Responsibilities:
- Act as SME in data analytics; partner with Manufacturing/Technical to define, prioritize, document business needs, and deliver data analytics/data science solutions (key conduit between business and BI&T).
- Build dashboards/visualizations; perform ad-hoc data analysis for operational/business decisions.
- Provide technical direction to site teams to improve capacity, quality, cost, and root cause.
- Establish and maintain service level expectations across functions and site systems.
- Support automation/data intake assessment and backlog; ensure alignment with site objectives and senior leadership direction.
- Deliver network improvements (recipe updates, manufacturing data analysis, MES product impact assessments).
- Develop/configure digital solutions (e.g., electronic batch records, process automation) across the solution lifecycle.
- Support lifecycle management, incident/quality investigations, CPV/process monitoring, automated system lifecycle/improvements, and cross-functional interfacing.
- Lead QMS deliverables (SOPs/work practices/training/Change Controls/Actions/CAPAs/technical reports) and drive change management/process improvement.
Qualifications & Required/Preferred Skills:
- Leadership/mentoring; critical reasoning/decision-making; strong organization/time management; independent and cross-functional teamwork.
- Strong written/verbal communication; advanced MS Office; Tableau/Power BI reporting.
- cGMP and multinational biopharmaceutical regulations; cell therapy experience preferred.
- Preferred: ERP/PCS/MES understanding; EBR/RBE and MES recipe lifecycle; HP ALM/EDMS/change systems; CAR-T/biopharma manufacturing & QC; cell culture/cryopreservation/aseptic processing; manufacturing boundary systems.
- Preferred: SQL and Python (or R) data science packages.
- Ability to travel 10%–15%.
Minimum Requirements:
- Bachelor’s degree (Engineering, Biological/Life Sciences, Chemistry, Biochemistry, or related) or equivalent.
- 6+ years manufacturing support/engineering (biotech/pharma).
- 2+ years leadership/supervisory experience preferred.
Compensation/Benefits (as stated):
- Summit West (NJ, US): $106,810–$129,430; additional incentive opportunities may be available.
- Health coverage; wellbeing programs; 401(k), disability, life insurance and other listed protection benefits; Paid Time Off (flexible time off or vacation/holidays depending on location).