Associate Director, Quality Control

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.

Originally posted on Himalayas