Manager, Aseptic Operations

Department: QA Manufacturing

Location: Monroe, NC

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Glenmark is a leading player 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 US generics business. The subsidiary also markets APIs to regulated and semi-regulated countries.

POSITION SUMMARY:

The Manager of Aseptic Manufacturing Operations is responsible for leading a team of production supervisors, team leads, compounding, aseptic, cleaning and packaging and technicians in 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:

• 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 meetings to communicate day-s activities and production needs.

• Communicates effectively with area leadership and cross-functional departments including 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.

• 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.

  JOB RESPONSIBILITIES:

  Operations Excellence:

  • Leads a team of production supervisors, team leads, compounding, aseptic, cleaning and packaging and technicians in 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.

  • 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

  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.

  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

  Education:

  Bachelor Degree Required

  Experience:

  10 - 12 Years- experience in CGMP/Aseptic Operations Background

  Knowledge & Skills:

  FDA/CGMP/Mechanical Aptitude/Process SME

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