Associate Director Manufacturing NPI & Clinical Readiness

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.

The Associate Director of New Product Introduction (NPI) and Clinical Readiness will lead a team to ensuring the successful introduction of new products into existing commercial manufacturing facility with a strong focus on manufacturing readiness, technical transfer, and operational process performance qualification (PPQ) improvements. This role will lead the cross-functional alignment as necessary to transition new therapies from development into full-scale manufacturing while optimizing process robustness and regulatory compliance.

This role will drive manufacturing readiness, ensuring seamless execution from clinical to commercial production, managing technology transfer activities in operations, and implementing continuous improvements driven by the overall NPI team. The role requires working collaboratively with MSAT, Quality, Supply Chain, IT, Manufacturing, and Regulatory teams to ensure smooth product integration and site readiness.

QUALIFICATION REQUIREMENTS (Knowledge, Skills and Abilities):
Education: Bachelor’s or Graduate degree in Engineering, Life Sciences, or related fields.

Experience:10+ years of experience in pharmaceutical/biotech manufacturing, with a focus on new product introduction, tech transfer, and process validation.

Proven experience leading cross-functional teams and managing complex projects in a regulated cGMP environment.

Strong expertise in tech transfer, PPQ execution, and manufacturing readiness.

Experience with cell therapy or biologics manufacturing preferred.

Skills & Abilities:
Deep understanding of cGMPs, process validation, and regulatory requirements.

Strong leadership and project management skills.

Ability to navigate matrix organizations and influence cross-functional teams.

Excellent problem-solving and critical thinking skills.

Strong communication skills, with the ability to engage with leadership and regulatory bodies.

Travel Requirements
☐ Not Applicable
☒ Some travel required for site visits, regulatory interactions, and tech transfer execution.

Licenses/Certifications:    

ROLES AND RESPONSIBILITIES:
1. Manufacturing Readiness & Execution
•    Develop and implement manufacturing readiness plans to ensure smooth integration of new products into commercial manufacturing.
•    Partner with Manufacturing and Quality to identify gaps and execute readiness strategies.
•    Lead risk assessments and mitigation planning to enhance process robustness.
2. Tech Transfer & Scale-Up
•    Own and drive manufacturing systems that support technology transfer strategies from clinical development through PPQ and commercial launch.
•    Actively support site tech transfer teams-during process comparability, process validation, and ensure seamless transition between sites.
•    Collaborate with MSAT and development teams to improve tech transfer methodologies.
3. Process Performance Qualification (PPQ) & Regulatory Alignment
•    Lead team of manufacturing through - PPQ strategy and execution, ensuring alignment with regulatory expectations.
•    Support the delivery of key PPQ milestones, including ensuring operational readiness, employee training, and data collection—with a safety first, quality always mindset.
•    Support process validation lifecycle, ensuring processes meet regulatory and business requirements.
•    Drive post-PPQ improvements and lifecycle management.
4. Cross-Functional Leadership & Stakeholder Engagement
•    Lead manufacturing NPI team and support cross-functional teams to ensure alignment on NPI execution.
•    Serve as a site representative in network-level NPI manufacturing discussions.
•    Communicate progress, risks, and mitigation plans to manufacturing senior leadership and stakeholders.
5. Continuous Improvement & Best Practices
•    Identify and drive process and operational improvements to enhance NPI efficiency.
•    Implement best practices in tech transfer, PPQ execution, and manufacturing readiness.
•    Leverage digital tools and data analytics for process optimization.

The starting compensation for this job is a range from $172,090 to $208,500, plus incentive cash and stock opportunities (based on eligibility). 

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. 
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 our BMS Careers Site.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

BMSCART

GPS_2025

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 a supportive culture, promoting global participation 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 an 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 [email protected]. 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/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.