Director, Aseptic Operations - Sterile Fill

Job Description Summary

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&L responsibility, etc.

• Span of Control: oversight of five (5) budgetary departments representing seven (7) operational working units:
  1) Sanitation, Drug & Chemical Dispensing, Bulk Manufacturing;
  2) Preparation Services;
  3) Sterile Filling;
  4) Inspection & Packaging, and
  5) Manufacturing Administration
• Operating Budget: $15M;
  Spend/signing authority at $25K

• Operations 20%
  • Directs production in Sanitation, Preparation Services, Drug & Chemical Dispensing, Bulk Manufacturing, Sterile Filling, Inspection & Packaging.
  • Oversees execution of commercial production to meet patient, quality, business, and financial objectives as well as supporting developmental and technical transfer production activities across three shifts.
  • Maintains proper staffing and training levels to meet requirements.
  • Provides management reporting through development and use of department metrics aligned with Site Objectives and Scorecard.
  • Sets priorities to meet internal cycle times and delivery schedules.
  • Assures adequate maintenance of department machinery and supplies.
  • Establishes and drives expectations for production schedules & reducing non-value-added waste while meeting weekly delivery schedule and financial objectives.
  • Participates and develops long-term strategies and risk management programs that increase the compliance, efficiency and effectiveness of operations.
• Compliance 20%
  • Develops and maintains a safe manufacturing environment in accordance with plant/corporate policies and with local, state and federal environmental, health and safety regulations. Participates in safety meetings, investigates accidents, expects proper PPE and industrial hygiene controls, and takes appropriate corrective actions to eliminate hazardous conditions.
  • Promotes a quality and compliance focused culture which embraces RFT (right first time) and CI (continuous improvement).
  • Assures cGMP compliance with regulatory agencies (FDA, EMA, etc.).
  • Performs assessments and risk assessments based on business development and new product/process/technical transfer activities associated with employee operations, GMP Compliance and safety.
  • Lead initiatives for root cause analysis to implement effective corrective actions, reducing the potential for deviations related to human error.
  • Manage audits and inspections by regulators, corporate office and contract customers by escorting and facilitating information sharing, document review and response commitments.
  • Directs change controls related to processes, equipment, documentation and safety practices in accordance with Quality System requirements.
• Supervisory Responsibilities 20%
  • Interviews, hires, and ensures training of employees; plans, assigns, and directs work; appraises performance; rewards and redirects employee's activities; addresses complaints and resolves problems.
  • Develops and trains managers & supervisors for more effective performance in current assignments as well as future leadership roles to meet on-going personnel development and succession planning objectives for continued business continuity.
  • Secures effective training programs or resources thru partnership with the Work Force Development Team to support compliance with CFR, OSHA regulations, and manufacturing execution demands.
  • Assures compliance with procedures, cGMP's regulations, safety, and contract obligations. Reviews documentation produced by management for violations of company policy; recommends disciplinary actions.
  • Number of exempt employees - direct: 6-8; indirect: 15-25
  • Number of Hourly employees - indirect: 100-150
• Leadership 40%
  • Establishes expectations, drives accountability & influences effective team building and team work.
  • Creates an atmosphere of team effort, open communication and inspirational shop floor management.
  • Interacts productively with peers across all site work streams.
  • Leads operations managers, supervisors, and hourly staff.
  • Develops cooperative relationships with contractual bargaining agreement leadership team and colleagues.
  • Meets site objectives in compliance, quality, transformation, employee learning & development, and financial areas.
  • Supports capital planning initiatives to ensure site remains compliant with local, state and federal requirements.
  • Sponsors Operational Excellence Program (OEP) improvements as…