Director, Manufacturing Operations

Bristol Myers Squibb; Harvard (MA); On-site; USD 180,000 - 280,000; Full time

Job summary

Bristol Myers Squibb seeks a senior manufacturing leader to direct Upstream/Downstream operations, drive production targets, and ensure cGMP compliance for biologics manufacturing. You will manage a large, diverse team and align schedules with supply chain needs while advancing process improvement and capital efficiency.

Responsibilities include safety leadership, cross-functional collaboration, and delivering on New Product Introductions in a fast-paced biotech environment.

Qualifications

• Knowledge of SOPs, cGMPs and know-how to work within a regulatory environment.
• Extensive knowledge of pharmaceutical and biopharm manufacturing processes and tech transfer.
• Experience managing large teams (>30 people).
• Aptitude for engineering principles and manufacturing automation systems.
• Ability to influence in a matrixed environment.
• Proven managerial experience in selection, motivation and retention of staff.

Responsibilities

• Directs all activities in Upstream or Downstream Operations.
• Allocates departmental resources to deliver production targets and manage turnover/training.
• Accountable for multiproduct operations including New Product Introductions.
• Owns detailed work schedules aligned with supply chain demand and site programs.
• Drives safety leadership and ensures CAPA closure.
• Ensures cGMP performance and regulatory compliance.
• Maintains audit readiness for facility and SME.

Skills

Leadership

Regulatory compliance

Project management

Manufacturing operations

cGMP knowledge

Team building

Process optimization

Communication

Education

B.S. in science/engineering

M.S. or related field preferred

Tools

Process automation software

SPC

Quality systems (LIMS/MES)

Job description

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

PRINCIPAL OBJECTIVE OF THE POSITION

To direct the execution of clinical and/or commercial manufacturing processes according to established work instructions and production records for the manufacture of therapeutic proteins in accordance with current Good Manufacturing Practices (cGMPs).

MAJOR DUTIES AND RESONSI-BILITIES

• Directs all activities in Upstream or Downstream Operations
• Allocates departmental resources (equipment, labor and inventories) to deliver production targets, reduce operating costs, increase area throughput and manage turnover/training.
• Accountable for multiproduct operations including New Product Introductions into the Upstream or Downstream areas.
• Accountable for delivery of commercial products such as Orencia, Empliciti or Opdualag and/or the Biologics clinical pipeline.
• Accountable for Cryogenics operations (LSCC Upstream Director) and Cell Bank Facility operations (Upstream SUF Director
• Owns generation of detailed work schedules (finite scheduling) of manufacturing operations - aligned with supply chain demand and site programs for new product introduction.
• Embraces and effectively communicates the company, site and department mission, goals and guidelines, undertaking supportive actions which contribute to the fulfillment of these values and objectives while contributing to cultural evolution, innovation and leadership within the organization.
• Drives safety leadership in pursuing the vision of an injury free operations environment and ensures that any safety investigations and CAPAs are closed in a prompt manner.
• Owns and drives cGMP performance to meet or exceed regulatory agency requirements related to Biologics manufacturing and assures compliance with BMS directives in training, quality management systems, policies, change control, and on-time closure of investigations and CAPAs.
• Maintains audit readiness at all times for both the facility and subject matter expertise.
• In collaboration with MS&T, Engineering and Manufacturing staff, identifies trends, variances and bottlenecks in the manufacturing process and assists in the development of solutions to maximize productivity, quality and process efficiency.
• Coordinates resources from the supporting organizations (QA/QC, MS&T, Digital Plant, Supply Chain, Human Resources, Site Engineering, etc.) as needed to support the core manufacturing process. Recruits and develops a high performing team with diverse backgrounds and talents.
• Coaches and counsels team members to develop their skill sets and create an environment of continuous learning, improvement, and innovation. Develops and adopts metrics that accurately measure and sustain the manufacturing strategies and drive team performance.
• Ensures proper communication and escalation within the established tier process to drive and sustain accountability for the value stream.
• Maximizes the use of existing capital committed to the manufacturing process by eliminating waste, improving productivity and controlling work-in-progress levels.
• Establishes an environment which fosters continuous improvement in cost, quality, safety and customer service.
• Builds and maintains strong relationships inside and outside the organization.
• Manage critical interfaces with key stakeholders to foster a unified and strongly aligned approach to delivery of drug substance.

KNOWLEDGE AND SKILL

• Knowledge of science generally attained through studies resulting in a B.S. or higher degree in science, engineering, biochemistry or related discipline, or its equivalent
• Mastery of SOPs, cGMPs and know-how to work and manage within a regulatory environment.
• Extensive knowledge of pharmaceutical and biopharmaceutical manufacturing process with experience and knowledge of pharmaceutical technology, technology transfer, process development, manufacturing support.
• Experience with management of large teams (>30 people), including direct and indirect reports, strongly preferred.
• Demonstrated aptitude for engineering principles and manufacturing automation systems.
• Demonstrated ability to change the thinking of or gain acceptance of others in sensitive situations.
• Proven leadership ability to make difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment.
• Previous managerial experience which demonstrates proficiency in selection, motivating and retaining a s