Single Use Facility, Manufacturing Manager
$104,975–$127,205 year
On-siteDevens, Massachusetts, United States
Job Summary
Lead the execution of commercial manufacturing processes for therapeutic proteins in accordance with cGMPs, overseeing bioreactors, chromatography systems, and process automation tools like Delta V and Syncade. Drive right-first-time execution by providing real-time floor guidance, troubleshooting support, and data analysis to identify and implement process improvements. Manage daily shift coordination, enforce adherence to standard operating procedures, and lead shift huddles and functional meetings while ensuring accurate shift notes and critical communication across cross-functional groups. Initiate response teams for significant process deviations and safety incidents, reporting variances to management. Requires a B.S. in science or engineering, 6+ years in direct biologic manufacturing, and extensive SOP/cGMP knowledge. Located in Devens, MA, with a salary range of $104,975 - $127,205.
Required Qualifications
- B.S. in science, engineering, biochemistry or related discipline, or its equivalent
- Direct biologic manufacturing experience of 6+ years
- Supervisory and or leadership experience
- Extensive knowledge of SOPs and cGMPs within a regulatory environment
- Knowledge of pharmaceutical and biopharmaceutical manufacturing process
- Experience with technology transfer, process development, and manufacturing support
- Knowledge of bioreactors
- Knowledge of chromatography systems
- Knowledge of media/buffer preparation equipment
- Knowledge of process automation systems (Delta V, Syncade Interactions, OSI/Pi Historian)
- Knowledge of supporting business systems (SAP, Veeva Vault, Maximo)
- Adaptability to a fast paced, complex and ever-changing business environment
- Effective communication skills
- Technical writing skills
- Ability to provide direct training, guidance, and problem solving on the floor in real time
- Ability to select and develop team members
- Ability to leverage internal and external relationships
- Ability to ensure adherence to Good Manufacturing Practices and standard operating procedures
- Ability to ensure daily work coordination and distribution as demanded through the manufacturing schedule
- Ability to maintain schedule adherence and cycle time
- Ability to report variances and communicate impact to cross functional groups
- Ability to manage daily communication to shift personnel
- Ability to support and drive shift huddles and functional team meetings
- Ability to provide shift handover and communication working with other shift team members
- Ability to ensure oversight for critical operations through systematic walk down and checks of equipment and functional areas prior to execution
- Ability to review critical attributes and drive decisions
- Ability to build partnership with Manufacturing Operational Engineer Support
- Ability to ensure daily data review and trends accomplished seamless operations
- Ability to provide critical communications upwards, downward and across
- Ability to ensure shift notes communication is complete and accurate
- Ability to provide critical update summary to the staff for all safety incidents and significant process deviations
- Ability to initiate response team for critical issues
- Ability to manage team progress
- Ability to provide detailed communication to management
- 100% of shifts onsite at assigned facility
- Ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed
Desired Qualifications
- Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is highly desired
- Supervisory and or leadership experience which demonstrates proficiency in selection of team and effectively managing personnel issues is highly desired
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