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Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI)
Position Description
This position is responsible for management of Rezolute ’s clinical and commercial product testing program. The Associate Director, Quality Control acts as a liaison between Rezolute and its contract test laboratory (CTL) / CMO partners who perform our release and stability testing. The successful candidate will support Rezolute ’s objectives by acting as a Quality Control subject matter expert during internal stakeholder collaborations and external team meetings.
Principle Duties and Responsibilities Include:
Manage data review program
Review raw data and data summaries provided by contract testing facilities
Provide timely feedback to testing laboratories regarding necessary corrections to raw data and summaries
Perform electronic data entry and verification
Manage reference standard and critical reagent program
Maintain inventory of reference standards and critical reagents at contract testing facilities
Manage the qualification and requalification of new reference standards and critical reagents
Manage analytical method lifecycle
Design and maintain the analytical method monitoring program
Recommend improvements to existing test methods
Manage the transfer of test methods to contract laboratories including review and approval of protocols and reports
Participate in the development and validation of new test methods
Initiate and review Quality System records
Review deviations, OOS/OOT investigations, supplier change notices and change control records as Quality Control subject matter expert
Author, review and revise Quality Control SOPs
Manage submission of Quality Control documents into electronic document management system
Support regulatory filings
Participate in the preparation of regulatory documents (e.g., IND, IMPD, BLA, NDA, MAA) and requests for information including data verification of content
Participate in the preparation of Annual Product Quality Reviews including data verification of content
Other duties as assigned
Qualifications/Requirements:
Bachelor’s degree in biology, chemistry, biochemistry, microbiology, or related field 6+ years in pharmaceutical/biopharmaceutical Quality Control / Analytical Science environment; experience with biologics preferred Detailed knowledge of analytical techniques and compendial methods used for testing of proteins and small molecules Proficiency in GMP analytical data review Demonstrated understanding of laboratory investigation methodology for OOT and OOS results Demonstrated knowledge of GMP principles and regulatory guidance Competent technical writer with expertise in authoring method protocols and reports as well as SOPs and Quality System records (deviations, investigations, change controls) Prior use of a LIMS application or electronic database Proficient with Microsoft Applications (Word, Excel, Outlook, SharePoint, Teams, etc.) Data-driven mindset with eye for detail Robust problem-solving abilities Capable of maintaining direction while working independently Ability to identify and adapt to changing priorities: determine what matters most Ability to articulate issues to management in a timely manner Self-motivated: ability to interact with a multi-disciplinary remote-based team Effective written and verbal communication skills
Preferred Experience, Special Skills and Knowledge:
Previous partnership with external contract laboratory to coordinate activities between sponsor and service provider
Prior author of regulatory submissions of IND, IMPD, BLA, NDA, MAA
Previous contribution to annual product quality review (APQR) process
Rezolute (RZLT) currently anticipates the base salary for the Associate Director Quality Control role could range from $ 185,000 to $200,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.
Qualifying employees are eligible to participate in benefit programs such as:
Health Insurance (Medical / Dental / Vision)
Disability, Life & Long-Term Care Insurance
Holiday Pay
Tracking Free Vacation Program
401(k) Plan Match
Educational Assistance Benefit
Fitness Center Reimbursement
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.