Digital Process Specialist

GSK•Marietta, PA

6d•Onsite

About The Position

You will lead the strategy for the use of digital batch records with Mendix Clinical Batch Record (CBR) at the Upper Merion East (UME) biopharm pilot plant and other US pilot plants, including the implementation of future system capability enhancements and implementation at new sites. Expertise in manufacturing processes, digital batch records, and GMP requirements will enable you to shape the digitization of manufacturing across clinical supply chain sites. The role offers opportunities for cross-functional leadership, interfacing with a global team, and directly influencing the speed and quality at which GSK delivers medicine to patients.

Requirements

B.S. in a technical discipline (engineering, life sciences, computer sciences, etc.) with a minimum four (4) years relevant experience in one of the following areas: Manufacturing execution systems used in drug substance or drug product manufacturing
Lab/pilot/commercial scale pharmaceutical operations (biopharm cell culture or purification, small molecule, drug product, etc.)
Experience in using digital tools for lab or pilot plant applications
Experience in cGMPs and regulatory requirements.
Experience in project management and delivery, including ability to prioritize and forward plan courses of action.

Nice To Haves

Ph.D. in a technical discipline (engineering, life sciences, computer sciences, etc.) or M.S. in these disciplines with a minimum two (2) years relevant experience, in one of the following areas: Manufacturing execution systems in drug substance or drug product manufacturing
Lab/pilot/commercial scale pharmaceutical operations (biopharm cell culture or purification, small molecule, drug product, etc.)
Experience in implementing a new digital system and integrating/maintaining it within a business function.
Experience in Mendix, low-code application development platforms, or other related digital application with demonstrated experience in solution development, testing, and/or validation.
Experience in multiple areas within pharmaceutical process development, technology transfer, scale-up, process engineering, and/or cGMP batch execution, including experience across multiple functions or modalities (biopharmaceutical drug substance, drug product, ADCs, oligonucleotides, small molecules).
Excellent troubleshooting/problem analysis skills, including experience with Lean Sigma and Root Cause Analysis methodologies.
Strong interpersonal and leadership skills.
Solid team player able to function within collaborative- and team-based organization.

Responsibilities

Acts as the US business subject matter expert and a technical resource for the use of digital batch records.
Supports users in performing activities in CBR, incident resolution, and proposes design improvements to the CBR Global Team based on business needs.
Responsible for driving the training strategy and providing guidance to pilot plant staff.
Monitors and maintains the use of digital batch records for production at UME and other US sites.
Informs teams of system updates, escalates issues to global team, supports batch record development and testing for new processes, and authors/updates global and local procedures as needed.
Accountable for successful delivery of new batch records or batch record steps for new manufacturing capabilities and modalities using CBR.
Works collaboratively with business stakeholders to gather feedback, perform testing, and deliver successful design. This includes new process actions or process recipe details.
May provide support to assess/implement integration with other digital tools such as digital technology transfer, connected equipment, data products, and dashboarding.
Leads activities to assess and implement system enhancements including workshops, gap analyses, development of user requirements, documentation assessments, and local change controls as needed.
Could lead local deviations/CAPA/remediations/management monitoring related to CBR.
Recommends and reviews new technical developments for the system.
Contributes to user story creation, influences technical roadmap, participates in technical demonstrations with developers, and supports prioritization of new features.
May perform testing activities in Mendix.
May play a leadership role for audit readiness or specific cGMP compliance/readiness projects (i.e. new capability in Mendix platform).
In addition to CBR, responsibilities may also include leading technology transfers as part of maintaining business process knowledge.
Leads technology transfer from, and coordinates activities between, bioprocess development groups (internal and/or external) to the UME Pilot Plant or third-party contract manufacturers.
Represents the department in CMC and other Matrix teams.
Presents campaign results/conclusions and contributes to the decision-making process within these teams.
Conducts facility fit assessments and leads process introduction activities.
Responsible for authoring and approval of technical batch documentation, including digital batch record design.
Ensures that processes being transferred to pilot plant and supporting documentation are sufficient to support consistent production and regulatory filings.
Troubleshoots production issues and is accountable for the technical success of multi-million-dollar biopharmaceutical production campaigns that support progression of the Biopharm R&D portfolio.
Ensures that manufacturing campaign data and supporting information is sufficient to support regulatory packages and filings.
Uses modern data science tools and techniques to compile and analyze campaign data and recommend follow up actions.
Authors manufacturing and process sections of regulatory submissions and responses to Health Authority questions.