Biotech Quality Assurance Director
1 week ago
Resilience Biotechnologies Inc. (RESILIENCE) is a pioneering biomanufacturing company that's revolutionizing the way medicine is produced.
We're committed to creating a sustainable network of high-tech, end-to-end manufacturing solutions to withstand disruptive events, serve scientific discovery, and reach those in need.
The ideal candidate for this role will be accountable for the overall management of QC Chemistry and QC Raw Materials operations at the site in the execution and completion of sample testing using both internal and external contract laboratories.
This includes supporting incoming raw material and component disposition, in-process and final product testing, RBI site utilities, equipment, and environmental controls, validation sample testing, and client stability project requirements.
The successful candidate will ensure all operations are conducted in compliance with cGMP regulations, relevant compendial requirements, company policies, standards, and procedures, and safety standards.
The Biotech Quality Assurance Director will lead a team of skilled analysts and personnel to deliver accurate and timely testing results while maintaining high levels of compliance and inspection readiness.
This role involves managing and directing site implementations, in coordination with Resilience Digital and Central Product Quality and Lab Operations Excellence, of key laboratory management systems, including LIMS, ELN, CDAS, and reference standard management tools.
The ideal candidate will also partner with Digital Quality to ensure implementation of requisite controls to assure data integrity and manage adequate review and approval of instrument and method qualification/validation and transfer protocols and reports.
A strong background in analytical methods and method validation, including technology transfers, is essential for this role.
The ideal candidate should have significant experience in Supervisory/Managerial roles in Quality Control and technical backgrounds in HPLC/UPLC, ELISA, Kinetic binding assays, icIEF, molecular-based assays, spectrophotometric assays, FTIR, Raman, particle sizing by DLS, molecular sizing by MALLS.
The estimated salary range for this position is $145,000 - $205,000 per year, depending on qualifications, skills, and experience.
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