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Principal Scientist/Investigator

Employer
GSK
Location
Collegeville, PA
Salary
Competitive
Closing date
May 25, 2022

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Site Name: USA - Pennsylvania - Upper Providence Posted Date: May 20 2022 Are you energized by the challenge of developing new drug products for our patients? If so, this Principal Scientist/ Investigator role will provide you an opportunity to work toward your goal. As a Principal Scientist/ Investigator you will be responsible for developing biopharm drug product formulation, manufacturing process and delivery systems for protein & peptide-based therapeutics, and playing an important role to bring product from clinical development phase to commercialization. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following Physicochemical and bioanalytical characterization of native and modified biopharm compounds Authoring & execution of non-GMP stability protocols to test quality & stability of product formulations Developing manufacturing processes, scale-up and tech transfer to manufacturing sites. Author and review technical protocols and reports in support of projects in various stages of development. 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 communication 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 degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline with 0+ years of protein formulation and drug delivery development experience; or, MS degree with 5+ years of similar experience; or, BS degree with 10+ years of similar experience. One year experience of protein and peptide chemistry; and Formulation and Biophysical Characterization of Biopharms One year experience with biophysical techniques for product characterization Experience in authoring technical reports and documentation (IND/IMPD, BLA/MAA, etc.) 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, Spectroscopy (UV/VIS, fluorescence, or CD), Differential Scanning Calorimetry, UNit/ UNcle, Prometheus, particles size evaluation (MFI, FlowCam, Archimedes), light scattering, Isothermal Calorimetry, etc. Creative and motivated self-starter with excellent verbal and written communication skills Experience with both conventional and alternative biopharmaceutical protein formulation, and drug product development and stability evaluation, including the application of DOE and other statistically based experimental design/interpretation approaches. Experience with protein product manufacturing processes and development (e.g., solution in vial/PFS, or lyophilization); container/closure assessment & selection, drug delivery (e.g., combination product, device & administration kit) feasibility and compatibility evaluation. Experience in authoring regulatory documentation (IND/IMPD, BLA/MAA, etc.); 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, with excellent verbal and written communication skills, demonstrated ability to work independently and ability to work effectively in team and matrix environments. Demonstrated ability to maintain accurate, complete laboratory records and facile use of electronic data & information gathering, capture, archiving and communications techniques. Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest 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 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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