Senior Manager, Manufacturing Aseptic Process Leader

General Description:

The Manufacturing Aseptic Process Leader serves as the functional owner and technical leader for aseptic manufacturing operations. This role is responsible for developing and sustaining a culture of aseptic excellence across filling, lyophilization, component preparation, and cleanroom operations.

The position partners closely with Quality Assurance, MSAT, Validation, Engineering, and QC Microbiology to ensure robust contamination control, inspection readiness, operational excellence, and reliable commercial supply.

This role focuses on operational execution, aseptic behaviors, process performance, training effectiveness, and continuous improvement within manufacturing operations.

Essential Functions of the Job:

Aseptic Operations Leadership

• Serve as the manufacturing subject matter expert for aseptic processing.

• Lead technical execution of Aseptic filling operations, Isolator operations, Lyophilization processes, Sterile component preparation and transfer

• Provide on-floor leadership and support during critical manufacturing activities.

• Establish and maintain best practices for sterile manufacturing execution.

Aseptic Culture & Behavior

• Develop a culture of aseptic discipline and contamination awareness.

• Lead routine observation and coaching of manufacturing personnel.

• Ensure adherence to Aseptic techniques, Cleanroom behaviors, Gowning requirements and Material transfer practices

• Drive continual improvement of operator qualification programs.

• Partner with QA and Training to strengthen operator readiness.

Media Fill and Process Simulation Support

• Support design and execution of Media fills, Process simulations and Operator qualification activities

• Lead manufacturing readiness efforts before media fill execution.

• Support investigation and remediation following media fill events.

• Implement lessons learned across manufacturing operations.

Manufacturing Excellence

• Drive improvement initiatives that enhance Process reliability, Batch success rates, Throughput, Right-first-time performance, Schedule adherence

• Support implementation of Lean Manufacturing and Operational Excellence strategies.

• Lead root cause analysis of aseptic-related operational issues.

Contamination Control

• Partner with Quality Assurance and QC Microbiology to strengthen contamination control practices.

• Participate in contamination investigations and technical assessments.

• Review environmental monitoring trends with manufacturing teams.

• Implement corrective actions aimed at reducing contamination risk.

• Support implementation of the site Contamination Control Strategy.

• Provide oversight and training, when necessary, to Aseptic Cleaning staff

Technology Transfer and Process Validation

• Support commercialization of new products and technology transfer activities.

• Provide manufacturing expertise during CQV, PPQ, Process validation, Facility startup activities

• Ensure manufacturing readiness prior to qualification and commercial campaigns.

Regulatory Inspection Readiness

• Support health authority inspections and customer audits.

• Serve as manufacturing SME during inspections related to Aseptic processing, Media fills, Operator qualification and Manufacturing controls

• Maintain inspection-ready manufacturing practices and documentation.

Leadership Responsibilities

• Coach supervisors, managers, and operators.

• Establish clear performance expectations regarding aseptic discipline.

• Partner across functions to resolve complex operational challenges.

• Promote BeOne leadership behaviors and a culture of accountability.

Technical Expertise

• Aseptic Processing

• Annex 1 implementation

• Sterile Manufacturing Operations

• Isolators

• Lyophilization

• Media Fills

• Cleanroom Operations

• Risk Assessments (FMEA)

• Root Cause Analysis

• CAPA and Deviation Management

• Process Validation

• Lean Manufacturing

• Operational Excellence

Required Experience/Education:

Education:

• Bachelor’s degree and 7+ years of sterile pharmaceutical, biologics, vaccine, or cell therapy manufacturing experience required

• Master’s degree and 5+ years of sterile pharmaceutical, biologics, vaccine, or cell therapy manufacturing experience required

Supervisory Responsibilities:

• 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Travel: Up to 10%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.