Finished Product Supervisor, QC Analytical

Position Summary

The QC Finished Product Supervisor 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.

The position is part of the Federal Select Agent Program. All individuals who work with these agents will undergo and be required to successfully complete a Security Risk Assessment that is performed by the Federal Bureau of Investigation/Criminal Justice information services.

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).
• 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