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Supervisor, Laboratory Operations

Company: Revance
Location: Newark
Posted on: June 8, 2021

Job Description:

Job Summary

The Supervisor, Laboratory Operations will be responsible for the daily management of testing for release and stability of drug substance and drug product including in-process testing as well as performing testing and data review. The individual will support laboratory personnel in the training and mentorship to ensure laboratory efficiencies. Management of laboratory investigations and deviations, including technical writing to identify root cause and corrective actions. The individual will work closely within the QC organization to develop and implement programs to improve laboratory and staff efficiency including management of reagents and resources.

The incumbent will be required to successfully complete a Security Risk Assessment (SRA) via the CDC.

Essential Duties/Responsibilities

  • Will supervise and guide laboratory staff to perform release and stability testing of finished product (drug substance, drug product, novel excipients, and in-process testing).
  • Manage the inventory of laboratory materials and equipment to ensuring laboratory operations are functional and testing is not interupted.
  • Manage the inventory of reagents including critical reagents and reference standards to ensure laboratory operations are maintained with no interuption to testing.
  • Perform product and stability testing, as needed, to support QC turn around times
  • Manage and author the investigation of OOS and aberrant results in product and raw material testing.
  • Manages and authors deviations to investigate root cause, impact and corrective and preventative actions.
  • Provide mentorship and training to junior analysts to ensure technical understanding of methods including troubleshooting instrumentation.
  • Ensure laboratory compliance to cGMPs and other relevant regulatory requirements
  • Development and implement programs to maximize laboratory and staff efficiencies

Education

Minimum Required:

BS in Biochemistry, Chemistry or related Sciences

Experience

Minimum Required:

5+ years in a GMP environment (pharmaceutical or biotechnology industry) with at least 2 of those years in a QC senior analyst role supporting raw material program

Knowledge, Skills and Abilities

Minimum Required:

  • Experience working with biological products in a GMP environment
  • Proven strong interpersonal, organization and problem-solving skills
  • Solid knowledge and understanding of US and international (e.g. EU, ICH, GXP) regulations and guidance applicable to drug substance and drug products
  • Effective verbal and written communications skills, detail-orientated with the ability to work effectively in a fast paced, multi-disciplinary team environment
  • Knowledge of analytical, micro and protein methods is strongly preferred.

Preferred:

  • Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines
  • Experience with preparing regulatory documentation and inspection management

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."

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.

Keywords: Revance, Newark , Supervisor, Laboratory Operations, Other , Newark, California

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