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Senior Scientist - Process Technology

King of Prussia, PA
Closing date
May 24, 2022

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Physical Sciences, Chemistry, Other, Manufacturing/QA/QC
Job Type
Senior 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 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 As a Senior Scientist, Upstream Process Technology, you will be responsible for building and enhancing biopharmaceutical expertise to be further embedded in the business. These include: Responsible for process technology transfer from Bioprocess development groups to GMP Operations. Conducts facility fit assessments and leads process introduction activities for downstream unit operations. Monitors technical operations of the process through communication with Manufacturing Scientists. Coordinates activities between Development groups. Represents the Process Technology department at multi-disciplinary matrix teams. Presents results/conclusions at these meetings. Responsible for successfully troubleshooting production problems and for the technical success of multi-million dollar biopharmaceutical production campaigns that support progression of the Biopharm R&D portfolio. Participates in quality investigations and continuous improvement projects. Responsible for ensuring that manufacturing campaign data and supporting information is sufficient to support regulatory packages and filings. Authors manufacturing and process sections of regulatory submissions and responses to regulatory questions. Responsible for authoring and approval of batch documentation. Conducts batch planning activities, such as raw materials management and/or water runs. Provides training and guidance to Manufacturing Scientists and less experienced personnel. Develops, evaluates, and supports industrialization and introduction of technologies essential to large-scale cGMP production. Highly visible position with above average level of accountability. Failure of a large-scale cell culture/fermentation or purification processes has ramifications throughout the research, development, and clinical organizations. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Monitors processes in Upstream Cell Culture. Collects information and prepares/maintains a campaign summary database of process knowledge, to be leveraged as assets progress in the biopharmaceutical development cycle. Analyzes results fully and recommends follow-up actions. Leads troubleshooting activities. Experience in bioprocessing, with a preferred background in downstream processing disciplines. Experience in biopharmaceutical process development, technology transfer, scale-up, and cGMP batch execution/troubleshooting. Knowledgeable in all aspects and unit operations that comprise the bioprocess and biomanufacturing downstream platform. Ensures that processes being transferred and supporting documentation are sufficient to support consistent production and regulatory filings. Conducts facility fit analysis and coordinates process introduction activities. Prepares and/or approves documents for use in technology transfer and manufacturing. Authors documents for regulatory purposes. Progresses the industrialization of technology essential to large scale cGMP production. Solves process and equipment problems. Recommends equipment and procedures. Keeps aware of new technology developments. Technically expert in purification technologies and unit operations. Coordinates activities between various Biopharmaceutical Development and Supply groups (i.e. project teams, formulations, quality, analytical, development, validation, engineering, etc.). Represents the Process Technology department in project teams and other multi-disciplinary matrix teams. Presents results/conclusions and contributes to the decision-making process within these teams. Provides support for technology transfer into Manufacturing Operations. Prepares and approves GMP documentation including master batch records. May play a leadership role for specific cGMP compliance/readiness projects (i.e., coordination of process scheduling, facility/equipment changeover). Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: M.S. in chemical engineering, biochemical sciences, or related engineering/scientific disciplines with 2+ years industrial experience B.S. in above disciplines with 4+ years of industrial experience. Experience with lab/pilot scale cell culture/fermentation operations which include, small scale seed scale up, bioreactor operations (single use knowledge desirable), alternating tangential flow filtration (ATF), depth filtration, centrifugation and media preparation. Experience working in a cGMPs environment and with regulatory requirements. Experience with technology transfer, process scale-up and manufacturing experience. Experience with Lean Sigma and/or Root Cause Analysis methodologies. Preferred Qualifications: If you have the following characteristics, it would be a plus: Excellent troubleshooting/problem analysis skills. Experience with Lean Good written and oral communications skills. Good organizational, collaboration, and teamwork skills. Strong interpersonal and leadership skills. Solid team player able to function within collaborative- and team-based organization. Experience in project management and delivery, including ability to prioritize and forward plan courses of action. Works independently with minimal to no direct supervision. 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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