PositionSenior Manager, Packaging Operations
LocationPhiladelphia, Pennsylvania
SummaryThe Senior Manager, Packaging Operations is accountable for creating and maintaining motivation and empowerment of team members, as well as promoting a continuous improvement environment. Additionally, this Associate Director is expected to facilitate technical writing program within the department for but not limited to Batch Record, SOP's, work instructions and investigations. This role will also facilitate all technical training through departmental trainers to Packaging operators, specialists, and supervisors to ensure proper understanding of technical information.
Responsibilities- Achieve the agreed manufacturing schedule, developed in collaboration with Supply Chain and the Packaging Scheduler
- Facilitate Packaging department staffing meetings, generating action plans impacting Packaging departments KPI's. Presents departmental metrics and action plans in management staff meetings.
- Coordinate with other departments (Manufacturing, QA/QC, Compliance, Validation, Product/Technical Development, Regulatory, HR, etc.), relevant regulatory agencies and outside contractors to resolve conflicts, potential problems, and ensure work orders and projects are successfully completed
- Actively coaches all team members promoting continuous improvement and overall team development and cross-training, including the Supervisory level.
- Adhere to cGMP guidelines as well as the CFR.
- Maintain consistent and effective communication with Supervisors, Packaging support staff, and leadership.
- Provide continuous feedback and development opportunities relating to Supervisors and key personnel.
- Continuous analysis of current Packaging processes and procedures, proposals for improvements, implementation, and follow-through on agreed upon changes.
- Follow all documentation procedures assuring that paperwork is in accordance with all company and regulatory standards.
- Responsible for keeping work area neat and orderly along with observing all safety procedures.
- Continuous development, analysis and utilization of established departmental performance data programs to achieve departmental goals. Including future needs and capabilities.
- Understand implications of departmental downtime and inefficient processing.
- Ability to coordinate, contribute to and work within a cross-functional team.
- Contribute to Packaging planning and budgeting
- Uphold Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.
- Works effectively under deadlines.
- Perform other tasks as required.
Experience, Education, and Skills Required- Bachelors degree in an engineering, mathematical, or life sciences discipline
- 5+ years' experience in GMP Packaging environment; knowledge of oral solid dose manufacturing highly preferred
- 3+ years of formal people management experience
- Continuous Improvement and/or Lean Six Sigma experience
- Technical writing skills (i.e. Change Controls, Investigations or Protocols)
- Deviation management, investigation writing and CAPA development
- Product tech transfer and validation experience
- Ability to perform mathematical calculations.
- Excellent interpersonal written and oral communication skills
- Proficient in Microsoft Office and general technical aptitude; working experience with ERP systems
- Strong analytical and problem-solving experience.
- Proven ability to motivate teams and manage conflict.
