Senior Manager, Parenteral Operations (Nights)
Position Overview:
- Primary night leadership point of contact for Parenteral (PAR) areas (formulation, aseptic filling, visual inspection).
- During project phase: support staffing, training, leadership, asset delivery, process development, operations readiness, start-up, and validation.
- After turnover: support annual production goals; lead safety, quality, operational excellence, compliance, and continuous improvement.
- Supervision: line supervision of supervisor(s) with dotted-line oversight of other parenteral supervisors.
Key Objectives / Deliverables:
Integrity
- Lead with Safety first/Quality Always; encourage βStop Work Authority.β
- Lead deviation and corrective action discussions with cross-functional teams (Engineering, Maintenance, TS/MS, Quality, HSE).
- Present investigations/procedures to regulatory agencies; act as SME for inspections/tours.
Excellence
- Ensure shift-to-shift operational consistency (shop floor engagement, Gemba walks, practice vs. procedure).
- Maintain and communicate performance metrics; drive continuous improvement (CI, RCA, FMEA, OSSCE).
- Understand and influence manufacturing control strategy.
Respect for People
- Support site leadership; deliver operational procedures/controls for Parenteral manufacturing.
- Lead ~5β20 employees; set objectives aligned to business plan (production volumes, finances, safety, quality, stewardship, people).
- Secondary contact for Production Planning, HR, Quality Assurance, Engineering, Environmental/Safety.
Requirements:
- Bachelorβs degree in STEM or pharmaceutical field.
- 2+ years in pharmaceutical industry.
- Prior management/leadership with cross-functional collaboration.
- Understanding of regulatory requirements (FDA, EMEA, DEKRA, and/or OSHA).
- US work authorization required; no visa sponsorship.
Preferred (Not Required):
- 3+ years manufacturing/operations with 2+ years supervisory role; cGMP/FDA guidance; aseptic filling/single-use/isolator tech; inspection (automated/manual); automated equipment; SOP/work instruction/training creation; design/startup; qualification/validation; MES/electronic batch release; ASRS/AGVs; lean/six sigma; Trackwise/Veeva/QualityDocs/Kneat.
Work/Travel:
- Safety PPE required; 40 hours/week with overtime/flexibility.
- Frequent domestic travel; possible international travel (~20%/year).
Compensation & Benefits (as stated):
- Anticipated wage: $99,000β$145,200.
- Eligible for company bonus and comprehensive benefits (including 401(k), healthcare, life insurance, and time off).