Quality Control Manager

2 weeks ago

North Dartmouth, United States Tonix Pharmaceuticals Full time
About Tonix Pharmaceuticals

Tonix Pharmaceuticals is a biopharmaceutical company focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. Our product portfolio includes Zembrace SymTouch and Tosymra, which are indicated for the treatment of acute migraine with or without aura in adults. We are committed to advancing innovative treatments for CNS, rare disease, immunology, and infectious disease conditions.

Job Overview

We are seeking a highly experienced Quality Control Manager to oversee the generation of analytical data for product release, stability, and development. This role will be responsible for implementing and developing quality control expectations for developing product candidates and commercial operations. The successful candidate will have a strong background in QC principles, USP/Ph Eur compendia testing requirements, and various analytical and biochemical testing techniques.

Key Responsibilities
  • Oversee in-process and release product testing and stability in support of manufactured drug substance and drug product to ensure quality attributes are met.
  • Implement general laboratory operational systems and testing capabilities, including method transfer and qualification activities, investigations, and assay/instrument troubleshooting.
  • Support the development and implementation of new analytical methods to meet quality attributes.
  • Collaborate with other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements.
  • Provide strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities.
  • Oversee product stability studies aligned with ICH guidelines to support shelf life and product retest assessment.
  • Perform statistical trending of stability data to determine product shelf life.
Requirements
  • Bachelor's degree in Chemistry, Biochemistry, or a closely related field with at least eight (8) years of experience in the job offered or any related position.
  • At least 8 years of cGMP QC experience in biotechnology/large molecule and small molecule industry.
  • At least 8 years of experience with QC principles, USP/Ph Eur compendia testing requirements, and various analytical and biochemical testing techniques.
  • At least 5 years of experience in method transfer and qualification/validation activities.
What We Offer

Tonix Pharmaceuticals provides a comprehensive compensation and benefits package, including medical, dental, and vision insurance, basic and voluntary life and AD&D insurance, short- and long-term disability insurance, flexible spending accounts, health savings account, and employee assistance programs. We also offer pet insurance, retirement savings 401k with company match, and annual discretionary stock options.

We are an equal employment opportunity employer and comply with applicable state and local laws governing nondiscrimination in employment. We prohibit any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, veteran status, or any other characteristic protected by law.

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