Lead Manufacturing Technician

Job Summary:

The Lead Manufacturing Technician will be a part of the manufacturing organization and provide hands-on execution of tasks and technical support related to the cGMP manufacture of biopharmaceuticals working in aseptic fill-finish. The incumbent will work with area management to coordinate and schedule routine activities and to resolve process-related issues.

Reporting to:    Lead Manufacturing Technician

Location:     Newark, CA (5 days/week onsite)

Salary Range:     $37.26 - $51.27

Responsibilities/Essential Duties:

• Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.) while operating in a controlled GMP environment and serves as the lead in these activities.
• Works in compliance with established internal and external control procedures.
• Represent the department in cross-functional meetings, equipment qualifications and provide feedback to area management.
• Provides technical support for any process-related issues or escalations and works with Area Management for resolution.
• Responsible for revising and originating production records, standard operating procedures, protocols and reports; initiates and closes out Deviation Reports, Change Requests and CAPAs on time.
• Drives Drug Product process improvement initiatives including, but not limited to, performing Risk Assessments and the introduction, modification, or qualification of new or existing Drug Product processes.
• Train and mentor new manufacturing staff on procedures, aseptic techniques, equipment and trouble-shooting skills.
• Work with area management to perform initial review of in-process and completed documents for accuracy and to make sure batch records are turned in to area management within specified days of completion.
• Coordinate with Quality Control, Facilities, Materials Management, Quality Assurance, Validation and to execute and complete production-related activities.

Basic Qualifications:

• Bachelor’s degree & 4 years’ directly related experience; OR
• Associate’s degree & 6 years’ directly related experience; OR
• High school diploma / GED & 8 years’ directly related experience
  
  

Preferred Qualifications:

• Bachelor’s degree or above in biological sciences, chemical engineering or related discipline
• 5 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 (GMP).
• Demonstrates ability to interact with senior management.
• Hands-on experience with automated filling/capping machine, and Lyophilizer.
• Good analytical skills to interpret manufacturing data and understand production problems.
• Experience with process development, transfer and optimization.
• Hands-on experience with aseptic fill finish operation.
• Experience with execution of validation protocols.
• Experience working with potent/toxic agents.
• Excellent 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.
• 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).
  
  

Company Summary:

As a commercial-stage biotechnology company focused on innovative aesthetic and therapeutic offerings, Revance is setting the new standard for its clients through disruptive products, and for its employees through industry-leading benefits, which promote financial and physical well-being for all. It’s time to rethink everything you thought an employee experience could be.

What Revance invests in you: 

• Competitive Compensation including base salary and annual target bonus
• Flexible unlimited PTO, summer & winter shutdowns, and 12 weeks parental leave
• Generous healthcare benefits (Company pays up to 90% of premiums for medical benefits), Employer HSA contribution, 401k match, tuition reimbursement, wellness discounts and much more

Note: Revance has agreed to merge with Crown Laboratories.  Upon completion of this merger, benefits are subject to change.

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.” 

We are an equal opportunity employer. We are a company where diverse backgrounds, experience and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual’s race, color, national or ethnic origin, religion, age sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.