Manager , Aseptic Operations

Glenmark Pharmaceuticals; Monroe (NC); On-site; USD 120,000 - 170,000; Full time

Job summary

Glenmark Pharmaceuticals in the United States seeks an Aseptic Manufacturing Manager to lead production supervisors and technicians in aseptic filling, solution compounding and equipment preparation for sterile liquids used in development and commercial distribution.

The role requires expert aseptic technique, CGMP knowledge, and coordination with site leadership to meet production schedules, quality standards, and regulatory expectations.

Qualifications

• Bachelor degree required.
• 5–8 years CGMP/aseptic operations experience.
• Knowledge of FDA CGMP and aseptic processing.

Responsibilities

• Lead a team of production supervisors, team leads and technicians.
• Act as liaison between site senior leadership and the floor.
• Review, correct and close out area-specific batch records within expected release timeframe.
• Develop, revise and approve CGMP protocols, SOPs, BMRs and risk assessments.
• Identify deviations in real time and document investigations in the QMS.
• Maintain auditable production environments and ensure readiness for audits.

Skills

Aseptic technique

Team leadership

CGMP knowledge

FDA liaison

Education

Bachelor's degree

Tools

QMS

Job description

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.

Position Summary

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 CapEx 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.
• Leads Risk Assessment (FMEA, HACCP).
• Supports Costing Evaluations.
• May provide oversight for other production areas during leadership absences.

Overall Job Responsibilities

Operations Excellence

• 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.
• Serves as Liaison between site Senior Leadership and the Floor.
• Review, correction and close out of area specific batch records with-in expected release timeframe.
• Maintain documentation and functional work areas to CGMP standards.
• Communicates effectively to area leadership and all cross functional groups to ensure completion of production demands.
• Assesses situation and provides accurate recommendations to overcome challenges, reaching out for appropriate cross-functional support when needed.

Innovations

Responsible for maintaining the company’s high standards of quality, to meet the day-to-day scheduling needs and have the ability to accomplish the departmental goals.

Stakeholder

Consistently operates in an ethical and safe manner; compliant with procedures and policies; builds trust; tells the truth; initiates transparency into problems; communicates issues openly. Builds strong, diverse teams; attracts and retains good people; develops and makes people better; empowers others; flawless execution in order to support all the multiple technology transfer running parallel. A leader that is a change agent, servant leader and continuous improvement champion.

Quality/Output

Continue to drive production and think outside the box to maximize output and try to balance personal life with continue changes on daily tasks requirements. Maintains area in an audit ready state.

Ownership

Ownership of the team, process and the products being manufactured. Doing it correctly the first time with pride and quality. Focus on working with your team members on ways to succeed. Pro-active leader and good communicator.

Education

Bachelor Degree Required

Experience

5 – 8 Years experience in CGMP/Aseptic Operations Background

Knowledge & Skills

FDA/CGMP/Mechanical Aptitude/Aseptic Process SME Servant Leader, Mentor, High Emotional IQ