Senior Scientist, Process Technology
Site Name: USA - Pennsylvania - King of Prussia Posted Date: Jul 6 2021 Are you a highly motivated scientist who is looking for a role where you can leverage your skills in large-scale manufacturing or biopharmaceutical process development? If so, this Senior Scientist - Process Technology role would be a great opportunity to consider. As a Senior Scientist - 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 Downstream Purification. 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: A degree in chemical engineering, biochemical sciences, or related engineering/scientific disciplines with a minimum two (2) years relevant experience. Experience with lab/pilot scale protein purification methods including chromatography, ultrafiltration, depth filtration, centrifugation and buffer preparation. Knowledgeable in cGMPs and regulatory requirements. Knowledgeable in technology transfer, process scale-up and manufacturing experience. Excellent troubleshooting/problem analysis skills. Experience with Lean Sigma and Root Cause Analysis methodologies highly desirable. Preferred Qualifications: If you have the following characteristics, it would be a plus: Excellent written and oral communications skills. Excellent 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? 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.