Tonix Pharmaceuticals
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Senior Specialist, QC
role at
Tonix Pharmaceuticals
Position Overview The Senior Specialist of Quality Control will oversee contract organization method development in support of product release, process development and stability. The position is responsible for implementing and developing quality control expectations on investigational products and commercial operations, including analytical development and assay troubleshooting. The role will support all aspects of analytical development, product release, stability trending, ICH guidance adherence, and all aspects of 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 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 other Quality and functional areas to ensure patient safety and compliance with FDA and other applicable global health authority requirements.
Provide support for 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, GMPs and SOPs.
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 of 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 the biotechnology/large molecule and small molecule industry with QC principles, USP/Ph Eur compendia testing requirements, and 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, SOPs or other processes to support regulatory compliance.
Compensation & 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, and Employee Assistance Programs.
Pet Insurance.
Retirement Savings 401(k) with company match and annual discretionary stock options.
Generous Paid Time Off, Sick Time, & Paid Holidays.
Career Development and Training.
EEO Statement 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, informational, disability, veteran status, or any other characteristic protected by law.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Industries Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Tonix Pharmaceuticals by 2x.
Get notified about new Senior Quality Assurance Specialist jobs in
Dartmouth, MA .
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Senior Specialist, QC
role at
Tonix Pharmaceuticals
Position Overview The Senior Specialist of Quality Control will oversee contract organization method development in support of product release, process development and stability. The position is responsible for implementing and developing quality control expectations on investigational products and commercial operations, including analytical development and assay troubleshooting. The role will support all aspects of analytical development, product release, stability trending, ICH guidance adherence, and all aspects of 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 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 other Quality and functional areas to ensure patient safety and compliance with FDA and other applicable global health authority requirements.
Provide support for 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, GMPs and SOPs.
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 of 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 the biotechnology/large molecule and small molecule industry with QC principles, USP/Ph Eur compendia testing requirements, and 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, SOPs or other processes to support regulatory compliance.
Compensation & 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, and Employee Assistance Programs.
Pet Insurance.
Retirement Savings 401(k) with company match and annual discretionary stock options.
Generous Paid Time Off, Sick Time, & Paid Holidays.
Career Development and Training.
EEO Statement 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, informational, disability, veteran status, or any other characteristic protected by law.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Industries Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Tonix Pharmaceuticals by 2x.
Get notified about new Senior Quality Assurance Specialist jobs in
Dartmouth, MA .
#J-18808-Ljbffr