Specialist Manufacturing – Process Owner - Upstream / Downstream / Services
Core
Technical process steward and key interface between Manufacturing Operations and support organizations, responsible for supporting manufacturing execution, floor support, operational readiness, and continuous improvement in drug substance manufacturing.
Role type
Specialist Manufacturing – Process Owner (Upstream/Downstream/Services)
Builds
Drug substance manufacturing processes using disposable technologies and stainless-steel equipment at the FleX Batch facility.
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
GMP documentation authoring, process governance, troubleshooting, root cause analysis, risk assessment, change control support, MES/EBR support, single-use technology knowledge, BOM alignment
Preferred skills
Upstream/Downstream/Manufacturing Services expertise, drug substance manufacturing knowledge, floor operations support, operational readiness activities, CAPA implementation, risk mitigation, technical writing
Technologies
MES, EBR, single-use assemblies, consumables
Responsibilities
Serve as technical process owner for assigned manufacturing processes and unit operations; Provide manufacturing floor support, troubleshooting assistance, and hypercare during routine operations and startup activities; Support operational readiness activities including water runs, dry runs, and equipment readiness verification; Author, revise, review, and maintain manufacturing SOPs and GMP documentation; Monitor process performance and identify opportunities for optimization and risk reduction; Support manufacturing-related change controls and implementation activities; Participate in root cause analysis activities and support manufacturing investigations and quality events; Support CAPA applicability assessments and implementation activities; Partner with Process Development, Supply Chain, and Engineering to support material readiness and BOM alignment; Support MES and EBR activities by providing process expertise; Participate in inspection readiness activities and support audits as required.
Seniority
Specialist, hands-on IC