Monitoring Functional Excellence Lead – Associate Director
Novartis
Associate Director – Drug Product Lifecycle Management
Bristol Myers Squibb
full-time
Posted on:
Location Type: Hybrid
Location: Massachusetts, New Jersey, Washington • 🇺🇸 United States
Visit company websiteSalary
💰 $200,230 - $266,894 per year
Job Level
Senior
About the role
- Develop and execute the global strategy for cell therapy manufacturing process changes, ensuring alignment with commercial and CMC objectives.
- Own the technical project portfolio for designated cell therapy products, managing schedules, budgets, and resources.
- Lead cross-functional matrix teams to deliver process transformation, improvement, and cost reduction initiatives.
- Drives alignment across CTTO, analytical, quality, regulatory, operations, development, supply chain, program strategy, third-party manufacturing, and manufacturing sites.
- Implements lifecycle management projects and harmonizes manufacturing processes across multiple sites.
- Lead Manufacturing Success Rate (MSR), Robustness, and Cost Reduction initiatives to ensure reliable drug product supply and continuous commercial process transformation.
- Oversee process validation, technology transfer, process qualification, and comparability strategies.
- Lead continuous improvement projects and change control management to enhance product quality, compliance, and supply reliability.
- Lead and oversee the technical package, including project and process risk assessments, governance presentations, and standalone actions to ensure effective project execution.
- Lead and oversee global change controls, CAPAs, proactive initiatives, and standalone actions to maintain compliance and drive improvement.
- Author and review technical content for regulatory submissions (e.g., PPQ, comparability assessments), annual product quality reviews, and technical reports.
- Manage and mentor a technical team, assigning projects and tasks based on strategic priorities.
- Foster a culture of accountability, inclusion, integrity, and innovation.
- Promote diversity, equity, and inclusion in team composition and project execution.
Requirements
- Bachelor’s degree or higher in Engineering, Life Sciences, Biology, Chemistry, Biochemical/Chemical Engineering, or related technical discipline.
- Advanced degree (M.S./Ph.D.) preferred; equivalent experience considered.
- 14+ years of relevant experience in cell therapy, biologics, or pharmaceutical manufacturing.
- Proven leadership of technical teams and project in a matrixed environment.
- Expertise in cGMP operations, technology transfer, process validation, regulatory compliance, and change management.
- Deep knowledge of Cell Therapy Drug Product Manufacturing and sterile drug product operations.
- Strong understanding of CMC regulatory requirements, DS & DP manufacturing, and analytical testing.
- Excellent strategic thinking, problem-solving, decision-making, and communication skills.
- Familiarity with project management tools and Lean Six Sigma methodologies is a plus.
- Ability to travel up to 20%.
Benefits
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
cell therapy manufacturingprocess validationtechnology transferregulatory compliancechange managementcGMP operationsanalytical testingLean Six Sigmaproject managementbiologics manufacturing
Soft skills
leadershipstrategic thinkingproblem-solvingdecision-makingcommunicationteam managementaccountabilityinclusionintegrityinnovation
