Operations Manager

Job Description

Business: Pharma Solutions

Department: Operations

Location: Lexington

Job Overview

The Operations Manager is a key part of the Operations Leadership Team leading a Manufacturing Team of 30 Manufacturing Technicians and Supervisor on a 24/7 operations of 4 cycle shift rotation involved in Formulation and Aseptic Filling of biopharmaceuticals in compliance with Good Manufacturing Practices. The Operations Manager ensures adherence to the production schedule by actively managing operations during the shift in collaboration with the support functions (Maintenance, Engineering, Quality, Planning). She/He maintains a strong culture of Safety and Quality within her/his team and in the manufacturing area in general.

Reporting Structure

Directly reports to Director, Technical Operations

Key Responsibilities

• The Operations Manager embodies Piramal’s success factors and ensures that all activities completed within the manufacturing clean rooms are executed to the highest standards of quality, protecting the safety of the manufacturing team while delivering on manufacturing schedule commitments.
• Leads problem solving working with the cross functional support groups in the identification and resolution of process related issues with a goal to minimize impact on the manufacturing schedule.
• Act as Aseptic Coach by continuously observing and advising on aseptic practices in the manufacturing clean rooms.
• Responsible for ensuring that assigned team(s) are compiling, maintaining, and reviewing all necessary reports, documentation batch records relevant to the manufacturing area including use of relevant software systems and standard operating procedures.
• Monitors daily production activities including: productivity, cost, planning, and business processes
• Ensures manufacturing efficiency and cost reduction through optimum utilization of resources and on-going evaluation and improvement of methods and systems
• Coaches and mentors team members and issues performance reviews
• Ensures team compliance with SOPs, cGMP, FDA and, and other regulatory requirements
• Working with senior leadership, prepares and reviews department budgets and leads cost and efficiency improvement efforts
• Provides reports and analyzes team KPIs and metrics
• Ensure execution of on-boarding activities and training plans
• Drives manufacturing strategy and ensures alignment with overall business strategy
• Implements and oversees operational excellence projects, as assigned.
• Allocates manpower and other resources according to production timelines
• Partners with Quality team(s) to reduce product and/or process failures
• Helps develop and lead efforts regarding continuous improvement of manufacturing performance measures.
• Develops, monitors, and presents department KPIs to ensure performance, improvement, and sustainability against site targets
• Build a team and culture focused on safety, quality, compliance, performance, and employee engagement
  
  

Education Requirements

• Bachelor of Science in Technical/Engineering/Business Operations or related discipline, or equivalent cGMP Pharma and leadership experience
  
  

Experience

• Minimum of 8 years of direct supervisory/management experience in a cGMP pharmaceutical or medical device environment, including aseptic or lyophilization manufacturing
  
  

Competencies

• Demonstrate ability to lead a team and develop others through coaching and facilitation
• Thorough knowledge of cGMP principals and other industry requirements
• Ability to interact with clients, effectively present information and respond to questions
• Demonstrated business acumen
• Analytical and problem solving skills
• Strong organizational skills
• Proficient communicator, both verbal and written.
• Technical writing ability
• Conflict resolution skills