Job Summary:
The Manufacturing Technician II 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.
Reporting to: Sr. Manager, Manufacturing
Location: Newark, CA (5 days/week onsite)
Salary Range: $30.69 - $40.50 per hour
Responsibilities/Essential Duties:
- Performs routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.), and can serve as the lead in these activities.
- Operates in a controlled GMP environment.
- Ensures compliance with established internal and external control procedures.
- Demonstrates operational proficiency in Drug Product-related process equipment.
- Assists in the execution of process, equipment and cleaning validation.
- Assists with support tasks within Drug Substance Manufacturing, as business needs permit.
- Responsible for revising and originating production records, standard operating procedures, protocols and reports.
- Initiates and supports the closure of Deviation Reports.
- Supports the closure of CAPA and CR Tasks as required per business needs.
- Trains and mentors new manufacturing associates on procedures, aseptic techniques, equipment and trouble-shooting skills.
- Reviews in-process and completed documents for accuracy, and to make sure batch records are turned in to area management within specified days of completion.
- Works with Quality Control, Facilities, Materials Management, Quality Assurance and Validation to complete assignments.
- Supports the ongoing continuous improvement within the Drug Manufacturing Process.
- May 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.
Basic Qualifications:
- High school diploma / GED or equivalent.
- 3+ years’ experience with pharmaceutical or biotechnology manufacturing processes; or equivalent education, training and experience.
Preferred Qualifications:
- Bachelor’s degree in biological sciences, chemical engineering or related discipline.
- Hands-on skills with aseptic technique, cleanroom gowning, and extensive knowledge of Good Manufacturing Practices (GMPs).
- Hands-on skills with aseptic fill finish operation.
- Hands-on experience with automated filling/capping machine and Lyophilizer.
- Experience with process development, transfer and optimization.
- Experience with execution of validation protocols.
- Experience working with potent/toxic agents.
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
- 15 days’ PTO per year (on prorated basis), 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.
