Senior Scientist, Process Technology

GSK Site Location: Upper Merion - King of Prussia, PA. On-site presence of 2-3 days per week on average required.

Role Responsibilities:

• Prepares and/or approves documents for use in technology transfer and manufacturing including CGMP master batch records. Prepares and/or reviews documents for the regulatory submission and leads response to questions when appropriate. Ensures that the development and documentation are sufficient to support consistent production and regulatory filings.

• Monitors processes providing on the floor support and troubleshooting during manufacture. 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. Key participant in troubleshooting activities.

• Aids in the development of technology essential to large scale cGMP production. Solves process and equipment problems. Recommends equipment and procedures. Maintains awareness of new technology developments. Technically knowledgeable in areas of cell culture/fermentation.

• Coordinates activities between various Biopharmaceutical Development and Supply groups. Represents the department in projects specific CMC teams and other multi-disciplinary teams. Presents results/conclusions and contributes to the decision-making process within these teams.

• Provides support for technology transfer from CMO into GMP Operations. May provide oversight of manufacturing activities at CMO. Some international and domestic travel may be required (up to 50%). May support technology transfer into GSC facilities.

• Prepares and may approve SOPs in areas of expertise.

• May play a leadership role in specific cGMP compliance/readiness projects (i.e. Coordination of process scheduling, facility/equipment changeover, etc.0

• May lead or support Quality investigations or other Quality deliverables as appropriate.

Duties of the position:

• Responsible for process technology transfer from Bioprocess development groups (internal and/or external) to the UME B38 Pilot Plant or contract manufacturing organizations. Monitors technical operations of the process through communication with Manufacturing Scientists. Coordinates efforts to transfer technology forward to contract manufacturers and other partners.

• Coordinates activities between Development and Manufacturing 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.

• Responsible for ensuring the manufacturing campaign data and supporting information is sufficient to support regulatory packages and filings.

• Aids in implementing technologies essential to large scale or cGMP production.

• Responsible for authoring and approval of batch documentation.

• Provides training and guidance for less experienced personnel.

• Develops, evaluates, and supports introduction of technologies essential to large-scale cGMP production.

• Highly visible position with average level of accountability. Responsible for successful troubleshooting of production problems and for the technical success of multi-million dollar biopharmaceutical production campaigns that support the progression of the Biopharm R&D portfolio. Failure of a large scale cell culture or purification processes has ramifications throughout research, development, and clinical organizations.

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 a minimum two (2) years relevant industrial experience, or B.S. in these disciplines with a minimum of four (4) years of relevant 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 OR Lab/pilot scale protein purification methods, including chromatography, ultrafiltration/diafiltration, depth filtration, centrifugation and buffer preparation.

• Experience in cGMPs and regulatory requirements.

• Experience in process technology transfer, process scale-up and manufacturing operations.

• Excellent troubleshooting/problem analysis skills. Experience with Lean Sigma and/or Root Cause Analysis methodologies.

If you have the following characteristics, it would be a plus:

• Good written and oral communication 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.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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