Senior Specialist, QC

Role Summary

The Senior 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.

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

Qualifications

• Required: Bachelor's degree in Chemistry, Biochemistry, or a closely related field
• Required: 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
• Required: Experience in analytical method development, validation and transfer
• Required: Technical expertise in analytical platforms
• Required: Scientific technical writing ability for technical reports, SOP or other processes to support regulatory compliance

Skills

• 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

• Bachelor's degree in Chemistry, Biochemistry, or a closely related field

Additional Requirements

• Travel: Ability to travel 20% of the time