30 days old

Manufacturing Associate III

Revance Therapeutics Inc.
Newark, CA 94560
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  • Job Code
    122889125
Category: Manufacturing
Location: Newark, California

Description

Position Summary

The incumbent will be a part of the manufacturing organization and provide hands-on execution of tasks related to the cGMP manufacture of biopharmaceuticals working in aseptic fill-finish. The incumbent will demonstrate the ability to execute critical and complex cGMP tasks and will demonstrate flexibility to support business needs. The incumbent will work with area management to execute and maintain the production schedule.

Essential Duties/Responsibilities
  • Ensure compliance with established internal and external control procedures.
  • Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.) within a controlled GMP environment and serves as the lead in these activities.
  • Demonstrates ability to proficiently operate and troubleshoot Drug Product-related process equipment.
  • Supports the continuous training of Drug Product Manufacturing Staff on procedures, aseptic techniques, equipment and trouble-shooting skills.
  • Review in-process and completed documents for accuracy and to make sure batch records are turned in to area management within specified days of completion.
  • Responsible for revising and originating production records, standard operating procedures, protocols and reports.
  • Initiate and close out Deviation Reports, Change Requests and CAPAs as required per business needs.
  • Work with Quality Control, Facilities, Materials Management, Quality Assurance and Validation to complete assignments.
  • Drives ongoing continuous improvement within the Drug Product Manufacturing Process.


Education

Minimum Required:

High School Diploma or Equivalent.

Preferred:

Bachelor's degree in biological sciences, chemical engineering or related discipline

Experience

Minimum Required:
  • 6 years of experience with pharmaceutical or biotechnology manufacturing processes; or equivalent education, training, and experience.
  • Advanced skills with Aseptic technique, cleanroom gowning and extensive knowledge of Good Manufacturing Practices (GMPs).
  • Advanced skills with aseptic fill finish operation.
  • Advanced experience with automated filling/capping machine, and Lyophilizer.
  • Intermediate experience in analytical skills to interpret manufacturing data and understand production problems.
  • General experience interacting with senior management.


Preferred:
  • Experience with people management.
  • Experience with process development, transfer, and optimization is a plus.
  • Experience with execution of validation protocols is a plus.
  • Experience working with potent/toxic agents is a plus.


Knowledge, Skills and Abilities

Minimum Required:
  • Comprehensive communications skills and good attention to detail.
  • Ability to work in fast paced, dynamic, team environment.
  • Ability to lift 25 pounds and stand for extended periods of time.


Preferred:
  • Flexibility in job responsibilities and scheduling is encouraged to meet business needs.
  • Ability to handle multiple projects at one time.
  • Basic knowledge of MS Office (Word, Excel, Outlook, PowerPoint and Project).




PI122889125
Posted: 2020-08-22 Expires: 2020-09-23

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Manufacturing Associate III

Revance Therapeutics Inc.
Newark, CA 94560

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