Lead and drive execution of manufacturing processes for cell therapies under cGMP, manage a team, ensure compliance, and implement continuous improvement.
Compensation
Bothell - WA - US: $113,930 - $138,051
Responsibilities
Manage creation, implementation and compliance of all Source Governing Documents for cell therapy operations
Oversee operations within a validated manufacturing system
Plan, assign resources and oversee daily operational activities while controlling costs
Maintain operating and storage areas to ensure compliance, efficiency, safety and inspection readiness
Drive right-first-time initiatives and hold team accountable for compliance performance
Requirements
Bachelor's degree in relevant science or engineering discipline
Lead senior quality leadership for design, integration, and execution of complex remediation programs at Round Lake Drug Delivery.
Compensation
The estimated base salary for this position is $112,000 - $154,000 annually.
Responsibilities
Lead development, integration, and execution of site remediation strategies arising from regulatory inspections, Warning Letters, OAI classifications, health-authority commitments, audits, quality-system assessments, and significant recurring quality signals.
Translate commitments and identified gaps into clearly defined workstreams, accountable owners, milestones, dependencies, deliverables, interim controls, effectiveness measures, and objective closure evidence.
Establish and maintain a risk-based remediation master plan and governance cadence that provides clear visibility to progress, overdue actions, critical-path constraints, resource needs, decision requirements, and emerging risks.
Provide independent Quality oversight and constructive challenge to ensure remediation plans are technically sound, scientifically justified, regulatorily defensible, feasible, and aligned with commitments made to health authorities and internal governance bodies.
Drive cross-functional execution across Quality, Manufacturing, Engineering, Maintenance, Facilities, Laboratories, Supply Chain, Regulatory Affairs, IT, Training, and Operational Excellence to remove barriers and maintain alignment.
Lead enterprise process engineering strategy, standards, and governance for biologics drug substance and cell and gene therapy manufacturing across AbbVie’s Strategic Investment portfolio.
Responsibilities
Set enterprise engineering standards and governance for biologics and CGT process engineering
Drive consistent application of technical standards across regions, sites and capital projects
Provide engineering leadership for strategic capital investments and new technology deployments
Coordinate technical input from project teams, vendors and cross-functional stakeholders
Ensure engineering deliverables support safety, quality, compliance, operability, maintainability, reliability, sustainability and operational readiness
Requirements
Bachelor’s degree in Engineering, Science or a relevant technical discipline
Nice to have: Advanced degree in Engineering or related field
Nice to have: Experience with viral vector, mRNA, sterile biologics
Nice to have: Experience in regulated biopharmaceutical manufacturing environments
Support manufacturing operations for clinical and commercial cell therapy programs through the execution of cGMP‑compliant production activities.
Compensation
The anticipated hourly rate for this position in NJ is $40.86 – $45.67 plus bonus. The final hourly rate offered to a successful candidate may vary and will depend on factors such as experience, skillset, education, and business needs.
Responsibilities
Support manufacturing operations for clinical and commercial cell therapy programs
Coordinate daily production scheduling and resource planning in partnership with Manufacturing leadership
Execute and oversee key manufacturing processes, including cell culture, aseptic processing, cell expansion, separation, counting, and cryopreservation
Assist with the development, review, and maintenance of manufacturing documentation, including SOPs, work instructions, forms, and protocols
Train and mentor Manufacturing Associates in technical operations, aseptic techniques, and cGMP requirements
Requirements
High School Diploma
Associate degree in a scientific, engineering, or biotechnology discipline
Bachelor’s degree in a scientific or engineering discipline
Assist in developing the structure to aseptically operate Formulation, Wash/Sterilization, Filling & media preparations through documentation, start-up and validation activities for a new production facility.
Compensation
Leading pay and annual performance bonus for all positions
Responsibilities
Review & author Job Instructions, SOP’s & other documents
Assist in the start-up and validation of new equipment
Review standards to maintain aseptic areas & perform sanitizations & environmental monitoring
Support event response planning
Assist maintenance team in the development of protocols for restoration of lost function, predictive & preventative maintenance
Remediation LeadBaxter International Inc. · Round Lake, US
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QA Sterility Assurance Leadten23 health AG · Visp, Switzerland