Associate Director Manufacturing NPI & Clinical Readiness
Associate Director Manufacturing NPI & Clinical Readiness
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$ 172090 - 208500
1 Vacancy
Job Description
Working with Us
Challenging. Meaningful. Lifechanging. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside highachieving 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: Associate Director of New Product Introduction (NPI) is responsible for ensuring the successful introduction of new products into commercial manufacturing with a strong focus on manufacturing readiness technical transfer and process performance qualification (PPQ) improvements. This role will lead the crossfunctional alignment necessary to transition new therapies from development into fullscale manufacturing while optimizing process robustness and regulatory compliance.
The NPI Lead will drive manufacturing readiness ensuring seamless execution from clinical to commercial production managing technology transfer activities and implementing continuous improvements to PPQ strategies. 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:Bachelors 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 crossfunctional 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 crossfunctional teams.
Excellent problemsolving 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 & ScaleUp
Own and drive technology transfer strategies from clinical development through PPQ and commercial launch.
Oversee 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 PPQ strategy and execution ensuring alignment with regulatory expectations.
Define and oversee key PPQ milestones including process validation data collection and readiness reviews.
Support process validation lifecycle ensuring processes meet regulatory and business requirements.
Drive postPPQ improvements and lifecycle management.
4. CrossFunctional Leadership & Stakeholder Engagement
Lead crossfunctional teams (MSAT Quality Manufacturing Supply Chain) to ensure alignment on NPI execution.
Serve as a site representative in networklevel NPI discussions.
Communicate progress risks and mitigation plans to senior leadership and stakeholders.
5. Continuous Improvement & Best Practices
Identify and drive process 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 $172090 to $208500 plus incentive cash and stockopportunities (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: Medicalpharmacy dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).Financial wellbeing resources and a 401(K). Financial protection benefits such as short and longterm disability life insurance supplementalhealth insurance business travel protection and survivor support. Worklife programs include paid national holidays and optional holidaysGlobal Shutdown days between Christmas and New Years 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 liketuition reimbursement and a recognition program.
BMSCART
GPS2025
If you come across a role that intrigues you but doesnt 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 Lifechanging 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.
Onsite Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Siteessential roles require 100% of shifts onsite at your assigned facility. Sitebydesign 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 fieldbased and remotebydesign 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 . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 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: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Director
Employment Type
Full-Time
