors, and on-body injectors. Experience with high-throughput measurements of concentration/viscosity profile, diffusion interaction parameter, sedimentation parameter, second virial coefficient. Experience with high-throughput screening of sensitivity to silicone oil and interfacial interactions. Experience with relevant in-silico modeling. Working experience of managing multiple projects of varying complexity simultaneously. Creative and motivated self-starter, with excellent verbal and written communication skills, demonstrated ability to work independently and the ability to work effectively in team and matrix environments. Strong time management / organisational skills Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes 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 genetics science; 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 disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as 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 culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals 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 this exciting moment in our journey. Join our challenge to get Ahead Together. *LI-GSK GSKBiopharm_Development 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.

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