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Collegeville, PA
Closing date
Dec 10, 2021

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Physical Sciences, Chemistry
Job Type
Staff Scientist
Organization Type
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We are building a state-of-the-art end to end Biopharm capability which delivers efficient discovery of antibody 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 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. Within Biopharm Process Development, the Biopharm Product Sciences organization focuses on developing world class patient-centric biopharmaceutical drug products through innovation, technology and strategic partnering. The successful candidate will work on developing drug product and delivery systems for protein and peptide-based therapeutics. This role will include protein formulation and drug product process development activities. Role responsibilities will be focused around laboratory experimentation, analytical testing, and drug product manufacturing of putative formulations & drug delivery approaches for select protein therapeutic assets, which include contributing to the conception & evaluation of conventional & novel product matrices and administration modalities; physicochemical and bioanalytical characterization of Biopharm compounds; working with the CMC analytical group to define analytical method target profile for monitoring quality attributes for use in product development, release and stability testing; crafting & execution of non-GMP stability studies to generate product and drug product manufacturing process knowledge, and interfacing with the quality organization to craft GMP stability protocols and assess resultant data; 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; and, will also require authoring and review of SOPs, technical reports, and regulatory documentation (e.g., IND/IMPD, BLA/MAA/JNDA, etc.). This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Designs and executes protocols related to area of expertise Executes a wide range of experiments and development studies independently based on a protocol Identifies and troubleshoots problems in the execution of experimental processes, technical studies, and tasks. Fully understands the rationale and hypotheses for experimental designs and/or has extensive theoretical understanding of a particular area of science. Develops understanding of regulatory requirements Comply with data integrity requirements Authoring of technical reports and sections of regulatory documentation Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's with 4+ years of lab based experience or Master's degree with 2+ years of experience in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline Knowledge about competencies in protein or peptide chemistry, formulation and drug delivery/device development, and drug product manufacturing Experience maintaining accurate, complete laboratory records Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience with both conventional and alternative protein formulation and drug delivery/device approaches or experience in protein drug product manufacturing process (fill-finish) area. Experience using bioanalytical and/or biophysical techniques for critically assessing product characterization and product stability evaluation, including e.g., HPLC, capillary electrophoresis, SEC, Spectroscopy (UV/VIS, fluorescence, or CD), & DSC. Regulatory documentation authoring experience (IND/IMPD, BLA/MAA, etc.). Ability to work effectively in team and matrix environment Excellent verbal communication and technical writing skills Creative and motivated self-starter Strong organizational skills 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. 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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