Quality Management Manager
3 weeks ago
Tonix Pharmaceuticals is seeking a highly skilled Quality Management 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 on developing product candidates and commercial operations.
The ideal candidate will have a strong background in quality control, with experience in overseeing contract organization generation of analytical data. They will be responsible for analytical development and assay troubleshooting at contract organizations, as well as supporting all aspects of product release, stability trending, and ICH guidance adherence.
This is an exempt (salaried) position that will report directly to the director of QC and be based at the Tonix ADC North Dartmouth, MA location in a hybrid capacity. The successful candidate will have a strong understanding of quality control principles, USP/Ph Eur compendia testing requirements, and various analytical and biochemical testing techniques.
Key Responsibilities:
- Oversee the in-process and release product testing and stability in support of manufactured drug substance and drug product to ensure the product meets quality attributes performed at contract organizations
- Oversee the implementation of general laboratory operational systems and testing capabilities, related method transfer and qualification activities, investigations, and assay/instrument troubleshooting
- Support the development and implementation of new analytical methods as required to meet quality attributes
- Work with other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate
- Provide support for the appropriate QC strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities and to ensure a culture of quality and compliance
- Perform statistical trending of stability data to determine product shelf life
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
- Perform ad-hoc work/special projects to support Tonix on various business initiatives
- Provides constructive and timely performance evaluations
- If necessary, handles discipline and termination of employees in accordance with company policy
- Contributes to performance and compensation decisions such as: merit raises, bonuses, and promotions
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 in which the required experience was gained (such as Quality Control Chemist, Quality Control Team Leader)
- 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
- Ability for travel 20% of the time
- Strong planning and organizational skills
- Comfortable working independently with minimal supervision
- Demonstrated ability to perform the essential duties of the position with or without accommodation
Benefits:
- Annualized base salary ranges from $90,000 to $150,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit
- Medical, Dental & 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
- Retirement Savings 401k with company match and annual discretionary stock options
- Generous Paid Time Off, Sick Time, & Paid Holidays
- Career Development and Training
Equal Employment Opportunity:
Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, disability, veterans status, or any other characteristic protected by law.
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