Senior Specialist, Quality Control

Job Description

Job Description

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 Overview

The Sr. Specialist of Quality Control will oversee contract organization method development in support of product release, process development and stability. This position would be responsible for implementation and development of quality control expectations on investigational products and commercial operations including analytical development and assay troubleshooting. The Sr. Specialist will support all aspects of this process including analytical development, product release, stability trending, ICH guidance adherence and support all aspects as required by the internal and contract quality systems.

Essential Duties

• Oversee the implementation of general laboratory operational systems and testing capabilities, related method development, transfer and qualification activities, investigations, data trending and assay/instrument troubleshooting
• Support the development and implementation of new analytical methods as required to meet quality attributes
• Oversee the in-process and release product testing in support of manufactured drug substance and drug product to ensure the product meets quality attributes performed at contract organizations
• Collaborate with the other Quality and functional area to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate
• Provide support for the appropriate strategic planning for continuous improvement and reporting/escalation of issues and/or risk mitigation activities to ensure a culture of quality and compliance
• Oversee product stability studies aligned with ICH guidelines to support shelf life and product retest assessment
• 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

Necessary Skills and Abilities

• Strong understanding of regulatory testing (USP, EP, ICH) regulations
• Strong understanding method validation requirements to meet regulatory expectations
• Strong understanding of analytical techniques used to assess quality attributes of biological, viral and or small molecule drug substances and products
• Ability to perform statistical trending of development, release and stability data to determine product quality attributes
• Results driven, problem solver, and collaborator
• Ability to Perform ad-hoc work/special projects to support Tonix on various business initiatives and see through to completion with minimal supervision
• Ability to travel 20% of the time

Education and Experience Requirements

• Bachelor's degree in Chemistry, Biochemistry, or a closely related field
• At least 6 years of cGMP QC experience in biotechnology/large molecule and small molecule industry with QC principles, USP/Ph Eur compendia testing requirements, with various analytical and biochemical testing techniques;
• Experience in analytical method development, validation and transfer
• Technical expertise in analytical platforms.
• Scientific technical writing ability for technical reports, SOP or other processes to support regulatory compliance.

Recruitment & Staffing Agencies

Tonix 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 & Benefits

Annualized base salary ranges from $70,000 to $120,000 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, 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.