- Organization Type
Site Name: USA - Pennsylvania - Upper Providence Posted Date: Apr 27 2021 GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Biopharm Process Development is a highly experienced Chemistry, Manufacturing and Controls (CMC) organization accountable for delivering robust, cost effective and competitive products and manufacturing processes spanning the full life cycle of asset development from Discovery through commercialization. These activities are delivered through state-of-the-art internal facilities as well as strategic external partners. Collectively, the team is accountable for CMC activities encompassing cell line development, cell culture/ microbial fermentation, purification development, and drug product/ device development. We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience. The successful candidate will join a Product Development Team within the Biopharmaceutical Product Sciences (BPS) department of the Biopharm Product Development & Supply organization within GSK R&D, and will work on developing drug product formulation, manufacturing process and delivery systems for protein & peptide-based therapeutics. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Laboratory experimentation and analytical testing of putative formulations & drug product manufacturing Administration/delivery approaches for select protein therapeutic assets, which includes contributing to the conception & evaluation of conventional & novel product matrices and administration modalities Physicochemical and bioanalytical characterization of native and modified biopharm compounds Crafting & execution of non-GMP stability protocols to test quality & stability of product formulations Working closely with internal & external discovery and development support partners, as needed Maintaining accurate, complete laboratory records Facile use of electronic data & information gathering, capture, archiving and communications 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 0-3 years of protein formulation and drug delivery development experience; or, MS degree with 5-7 years of similar experience; or, BS degree with 10 or more years of similar experience. Experience in protein and peptide chemistry Experience with formulation and Biophysical Characterization of Biopharms Experience with biophysical techniques for product characterization and stability evaluation e.g., Spectroscopy (UV/VIS, fluorescence, or CD), Differential Scanning Calorimetry, UNcle, Prometheus, particles size evaluation (MFI, HIAC, Archimedes), light scattering, Isothermal Calorimetry. 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 (SEC, CEX), CGE, capillary electrophoresis, & cIEF, etc. Experience with both conventional and alternative biopharmaceutical protein formulation, and drug product development, including the application of DOE and other statistically-based experimental design/interpretation approaches. Experience with protein product manufacturing processes and development (e.g., solution (vial/PFS), or lyophilization; container/closure assessment & selection), drug delivery (e.g., combination product, device & administration kit) feasibility and compatibility evaluation. Experience in authoring, contributing to, and critical review of successful regulatory submissions; with particular emphasis on early 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 would be beneficial. 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. Able to demonstrate the ability to maintain accurate, complete laboratory records and facile use of electronic data & information gathering, capture, archiving and communications techniques. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. *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. 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.