Title: Supervisor, Quality Control (temp to perm)

Aerovate (AVTE) is a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of people with rare cardiopulmonary disease. Our team has spent their careers in cardiopulmonary disease research, drug and aerosol development, commercialization and company building.

Our exceptional team of experts, industry veterans, and scientists is uniquely equipped to overcome the current challenges of treating these diseases and deliver novel therapeutics to make a meaningful difference for patients.

At Aerovate, we know the diversity of our team’s backgrounds, talents, skills, and experiences not only makes us unique, but makes us stronger. Tenacious in our pursuit to make a difference and helping each other along the way, we know we can achieve better therapies to make a meaningful impact for patients.

Why Aerovate:

Aerovate fosters an uplifting environment, collaborative peers, and a passion for learning that translates into making a difference for people with cardiopulmonary disease and their communities.

Aerovate’s culture is one of inclusion, excellence, and respect in every way – for each other, the science, the community, and our mission. Both at work and in the clinic, we are committed to recruiting individuals that exemplify diversity in culture and life experience and are always striving to grow and improve. We recognize the urgency of our efforts, and we accept the challenge to do what’s right for our patients and their communities.

Position Summary:

The successful candidate will have extensive experience in drug product and drug substance development and be familiar with all phases of clinical development leading to commercialization. They will have a particular focus on CMC matters of quality control, regulatory, release and stability specification development, stability studies and in-vitro drug product characterization studies. Will have a strong background in data management, auditing of quality control data sets, summarizing data into reports/presentations, statistical data analysis/trending and managing data history files. Will be well versed with cGMP compliance and implementation for both early and late phase projects. Will be familiar with analytical methods and method development and validation. Able to author CMC related sections for both US and ex-US filings; has experience supporting regulatory review cycles. This role will be particularly focused on managing data integrity efforts for all Analytical and Quality Control GMP data ensuring traceability and accuracy of related sections in the NDA, MAA, IND, IMPD to filed technical reports in our validated documentation system to laboratory notebooks as needed.

Responsibilities:

• Data integrity practices for collection, review, audit and archiving in validated document management system.
• For reporting and presenting data summaries and/or trends to senior management.
• Closely with QA to ensure compliance with governing procedures and data reporting is completed per project timelines.
• Regulatory activities by writing, authoring, and auditing protocols and reports, especially those relating to batch and stability data for drug substance, intermediates, raw materials, device and drug product.
• Data management of registration stability studies, drug product characterization studies, and associated regulatory documentation.
• With third-party laboratories and/or manufacturing sites for project collaboration and completion of data review.
• Highly functioning internal and external working relationships.

Qualifications:

• In an applicable field of study with 6+ years, or a BS in an applicable field of study with at least 8+ years of industry experience.
• Experience with analytical methodology as well as managing their applications to stability studies and other drug development studies.
• With data trending and use of the statistical software JMP for data modeling.
• Authoring the CMC sections of US and EU regulatory filings and able to respond quickly to any feedback from regulatory authorities is required.
• Knowledge of and ability to interpret and strategically apply FDA, EMA and ICH guidance to support laboratory activities.
• As needed to visit AVTE offices and laboratory in the Boston and San Francisco areas as well as potential site visits for supporting testing and manufacturing activities. International travel may also be needed.
• Experienced with inhaled dry powder dosage forms is preferred but at a minimum must have extensive experience working with solid-state dosage forms.

All interested candidates can submit an updated resume to careers@aerovatetx.com.

Aerovate Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws.