Senior Scientist Downstream Process Development Jobs in Raleigh, NC

What You Will Do

• Lead and develop the Process Owner organization responsible for providing technical process stewardship and manufacturing support for Upstream, Downstream, and Services Drug Substance Unit Operations.

• Provide direct management, coaching, mentoring, and career development for Process Owners.

• Develop and implement a swing-shift Process Owner organization to provide expanded manufacturing support and floor coverage.

• Foster a culture of safety, quality, compliance, accountability, collaboration, operational excellence, and continuous improvement.

• Provide strategic leadership for process ownership, operational readiness, manufacturing change implementation,manufacturing procedures, manufacturing CAPAs,and technical process stewardship.

• Coordinate with site scheduling to ensure Process Owners provide timely hyper-care support and technical assistance during manufacturing campaigns, startup activities, process changes, first-time executions, and routine operations.

• Serve as the primary interface between Manufacturing Operations and support organizations including Quality, Engineering, Process Development, C&Q, Supply Chain, and Digital Manufacturing.

• Oversee execution of dry runs, water runs, engineering runs, and operational readiness activitiessupporting manufacturing.

• Own manufacturing-relatedCAPAs andchange controls associated with process, procedural, and operational improvements.

• Provide leadership andinputfor electronic batch record (EBR) and manufacturing execution system (MES) implementation activities impacting manufacturing operations.

• Partner withTechnologyteams to ensure manufacturing processes are effectively translated into digital workflows and manufacturing execution platforms.

• Partner with Supply Chain organizations to ensure manufacturing processes, material strategies, and Bill of Materials(BOM) support efficient manufacturing execution.

• Provide process ownership oversight for BOM creation, maintenance, and updates associated with manufacturing process changes.

• Ensure creation, revision, maintenance, and periodic review of GMP documentation supporting manufacturing operations.

• Drive strategic initiatives to improve process reliability, manufacturing efficiency, operator experience, and operational performance.

• Support inspection readiness activities and represent the Process Owner organization during audits and regulatory inspections as required.

Win

What We ExpectofYou

Basic Qualifications:

Doctorate degree and 2 years of biotechnology or pharmaceutical industry experience
OR
Master's degree and 6 years of biotechnology or pharmaceutical industry experience
OR
Bachelor's degree and 8 years of biotechnology or pharmaceutical industry experience
OR
Associate's degree and 10 years of biotechnology or pharmaceutical industry experience
OR
High school diploma / GED and 12 years of biotechnology or pharmaceutical industry experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• 8+ years related work experience in biotechnology or pharmaceutical manufacturing with progressively increasing responsibility.

• Prior people leadership experience managing and developing technical teams.

• Strong understanding of GMP manufacturing operations supporting Upstream, Downstream, and Services Drug Substance Unit Operations.

• Experience with process ownership, manufacturing support, and technical process stewardship.

• Experience supporting digital manufacturing systems, electronic batch records (EBRs), manufacturing execution systems (MES), and associated process implementation activities within a GMP manufacturing environment.

• Experience authoring, approving, and governing manufacturing SOPs and GMP documentationwithinQuality Systems (i.e. Veeva,Documentum, etc.).

• Experience leading manufacturingCAPAs/change controls and implementation activities.

• Experience supporting operational readiness activities, including dry runs, water runs, process implementation, and startup support.

• Experience partnering with Supply Chain organizations to support BOM management, material readiness, and manufacturing execution.

• Excellent organizational, written, verbal communication, and cross-functional leadership skills.