WuXi AppTec

Production Manager

US-CA-San Diego
Job ID
2017-3127

Overview

Responsible for supervising the execution of chemical processes for the preparation of raw materials, starting materials, intermediates, and API in the Kilo-Lab (Process Room suites) and Pilot Plant in compliance with cGMP regulations (as required). This may include acting as lead operator and/or technical supervisor for a given process. Also responsible for keeping the Kilo Lab and Pilot Plant equipment and suites functional and compliant, as well as coordinating with Materials Management as needed to ensure proper inventory is available for production campaigns.

Responsibilities

  • Supervises execution of chemical processes in the Kilo Lab and Pilot Plant suites. May participate in execution of production campaigns depending on project load and available staff to support.
  • Provides technical and trouble-shooting support for Kilo Lab and Pilot Plant processes.
  • Responsible for setting the production schedule in the Kilo Lab and Pilot Plant, as well as determining staff and equipment resources.
  • Responsible for preparation of Master Batch Records (for Kilo Lab and Pilot Plant production) and Standard Operating Procedures (SOPs), as pertaining to Production Operations.
  • Interacts with Facilities, Analytical Chemistry/Quality Control, Process Research & Development, EH&S, and Quality Assurance groups in an effective manner.
  • Works with Process Research & Development staff to develop safe, efficient, and easily scalable chemical processes.
  • Coordinates use tests of various materials before and during production campaigns (as needed).
  • Works with Facilities to schedule repairs and updates (as needed) to the Kilo Lab and Pilot Plant equipment and suites. Responsible for keeping the Kilo Lab and Pilot Plant equipment and suites functional and ready for production campaigns (as needed).
  • Works with equipment/material vendors to keep up with equipment repairs/new equipment/equipment information.
  • Responsible for client interactions as it pertains to production updates and the production schedule. Also, responsible for client interaction during audits.
  • Manages inventory for consumables and equipment as needed, as well as management of raw material and starting material inventory for chemical processing in the Kilo Lab and Pilot Plant suites.
  • Evaluates current procedures and equipment for continuous improvement.
  • Training of Operations personnel, including Operators and Leads, (as required) to be competent in cGMP and EH&S procedures, as well as the chemical processes to be carried out per the specific batch records.
  • Maintains production schedule to meet customer and business goals.
  • Responsible for cGMP compliance of the Kilo Lab and Pilot Plant equipment and suites, as well as the corresponding production processes and products.
  • Responsible for initial qualification of Kilo Lab/Pilot Plant (as required) as well as maintaining the qualification status through periodic re-qualifications (as required). This includes new equipment for use in either area (as applicable).

Qualifications

Technical Skills / Knowledge: 

  • Demonstrated capability in organic chemical process development, scale-up, Pilot Plant processing operations, and cGMP operations.
  • Experience managing production desired.
  • Must be able to use and maintain large-scale chemical processing equipment (reactors, filters, ovens, mills, etc.).
  • Must be able to collate and present results in various forms, such as monthly reports, technical reports, and oral presentations.

Independence/ Accountability: 

  • Supervisory responsibilities for chemical processes and/or Operators/Operations Leads.

 Problem Solving: 

  • Responsible for providing technical and trouble-shooting support to Kilo Lab and Pilot Plant processing.

 Leadership Activities: 

  • Supervises execution of chemical processes in the Kilo Lab and Pilot Plant suites and supervises/trains Operators/Operations Leads (as needed).
  • Manages the inventory for large scale chemical processing (consumables, equipment, materials, etc.).
  • Responsible for keeping the Kilo Lab and Pilot Plant functional and compliant.

 Communication Skills: 

  • Effective communication (both oral and written) required to interact with Facilities, Analytical Chemistry/Quality Control, Process Research & Development, EH&S, and Quality Assurance to accomplish goals.

 Customary Education and Experience: 

  • Bachelor's of Science degree in Chemistry/Chemical Engineering or a related discipline
  • 10-15 years of relevant experience. 
  • Demonstrated understanding of cGMP manufacturing for APIs.

Physical requirements

  • Must be able to lift a minimum of 50 pounds and be able to bend, reach, stretch, climb ladders, and work in tight spaces. 
  • Must be able to stand for long periods of time. 
  • Must be medically fit to wear a respirator and be comfortable working with, and around hazardous materials under strict safety protocols.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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