Engineer, Manufacturing, Science and Technology (MSAT Engineer)

Company: Tonix Pharmaceuticals
Location: North Dartmouth
Posted on: May 7, 2022

Job Description:

About Tonix*
Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates. Tonix's immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit www.Tonixpharma.com for specifics on the pipeline.
*All of Tonix's product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview
Based on the expansion of its R&D platform and clinical pipeline, Tonix is looking for an Engineer, MSAT to supplement its internal and external teams. The MSAT Engineer will lead technology transfer and support of internal and external manufacturing, as well as contribute to overall technical development. This position will be located at the Tonix Advanced Development Center (ADC) facility in North Dartmouth, MA.
The ideal candidate will be a highly motivated individual with experience in viral products and biologics working in an entrepreneurial environment with broad responsibilities and opportunities.
This is a fast-paced challenging position offering a competitive compensation and benefits package. The position will report directly to the MSAT Manager.
Essential Duties
Lead technical transfer projects for establishing robust and compliant manufacturing processes and associated control strategy
Own and maintain the knowledge and history of manufacturing processes throughout the product lifecycle
Author, review, and approve technical documents such as batch records, sampling plans, SOPs, risk assessments, study protocols, technical reports, and sections for regulatory submissions
Provide first line technical support to manufacturing on the floor in compliance with relevant instructions and quality requirements
Lead process characterization, scale up, process optimization, and process validation
Use scientifically sound rational and statistical tools for data analysis and trending
Contribute to enhancing process understanding and identifying key sources of variability and root causes of product and process failures
Support change review and implementation, risk assessments, quality investigations, impact assessment, and CAPAs in cross-functional teams
Participate in the definition and selection of equipment by providing input to User Requirement Specifications (URS) and creating associated procedures
Support process equipment FAT, SAT, and on-site qualification activities
Plan and organize training for manufacturing personnel
Deliver robust, scalable, and cost-effective manufacturing processes for viral vaccine and biologics drug substance and drug product that meet or exceed the target product profile
Provide hands-on contribution in the Process Development lab during process scale up
Prepare technical reports, publications, and oral presentations
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 as necessary to support Tonix on various business initiatives
Leadership
Accountable for on-time project completion and achievement of compliance goals
Represent the CMC Development function in project team meetings
Minimum Qualifications
Bachelor's Degree in Biochemistry, Chemical Engineering, Biotechnology, or related scientific discipline with three (3) years of experience in biotechnology industry
Biopharmaceutical development and manufacturing experience specifically in viral vaccines and viral-based products required; monoclonal antibodies development is an asset
Broad experience with upstream and purification technologies for viral products, drug substance formulation, and fill/finish
Experience with statistical analysis
Experience with cGMP manufacturing and regulatory submissions
Ability to identify and resolve critical issues
Available for minimal travel
Dedicated team player who is able to 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
Tonix offers salary commensurate with experience and an excellent benefits package.

Keywords: Tonix Pharmaceuticals, New Bedford , Engineer, Manufacturing, Science and Technology (MSAT Engineer), IT / Software / Systems , North Dartmouth, Massachusetts