Licensed Therapist – LCSW, LICSW, LMHC, LMFT – Child or Adult
LifeStance Health
Director, Cell Therapy Drug Product Operations – Risk Management
Bristol Myers Squibb
full-time
Posted on:
Location Type: Hybrid
Location: Massachusetts, New Jersey, Washington • 🇺🇸 United States
Visit company websiteSalary
💰 $190,060 - $253,339 per year
Job Level
Lead
About the role
- Deliver improvements in commercial cell therapy product supply reliability by leading risk assessments, prioritizing risk mitigations, and managing the resulting project portfolio.
- Assess risks/vulnerabilities which impact our ability to reliably supply product on-time and in-spec to patients, with scope encompassing Suppliers, Process, and Analytical.
- Create a holistic Risk Register capturing the landscape of risks and mitigation projects, ensuring alignment with Business Continuity Management and Quality Risk Management.
- Prioritize a selection of risk mitigation projects and identify opportunities to accelerate.
- Partner with matrix team leads to build project schedules, charters, budgets, and resourcing plans.
- Identify areas for deeper dive risk assessment and systems/processes which are targets for improvement; develop plans to address.
- Foster a culture of accountability, inclusion, integrity, and innovation.
Requirements
- B.S., M.S., or Ph.D. in Chemical Engineering, Biochemical Engineering, Biochemistry, or related discipline.
- 15+ years (B.S./M.S.) or 12+ years (Ph.D.) of experience in biologics or cell therapy process development, analytical development, tech transfer, and/or GMP manufacturing support.
- Strong understanding of CMC regulatory requirements, DS & DP manufacturing, and analytical testing.
- Excellent strategic thinking, problem-solving, decision-making, and communication skills.
- Strong knowledge of ICH guidelines, control strategies, and validation lifecycle frameworks.
- Ability to effectively utilize project management and Lean Six Sigma tools is a plus.
- Excellent interpersonal, collaborative, team building, and communication skills.
- Ability to influence senior stakeholders and align cross-functional teams on complex technical and strategic issues.
- Approximately 10-20% travel.
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
risk assessmentrisk mitigationproject managementLean Six Sigmabiologics process developmentcell therapy process developmentanalytical developmentGMP manufacturing supportCMC regulatory requirementsanalytical testing
Soft skills
strategic thinkingproblem-solvingdecision-makingcommunicationinterpersonal skillscollaborationteam buildinginfluenceaccountabilityinnovation
