Director, Quality Control - Vaxart

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration.

Vaxart has demonstrated that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart's first immuno-oncology indication.

Our mission is the promotion of global health through the development of effective vaccines that can be administered by tablet rather than by injection, providing for the simple and efficient distribution and administration of safe vaccines in any setting.

We are looking for a Director, Quality Control to join our growing South San Francisco team!

The Director, Quality Control ensures that activities related to release, stability and in-process testing and method qualifications/validations are completed promptly as in-house and/or at Outside Testing Labs (OTL's) associated with the manufacture of drug substance and drug product for Vaxart's product platform technology. Responsibilities include technical review of protocols associated with method qualifications/validations, transfers, and stability studies. Strong analytical skills and prior experience in root cause analysis, deviation management and change control and other quality systems is required. Prior experience with product development activities and special studies required to support a BLA application is required. Prior experience with managing OTL's is required. A successful candidate must possess strong understanding of cGMP requirements and ICH, FDA and other pharmaceutical industry regulatory guidelines. A strong technical understanding of biopharmaceuticals and/or vaccines is highly desired.  This position collaborates closely with cross-functional team members, including analytical development, quality assurance, manufacturing and process development, regulatory and clinical operations.

Responsibilities:

• Leads with strong leadership command, for all aspects of quality control and effectively manage employees
• Participates in all regulatory audits and inspections.
• Ensures release testing of drug substance and drug product manufactured in-house or at OTL's meets GMP requirements and project timelines.
• Provides oversight analytical method validations/transfers for drug substance and drug product at OTL's. Write/review method validation and transfer protocols and reports. Ensure technical and regulatory compliance.
• Provides leadership for in-house and OTL laboratory investigations related to discrepancies and deviations, OOS/OOT's results to ensure prompt and thorough investigations.
• Periodically evaluate and propose improvements to existing analytical methods. Plan and facilitate studies to support method validation/transfer activities as required.
• Establish a system for tracking and trending release and stability data for batch analysis and shelf-life establishment.
• Maintains internal change control for validated methods and regulatory documents and assists in the change control process at OTL's.
• Establish, monitor, and report key QC performance indicators/metrics for quality management review; use the indicators/metrics to drive operational, process and quality improvements.
• Prepare and review CMC/Quality sections of US and ex-US regulatory filings.
• Keeps abreast of industry developments and translates into corporate requirements and standards for analytical QC testing and stability programs.

Requirements:

• BS degree in Chemistry, Biochemistry, Molecular Biology, Virology or related scientific disciplines or equivalent experience, + 15 years of experience, 5 years of experience must be in Quality Control or cGMP laboratories.
• Experience with Virology, Bioassays, NGS (sequencing), Chromatography and Spectroscopic Analytical Techniques, and PCR and Molecular tools.
• Hands-on experience with method development, validation, and transfer in support of biopharmaceutical and vaccine manufacturing.
• Prior experience related to managing external OTL's.
• In-depth understanding of CMC regulatory requirements and experience with compiling CMC sections for regulatory filings. Experience with late-stage development products a plus.
• Working knowledge of cGMP requirements, ICH, FDA, USP and other pharmaceutical industry regulatory guidelines.
• Detail-oriented with exceptional organizational, leadership and project management skills.
• Excellent written and verbal communication skills.
• Self-directed individual who can work in a fast-paced, changing yet collaborative environment.
• Must have life sciences industry background and prefer some previous “startup” company experience.

In accordance with California's Pay Transparency law, Vaxart's base salary range for this position is approximately $$212,000 - $240,000 USD annually. The actual salary for this role will vary based on a variety of factors including education, job-related knowledge, and experience. This range does not include equity, benefits, bonuses, or other non-monetary compensation which may be included.

Vaxart offers team members a competitive compensation and benefits package, including a robust health plan, bonus program, stock options, 401(k) with employer matching, tuition assistance, and work-life balance.

Vaxart is an Equal Opportunity Employer and values diversity. We are committed to the principles of equal employment opportunity and affirmative action for all applicants and employees. Equal opportunity and consideration are afforded to all qualified applicants and employees in personnel actions, which include recruiting and hiring, selection for training, promotion, rates of pay or other compensation, transfer, discipline, demotion, and layoff or termination. Vaxart does not unlawfully discriminate on the basis of race, color, religion, sexual orientation, marital status, pregnancy, gender identity, gender expression, family medical history or genetic information, citizenship, national origin or ancestry, sex, age, physical or mental disability, medical condition, veteran status, military status, or any other basis protected by.

NOTICE TO RECRUITERS AND STAFFING AGENCIES: Vaxart, Inc. has an internal recruiting department. Vaxart may supplement that internal capability from time to time with assistance from temporary staffing agencies, placement services, and professional recruiters ('Agency'). Agencies are hereby specifically directed NOT to contact Vaxart employees directly to present candidates.  Vaxart's recruiting team or other authorized Vaxart personnel must present ALL candidates to hiring managers.

To protect the interests of all parties, Vaxart will not accept unsolicited resumes from any source other than directly from a candidate. Any unsolicited resumes sent to Vaxart, including unsolicited resumes sent to a Vaxart mailing address, fax machine or email address, directly to Vaxart employees, or to Vaxart's resume database will be considered Vaxart property. Vaxart will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Vaxart will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees.

The Agency must obtain advance written approval from Vaxart's recruiting function to submit resumes, and then only in conjunction with a valid fully executed contract for service and in response to a specific job opening. Vaxart will not pay a fee to any Agency that does not have such an agreement in place.

Agency agreements will only be valid if in writing and signed by an officer of Vaxart or their designee. No other Vaxart employee is authorized to bind Vaxart to any agreement regarding the placement of candidates by Agencies. Vaxart hereby specifically rejects, and denies any liability under, any agreement purporting to be accepted based on negative consent, negotiation with a candidate, performance, or any means other than the signature of a Vaxart officer.