Single Use Facility, Manufacturing Manager

Bristol-Myers Squibb; Harvard (MA); On-site; USD 105,000 - 127,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support

Financial Well-being and Protection

Job summary

Bristol Myers Squibb in Devens, MA is seeking a Shift Manager to lead the execution of commercial manufacturing processes for therapeutic proteins, ensuring adherence to cGMPs and high-quality outcomes. You'll guide a team, drive on-the-floor problem solving, and partner with engineering and quality groups to maintain schedule and safety.

This role requires a BS in science or engineering, 6+ years of biotech manufacturing experience, and proven leadership.

Qualifications

• B.S. in science, engineering, biochemistry or related discipline.
• 6+ years of direct biologic manufacturing experience.
• Proven supervisory or leadership experience.
• Extensive knowledge of SOPs and cGMPs in regulated environments.
• Strong communication and technical writing skills.

Responsibilities

• Oversee execution of manufacturing unit operations.
• Lead training and troubleshooting on the floor.
• Manage shift scheduling and staffing.
• Ensure compliance with GMP and SOPs.
• Collaborate with cross-functional teams and engineers.

Skills

Biologic manufacturing

Team leadership

SOPs & cGMPs

Problem solving

Effective communication

Education

B.S. in science/engineering

Tools

Delta V

Syncade

SAP

OSI Historian

Veeva Vault

Maximo

Job description

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Summary

The Shift Manager leads and drives the execution of commercial manufacturing processes according to established electronic work instructions and production records for the manufacture of therapeutic proteins in accordance with Current Good Manufacturing Practices (cGMP's). The Shift Manager is responsible for management of a group whose primary focus is on execution of manufacturing processes, technical assessment of processes, maintaining a culture of compliance, innovation, and within their functional group. The Shift Manager is required to guide the personnel in their group with knowledge and technical knowledge to lead troubleshooting activities, provide investigation support, analyze process/equipment data, and identify and implement process improvements.

Major Duties and Responsibilities

• Provides direct oversight of the execution of manufacturing unit operations.
• These operations include but are not limited to the use of the following equipment and or systems: i.e., bioreactors, chromatography systems, media/buffer preparation equipment etc.), process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and supporting business systems (i.e. SAP. Veeva Vault, Maximo etc.).
• Drives right first time (RFT) execution of manufacturing unit operations by providing direct training, guidance, and problem solving on the floor in real time.
• Takes an active role in selecting and developing the team. This includes leveraging both internal and external relationships to build the best team possible.
• Ensures team adherence to Good Manufacturing Practices and standard operating procedures.
• Ensures daily work coordination and distribution as demanded through the manufacturing schedule.
• Is responsible for maintaining schedule adherence and cycle time.
• Reports variances and communicates impact to cross functional groups.
• Manage daily communication to shift personnel.
• Supports and drives shift huddles and functional team meetings.
• Provides shift handover and communication working with other shift team members.
• Ensures oversight for critical operations through systematic walk down and checks of equipment and functional areas prior to execution.
• Review critical attributes and drive decisions.
• Build partnership with Manufacturing Operational Engineer Support to ensure daily data review and trends accomplished seamless operations.
• Provide critical communications upwards, downward and across as deemed fit.
• Ensure shift notes communication is complete and accurate.
• Provide critical update summary to the staff for all safety incidents and significant process deviations.
• Initiates response team for critical issues, managing team progress and providing detailed communication to management.

Knowledge and Skills

• 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.
• Direct biologic manufacturing experience of 6+ years.
• Supervisory and or leadership experience which demonstrates proficiency in selection of team and effectively managing personnel issues is highly desired.
• Extensive knowledge of SOPs and cGMPs within a regulatory environment.
• Knowledge of pharmaceutical and biopharmaceutical manufacturing process with participation in pharmaceutical technology, technology transfer, process development, manufacturing support.
• Adaptable to a fast paced, complex and ever-changing business environment.
• Effective communication and technical writing skills with support groups in the coordinating system to obtain needed cooperation and support as required in a timely and effectively manner.

Compensation Overview

Devens - MA - US: $104,975 - $127,205 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment.

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and