Associate Director, Parenteral ExM MS&T

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 rich in diversity. 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.

Job Function

Associate Director, Parenteral MS&T will lead technical support for parenteral manufacturing of BMS products at Contract Manufacturing Organizations (CMO's) primarily based in the US. This position is accountable for the technical interface with Quality, Procurement, Supply Chain, External Manufacturing and Contract Manufacturing Organization (CMOs) to support commercial manufacturing, projects and Technology Transfers for parenteral products. The individual will lead a team of engineers and scientists and will work directly with CMO's. This position is located in New Brunswick, NJ

Responsibilities

• Leadership and hiring of a small technical team of permanent and/or contract scientists/engineers to provide Person-in-Plant support for technology transfers and commercial manufacturing according to business agreements.

• Technical direction and oversight for the External manufacturing (ExM) parenteral network ensuring the delivery of business objectives with our external partners in terms of product delivery.
• Responsible for commercial manufacture support for the ExM parenteral network including resolution of complex technical investigations, change control implementation, delivery of operational targets and technical strategies.

• Management of Process Owner Roles for commercial manufacture support for the ExM parenteral network. 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.

• 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. 
• Provides leadership and technical oversight for technology transfer projects or other related projects in the parenteral ExM environment. Review and approval of top-level site technology documents such as validation masterplans, process risk assessments, etc.
• Member of the global MS&T parenteral team and will have responsibility for driving continuous improvement across the ExM network and within MS&T parenteral aligning with quality and regulatory requirements.
• Optimization of business processes and ways of working to drive team and network performance.
• Review and approval of CMC documentation for health authority responses and regulatory filings.

• Establish relationships to foster collaboration with key stakeholders in partner organizations. Routinely liaising within the MS&T internal BMS network for technical and operational improvements and investigation resolution.

• Participates actively within the extended leadership team to establish team objectives while undertaking supportive actions to drive global network initiatives.
• Role may include balancing multiple responsibilities such as technical oversight of a commercial brand along with oversight of external commercial manufacturing. Leadership and hiring of a small technical team of permanent and/or contract scientists/engineers to provide Person-in-Plant support for technology transfers and commercial manufacturing according to business agreements.
• The position will require varying levels of travel- estimated at 25%.

Required Competencies

• Thorough knowledge of relevant aspects of biologics/sterile/liquid parenterals (Lyophilisation and RTU), fill, finish and inspection operations and associated Quality and Regulatory expectations for filing, approval and Continued Process Verification (CPV).
• Demonstrated successes with Technology Transfer and scale up of commercial manufacturing processes
• Proven ability to work on complex problems in which analysis of situations or data requires an in-depth evaluation of multiple factors is required. Working competency of Statistical Process Control and related tools.
• Proven ability to apply risk-based thinking to resolve issues and drive decisions while maintaining a strong compliance focus is also required.
• Demonstrated strong leadership in a matrixed environment, communication, organizational and project management skills are required for this role.
• Proven managerial skills in building high performing teams through effective resource planning and execution are essential; highly effective leadership skills and capabilities are required for this position.
• Thorough understanding of regulations, familiarity of regulatory environment and industry trends for drug products
   

Required Qualification(s) and Desired Experience

• Strong technical knowledge of sterile products development and manufacturing technology, with 10 years of experience in parenterals is required.
• A bachelor's degree in a relevant engineering or science discipline (chemical/bioprocess engineering, biochemistry, Pharmacy, or related pharmaceutical science) is required. Masters and/or PhD level degree is strongly preferred.
• 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.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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