PRINCIPAL OBJECTIVE OF THE POSITIONTo 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 superior team, effectively managing personnel issues and planning and administering financial resources.
- Adaptable to a fast paced, complex and ever changing business environment.
- Effective communication skills with support groups in the coordinating system to obtain needed cooperation and support as required in a timely and effectively manner.
- Demonstrated strong track record for change management including implementation of continuous improvement / OPEX strategies.
- Budget awareness and a strong acumen for cost reduction and efficiency realisation in the business unit and at site level
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:Devens - MA - US: $194,860 - $236,128
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We WorkWhere you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
