Tonix Pharmaceuticals · 3 weeks ago
Senior Specialist, QC
North Dartmouth, MA
Full-time
Onsite
Senior Level
6+ years expTonix Pharmaceuticals is a fully integrated biotechnology company focused on commercializing and developing therapeutics to treat and prevent human disease. The Senior Specialist of Quality Control will oversee method development for product release and stability, ensuring compliance with quality control expectations and regulatory standards.
BiopharmaBiotechnologyMedicalPharmaceutical
Responsibilities
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
Qualification
Required
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
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
Benefits
Medical, Dental & Vision Insurance
Basic and Voluntary Life and AD&D Insurance
Short- and Long-Term Disability Insurance
Flexible Spending Accounts
Health Savings Account
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
Company
Tonix Pharmaceuticals
Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).
51-200 employees
H1B Sponsorship
Tonix Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$336.74MKey Investors
Point72Medical CBRN Defense ConsortiumTechnology Partners
2025-12-29Post Ipo Equity· $20M
2025-03-10Grant
2024-06-12Post Ipo Equity· $4M
Leadership Team
Seth Lederman
CEO
Zeil Rosenberg
Executive Vice President, Medical
Recent News
2025-12-29
2025-12-29
Company data provided by crunchbase