Manager , Aseptic Operations

Career Opportunities with Glenmark Pharmaceuticals Inc.

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Glenmark is a leader in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity) with eight molecules in various stages of clinical development. The company has a significant presence in branded generics markets across emerging economies including India. Its subsidiary, Glenmark Generics Limited has a fast growing and robust U.S. generics business. The subsidiary also markets APIs to regulated and semi-regulated countries.

Glenmark employs nearly 10,000 people in over 80 countries and with its twelve manufacturing facilities in four countries, five R&D centers and Front-ends in US, EU, India, Brazil and other markets worldwide, Glenmark is well placed on the road of growth and is exceedingly well prepared to take the completion head-on.

The Aseptic Manufacturing Manager is responsible for leading a team of production supervisors, team leads and technicians. The position specifically owns solution compounding, equipment cleaning, equipment/commodity preparation, equipment/commodity sterilization, aseptic filling, cleaning of classified area and the manufacturing of sterile liquids for development and commercial distribution. This role is a key liaison between site Senior Leadership and the Floor ensuring all business challenges and expectations are communicated, understood and met by the production team.

Personnel in this position operate in broad multifaceted capacity and are responsible for understanding the full CGMP framework established at the site including product development approach, contamination control strategy, media fill program, equipment train, technician qualification and OJT program.

Additional Responsibilities include:

• Expert in aseptic technique and aseptic process Subject Matter Expert (SME).
• Interfaces with the FDA during site audits.
• Evaluates market demand and makes Cap Ex recommendation supporting the process from vendor selection through commissioning.
• Developing, revising and approving all manner of CGMP framework including protocols, SOP’s, BMR’s, risk assessments and summary reports.
• Identifies and implements operational optimizations of the equipment via machine recipe parameter adjustment, including timers, counters and cams.
• Leads daily tier meetings to communicate day’s activities and production needs.
• Communicates effectively with area leadership and cross-functional departments including site leadership, maintenance, QC microbiology, QC chemistry and IPQA to align production needs and ensure timely completion of production schedule.
• Identifies deviations in real time handling write up of the issue and investigation in the QMS, taking guidance from IPQA, QEM and production leadership.
• Has mastery of all aseptic processing concepts and steps including aseptic cleaning, equipment preparation for sterilization, product pathway assembly, sterile filtration, aseptic filling, terminal sterilization, inspection and packaging.
• Maintains production environment in an audit ready state at all times.
• Possesses competitive, detailed oriented production mentality and is not satisfied by anything less than perfection.
• Thinks creatively within the bounds of CGMP framework to overcome challenges and brings viable solutions to the table.
• Documents batch statistics within SAP.
• URS creation.
• Supports Costing Evaluations.
• May provide oversight for other production areas during leadership absences.

• The Aseptic Manufacturing…