Bristol-Myers Squibb Company
New Brunswick, NJ, United States
Manager, Engineering, Sciences
Apr 01, 2020
Bristol Myers Squibb
Associate Director, Parenteral ExM MS&T
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
The Associate Director MS&T External Manufacturing Parenteral Drug Product will lead technical support for Parenteral manufacturing of BMS Sterile and biologic drug products at Contract Manufacturing Organizations (CMO's) in the US, and Globally. The individual may lead a small team of engineers and scientists to execute technical transfer and process maintenance activities at the CMO's.
This position will report into the Head of Parenteral ExM Manufacturing Science and Technology; This position is located in New Brunswick, NJ
Participation in CMO/vendor selection and strategy with Procurement, Quality, and other business functions.
Oversight and/or preparation of technical information packages, participation in due diligence and site assessments, technical evaluation of Supplier Proposal requests (RFP), and other business agreements.
Technical Transfer leadership to contract manufacturing organizations. This includes development and Sr. Management Endorsement of process development, comparability demonstration, and global registration strategies to support CMO implementation.
Review and approval of top-level site technology documents such as Validation Master Plans, Process Risk assessments, etc.
Leadership and hiring of small technical team of permanent and/or contract scientists/engineers to provide Person-in-Plant support for technical transfers and commercial manufacturing according to business agreements.
Provision of ongoing technical support and oversight for a portfolio of externally manufactured products, ensuring consistent security of supply, this includes technical approval of change control proposals and review of manufacturing and process investigations
Management of Process Owner Role at contract manufacturing sites. This includes process capability analysis and Continuous Process Verification of key quality attributes and parameters at the CMO, identifying and executing process robustness improvement projects where required. Use of this knowledge to ensure timely, comprehensive and accurate process data reviews and to support generation of Annual Product Quality Review documents.
Advanced technical support and scientific communication to Global Health Authorities in support of CMC preparation, CMC query resolution, and plant inspections.
Employment of resources and processes (OPEX etc.) to improve processing efficiency and to ensure optimized technical support for manufacturing, technical transfer and scale-up of processes to commercial scale.
Technical Expert in Biologics/sterile/liquid drug product (Lyo and RTU), unit and inspection operations.
Demonstrated successes with Technology Transfer and scale up of commercial manufacturing processes.
Thorough knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design and process control fundamentals.
Strong understanding of project management systems and tools
Thorough understanding of regulations, familiarity of regulatory environment and industry trends for parenteral drug products
Working competency of Statistical Process Control and related tools.
Very strong technical writing and verbal communication, as well as leadership experience.
Demonstrated ability to:
influence areas not under direct control to achieve objectives
work strategically, manage multiple programs and create a high-performance work environment.
work in a matrix environment and effectively support the decentralized manufacturing function
build alignment with business partners including R&D and manufacturing regional and site leaders
manage risk and make rapid decisions
budget, plan and manage resources efficiently
Strong strategic and analytical thinking, problem solving and rapid decision-making skills.
Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous environment.
Strong ability in negotiating and influencing without authority in complex, high impact situations.
Demonstrated proficiency in competency areas of Strategic Agility, Organizational Agility, Business Acumen, Process Design and Management, Organization Change Management and Process Effectiveness - in globally diverse, rapidly changing cross cultural environment.
Demonstrated ability in technical writing, computer knowledge and communication skills is required.
Strong presentation and communication skills both, oral and written.
The position will require varying levels of travel- estimated at 30%.
Required Qualification(s) and Desired Experience
Strong technical knowledge of sterile products development and manufacturing technology, with a minimum of 10 years of experience in Parenterals is required.
A bachelor's degree in relevant engineering or science discipline (chemical/bioprocess engineering, biochemistry, Pharmaceutical Sciences, microbiology or a related pharmaceutical science) is required. Masters and or PhD level degree is strongly preferred.
BMS BioPharma Behaviors
The qualified candidate demonstrates characteristics of our BMS Behaviors. For more details, refer to InSite BMS Website/ People and Performance/BMS Behaviors.
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 the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb Company
Website : http://www.bms.com