Rezolute Bio

Develops monoclonal antibodies for rare diseases

Associate Director, Quality Control

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeRedwood City, CA, USAIn-person

About the Job

Requirements

A bachelor's degree in biology, chemistry, biochemistry, microbiology, or a related field is required.
At least 6 years of experience in a pharmaceutical or biopharmaceutical Quality Control or Analytical Science environment is required; biologics experience is preferred.
Detailed knowledge of analytical techniques and compendial methods used for testing proteins and small molecules is required.
Proficiency in Good Manufacturing Practice analytical data review is required.
Understanding of laboratory investigation methodology for out-of-trend and out-of-specification results is required.
Knowledge of Good Manufacturing Practice principles and regulatory guidance is required.
Technical writing competency, including expertise authoring method protocols and reports, standard operating procedures, and Quality System records such as deviations, investigations, and change controls, is required.
Prior use of a laboratory information management system application or electronic database is required.
Proficiency with Microsoft applications, including Word, Excel, Outlook, SharePoint, and Teams, is required.
The role requires a data-driven approach, attention to detail, problem-solving ability, ability to work independently while maintaining direction, ability to adapt to changing priorities, timely articulation of issues to management, self-motivation, ability to interact with a multidisciplinary remote-based team, and effective written and verbal communication skills.

Responsibilities

Review raw data and data summaries provided by contract testing facilities.
Provide timely feedback to testing laboratories regarding necessary corrections to raw data and data summaries.
Perform electronic data entry and verification.
Maintain inventory of reference standards and critical reagents at contract testing facilities.
Manage the qualification and requalification of new reference standards and critical reagents.
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.
Review deviations, out-of-specification and out-of-trend investigations, supplier change notices, and change-control records as a Quality Control subject matter expert.
Author, review, and revise Quality Control standard operating procedures.
Manage submission of Quality Control documents into the electronic document management system.
Participate in preparing regulatory documents, including IND, IMPD, BLA, NDA, and MAA submissions, and responses to requests for information, including verification of data content.
Participate in preparing Annual Product Quality Reviews, including verification of data content.
Perform other duties as assigned.

Desired Qualifications

Experience with biologics is preferred.
Previous partnership with an external contract laboratory coordinating activities between sponsor and service provider is preferred.
Prior authorship of regulatory submissions, including IND, IMPD, BLA, NDA, and MAA, is preferred.
Previous contribution to the annual product quality review process is preferred.

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.

About the Company

Rezolute Bio

Develops monoclonal antibodies for rare diseases

Rezolute Bio develops therapies for rare diseases, led by RZ358 for congenital hyperinsulinism and RZ402 for diabetic macular edema. RZ358 is a human monoclonal antibody that binds insulin to reduce its activity, aiming to lessen hypoglycemia, while RZ402 is an oral plasma kallikrein inhibitor for DME. The company differentiates itself by targeting rare, unmet-need conditions and pursuing late-stage candidates in both antibody and small-molecule formats. Its goal is to bring approved therapies to patients by advancing its programs through development to commercialization.

Company size: 51-200
Company stage: IPO
Headquarters: Louisville, KY
Founded: 2010

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