About Tonix*Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease. Tonix markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix's development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix's CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The Company's immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix's infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, which also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. Position OverviewTonix is seeking a Manager of Quality Control effectively overseeing contract organization generation of analytical data for product release, stability and development. This position would be responsible for oversignt, implementation and development of quality control expectations on developing product candidates and commercial operations. This position would also be responsible for analytical development and assay troubleshooting at contract organizations. The manager will support all aspects of this process including product release, stability trending, ICH guidance adherence and support all aspects as required by the internal and contract quality systems. This is a fast-paced, challenging position that offers a competitive compensation and benefits package. This role 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. Essential Duties
- Oversee the inprocess and release product testing and stabilityin 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 the 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
- 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
- Follow all established occupational health and safety procedures, good manufacturing practices (GMP's) and standard operating procedures (SOP's)
- 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
Supervisory Responsibilities
- Recruits, interviews, hires, and trains new team members
- Oversees the daily workflow of the department
- 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
Minimum Qualifications
- Bachelor's degree in Chemistry, Biochemistry, or a closely related field with atleast 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); AND
- At least 8 years of cGMP QC experience in biotechnology/large molecule and small molecule industry; AND
- At least 8 years of experience with QC principles, USP/Ph Eur compendia testing requirements, and various analytical and biochemical testing techniques; AND
- At least 5years of experience in method transfer and qualification/validation activities.
- Ability for travel 20% of the time
- Dedicated team player who can withstand the high demands of a fast-paced environment
- Excellent written and verbal communication skills are essential
- Strong planning and organizational skills
- Comfortable working independently with minimal supervision
- Highly organized, results driven, problem solver, and collaborator
- Demonstrated ability to perform the essential duties of the position with or without accommodation
Recruitment & Staffing AgenciesTonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes.Compensation & BenefitsAnnualized 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.Tonix provides a comprehensive compensation and benefits package which includes:
- 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
- Pet Insurance
- Retirement Savings 401k with company match and annual discretionary stock options
- Generous Paid Time Off, Sick Time, & Paid Holidays
- Career Development and Training
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. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits 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.