Sterile Injectables Supervisor

Department: Production

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 Sterile Injectables Supervisor is responsible for the manufacturing of sterile liquids for commercial distribution in accordance with the schedule put forward by production leadership. The position is considered a -working supervisor- position meaning that personnel in this role will train, organize and lead team members to complete daily operation requirements as well operate manufacturing processing equipment (as needed) by following standard operating procedures and batch records in accordance with FDA Current Good Manufacturing Practices. In addition, personnel in this position will employ acceptable aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning. Personnel in this position will serve as SOP and BPR subject matter experts reviewing, closing out, and revising these documents as deemed required by production leadership.

• Review and correction of area specific executed batch records and log books to meet timely closure of the documents.

• Troubleshoots a majority of basic machine issues and reaches out for maintenance support when needed in order to meet production timelines.

• Identifies and implements operational optimizations of the equipment via machine recipe parameter adjustment, including timers, counters and cams.

• Gathers all necessary CoA/CoC and lab results to close out area specific batch records.

• 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 and terminal sterilization.

• 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.

• Serves as area specific SME developing, revising and approving all manner of CGMP framework including protocols, SOP-s, BMR-s, risk assessments and summary reports.

• Provides training to other operators.

• Follows written procedures.

• Clearly and accurately documents activities.

• Performs basic math calculations.

• Submits in-process samples to responsible departments.

• Performs cleaning of rooms, tools and equipment as needed.

• Responsible to ensure that the product meets specification.

• Attain and maintain Aseptic Gown Certification.

• Operate Autoclave to prepare/sterilize supplies as needed.

• Read, understand and review SOP-s and Protocols as required.

  JOB RESPONSIBILITIES:

  Operations Excellence:

  • Serves as area SME of equipment, processes, and documents driving the process.

  • Operate, maintain, assemble & disassemble, clean and set-up applicable production equipment.

  • Review, correction and close out of area specific batch records.

  • Maintain documentation and functional work areas to GMP standards.

  • Communicates effectively to area leadership and all cross functional groups to ensure completion of production demands.

  • 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:

  • Must possess knowledge of the metric weight system.

  • Must be able to adhere to outlined procedures and practices and follow specific instructions.

  • Must possess strong math skills, documentation skills, and organization skills.

  • Must be able to lift up to 40-50 lbs.

  • Must possess good manual dexterity.

  • Must possess basic knowledge of CGMP-s.

  • Must be able to transcribe detailed data accurately according to CGMP and SOP standards.

  • Must be able to work overtime with little or no notice. Must maintain good attendance.

  • 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:

  Associate/Bachelor Degree preferred

  Experience:

  5 - 7 Years- experience in CGMP/Aseptic Operations Background

  Knowledge & Skills:

• FDA/CGMP/Mechanical Aptitude/Process SME

• Working Lead, sets tone for area specific production group

• Flexible, able to work overtime when needed.

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