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Director, Aseptic Operations - Sterile Fill

Director, Aseptic Operations - Sterile Fill

Endo PharmaceuticalsRochester, MI, US
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Director Of Operations

The Director of Operations at the Rochester MI facility leads the establishment, implementation, maintenance and execution of : cleaning, sanitization, and / or sterilization of production equipment and facilities; raw material sampling, dispensing and product formulation; aseptic / sterile primary packaging of liquid, suspension, or lyophilized product in plastic bottles, vials or syringes; inspection, secondary labeling and packaging of the finished product. Work requires excellent teamwork, ability to communicate clearly, and cooperate with other staff members to achieve overall organizational objectives and sustain site's positive performance record associated with Quality Management System (QMS), cGMP and EHS compliance. The individual must have the ability to coordinate work between functions to ensure alignment with overall site Vision, Mission and Execution Strategy.

Scope of Authority (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

Key Accountabilities - key outcomes / deliverables, the major responsibilities, and % of time

Operations

  • 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

  • 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

  • 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 WorkForce 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

  • 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 development opportunities for all staff.
  • Manages special projects as requested / assigned by Executive Team.

    • Qualifications

    Education & Experience

  • Direct parenteral manufacturing / quality experience preferred.
  • Bachelors / Master's degree from an accredited college or university with a major in Science, Packaging Engineering or Business
  • Six-ten years of progressively responsible work-related experience designing, customizing, managing and evaluating manufacturing operations inclusive of programs to support ongoing personnel development.
  • Minimum of 10 years supervisory / leadership experience with specific involvement with Operations, Quality and / or Compliance Management. Emphasis on team building, problem solving and employee development inclusive of succession planning.
  • High level of proficiency in adult education and training, and group presentation.
  • Must be familiar with different approaches to staff and management development using various delivery systems.
  • Skilled in relational databases and ability to use computerized software to support management reporting including word processing, spreadsheets, charts / graphs and presentations.

    • Knowledge

  • Microsoft Office Suite, Quality Management Systems(QMS : Trackwise, LMS, LIMS), Enterprise Resource Planning (ERP) Systems, Calibration Maintenance Management Systems (CMMS)
  • CFR 210, 211, 610, Part 11, and Parenteral Manufacturing Guidance (FDA / EU Annexes)

    • Skills & Abilities

  • Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes oneself available to staff; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.
  • Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
  • Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
  • Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
  • Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
  • Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
  • Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
  • Ethics - Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
  • Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization
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