Manufacturing Associate III - Newark, CA | Biospace
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Manufacturing Associate III

Revance Therapeutics, Inc.

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Location:
Newark, CA
Posted Date:
8/7/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Associate, Manufacturing, Manufacturing/Production,

Job Description


You will be a part of the manufacturing organization and provide hands-on execution of tasks related to the cGMP manufacture of biopharmaceuticals working in bacterial fermentation, purification and/or fill-finish. As a lead you set a positive example for those working in the team.

Essential Functions:

•   Schedule team activities within the manufacturing facility including the coordination of production schedules, calibration and validation.
•   May coordinate schedule with process science teams, analytical testing personnel, microbiological support team, facilities and sanitization groups.
•   Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.) and has the ability to serve as the lead in these activities.
•   Operate in a controlled GMP environment.
•   Ensure compliance with established internal and external control procedures.
•   Assist in the execution of process, equipment and cleaning validation.
•   Responsible for revising and originating production records, standard operating procedures, protocols and reports.
•   Initiate and close out Deviation Report, Change Requests and CAPAs.
•   Train and mentor new manufacturing associates 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.
•   Work with Quality Control, Facilities, Materials Management, Quality Assurance and Validation to complete assignments, and ensure ongoing continuous improvement.

Requirements


Preferred Experience:

•   3+ years experience with pharmaceutical or biotechnology manufacturing processes; or equivalent education, training, and experience.
•   Aseptic technique, cleanroom gowning and extensive knowledge of Good Manufacturing Practices (GMPs).
•   Has proven successful people management experience.
•   Demonstrates ability to interact with senior management.
•   Has proven successful operational management in manufacturing function.
•   Hands-on experience with TFF skids, purification columns, automated filling/capping machine, and Lyophilizer.
•   Good analytical skills to interpret manufacturing data and understand production problems.
•   Experience with process development, transfer, and optimization is a plus.
•   Hands-on experience with aseptic fill finish operation.
•   Experience with execution of validation protocols is a plus.
•   Experience working with potent/toxic agents is a plus.

Preferred Education:

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

Preferred Additional Skills (i.e., Computer):

•   Excellent communications skills and good attention to detail.
•   Ability to work in fast paced, dynamic, team environment.
•   Ability to handle multiple projects at one time.
•   Basic knowledge of MS Office (Word, Excel, Outlook, PowerPoint and Project).
•   Ability to lift 25 pounds and stand for extended periods of time.
•   Flexibility in job responsibilities and scheduling is encouraged to meet business needs.