The Manager, Manufacturing is responsible for the day-to-day execution of chemistry and bioconjugation cGMP manufacturing operations at the Bristol site. This role ensures that production activities are completed safely, on schedule, and in compliance with cGMP standards.
The Manager is accountable for frontline leadership, execution of the production plan, and immediate problem solving to maintain operational performance. This role operates primarily on the manufacturing floor and drives performance through direct team engagement and Tier 1 accountability.
Responsibilities
Operational Execution
• Execute the daily manufacturing schedule and ensure alignment to the production plan
• Allocate personnel and resources to meet operational needs
• Lead Tier 1 daily operations meetings and escalate issues as required
• Monitor progress throughout the shift and adjust resources to maintain schedule adherence
• Manage multiple activities across chemistry and bioconjugation operations
Compliance and Quality
• Ensure all manufacturing activities comply with cGMP, FDA, and internal procedures
• Perform daily review of batch records and logbooks for accuracy and completeness
• Initiate and support deviations, CAPAs, and change controls
• Escalate quality and compliance risks to leadership in a timely manner
People Leadership
• Supervise and develop manufacturing staff, including supervisors and operators
• Ensure training is current and aligned with job responsibilities
• Reinforce a culture of safety, accountability, and adherence to procedures
• Address performance issues and support employee development
Operational Readiness
• Ensure equipment, materials, and documentation are available to support operations
• Identify gaps in readiness and coordinate with support functions to resolve
• Support troubleshooting of process and equipment issues
Cross-Functional Collaboration
• Partner with Quality, MSAT, Supply Chain, and Engineering to support execution
• Communicate production status, risks, and needs to stakeholders
• Support audits, client visits, and internal reviews as required
Continuous Improvement
• Identify and implement improvements to increase efficiency and reduce errors
• Support Lean and Six Sigma initiatives
• Contribute to improvements in batch records and procedures
Projects and Tech Transfer
• Support technology transfer activities from development to manufacturing
• Execute assigned projects and provide status updates to management
General Responsibilities
• Operate in alignment with company policies and ethical standards
• Communicate clearly and effectively across teams
• Work collaboratively to support site objectives
Qualifications
• BS or MS in Chemistry, Biochemistry, Engineering, or related field
• Minimum 5 to 10 years of experience in cGMP manufacturing
• Prior supervisory experience required
• Strong troubleshooting ability for process and equipment issues
• Ability to manage multiple priorities in a fast-paced environment
• Experience with Lean manufacturing or Six Sigma preferred
Physical Requirements
• Ability to stand or walk for extended periods
• Ability to lift up to 50 pounds
• Ability to work on the manufacturing floor for the duration of shift
FLSA: Exempt
