Qc Manager, Cell-Based Potency Assay

JOB SUMMARY

Revance is setting the new standard for our clients through our disruptive products and for our employees through our industry-leading benefits that promote financial and physical health & well-being for all employees. The anticipated base salary for candidates for this open role is $125,000 to $161,700. The final salary offered to a successful candidate will be dependent upon factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, and geographic location within the United States.

The Manager, QC Cell-based Potency Assay will play a critical role as the subject matter expert (SME) for cell culture operations and establishment of potency assay for Botulinum toxin. Area of responsibilities includes, but not limited to, sample management, overseeing working cell bank and critical reagent programs and coordinating sample testing schedules to meet product release timelines. Additionally, this role will be involved in method transfer and validation as well as working closely within the QC organization to establish laboratory and staff efficiency.

The incumbent will be required to successfully complete a Security Risk Assessment (SRA) to work with select agent or toxin.

ESSENTIAL DUTIES

• Support internal and external audits
• Author and manage technical reports, deviations, lab investigations, CAPA and change control documents.
• Oversee day-to-day operations associate with cell culture maintenance, in-process, release, and stability testing of clinical and commercial products (DS and DP) for cell-based potency. Schedule testing and perform data reviews.
• Provide mentorship and training to junior analysts to ensure technical understanding of methods including troubleshooting of instrumentation. Consistently evaluates departmental structure and talent to meet evolving business needs.
• Support method transfer and validation, including authoring of protocols and reports
• Ensure laboratory is operating in a steady state through oversight of laboratory inventory, reagent and standard qualification, and compliance to the quality management system for continuous operation with minimal disruption.
• Creates, revises, and reviews procedures, work instructions and risk assessments as needed

EDUCATION

Minimum Required:

• Bachelor of Science in Molecular and Cell Biology or related pharmaceutical biotechnology discipline

Preferred:

• Master's Degree

EXPERIENCE

Minimum Required:

• 3+ years managing a Quality Control team at a company focused on biologics drug substance and drug product in a commercial environment
• Experience in Bioassay within cell culture matrix method development and method validation is a plus
• 6 to 8 years of experience in a GMP environment in pharmaceutical or biotechnology industry

COMPETENCIES

Key Competencies:

WORK ENVIRONMENT & PHYSICAL DEMANDS

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."

• Must be able to lift up to 10 pounds at times
• Prolonged periods of sitting at a desk and working on a computer

We are an equal opportunity employer. We are a company where diverse backgrounds, experiences 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.