MSAT Engineer II/III, Drug Product

About Us:

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 an MSAT Engineer II/III, Drug Product to join our growing South San Francisco team!

Summary:

The MSAT Engineer, Drug Product will be responsible for drug product technical manufacturing support in accordance with current good manufacturing practices (cGMP) for Vaxart’s Ph I/III GMP manufacturing at CMO’s. The Engineer II/III initiates MS&T activities and provides leadership for activities to ensure robust and reliable production processes are established through a thorough technology transfer process to enable each site to succeed in product delivery. The MS&T Engineer partners with Process Development, EHS, Quality and Manufacturing groups to ensure compliance and collaboration. This position will also interface with external CMO’s, providing expertise and process guidance.

Responsibilities:

• Provides technical process leadership to drug product manufacturing to support Ph I through Ph III cGMP manufacturing. Lead tech transfer efforts for internal and external manufacturing facilities and support activities through process validation.
• Supports manufacturing investigations as required with batch record review, data analysis of results, experimental investigation planning and writing/review of technical reports.
• Must be able to work closely with process development and Quality SME’s to support investigations. Manage investigations and address deviations and implement change controls.
• Manages technology transfer from development to internal and external manufacturing sites ensuring effective information flow, timeline execution, issue resolution, training, and documentation in accordance with governing tech transfer quality system requirements while leveraging robust risk management practices.
• Responsible for process scale up activities both internally and externally at CMOs.
• Be the primary point of contact for CMOs and be the person-in-plan (PiP) for critical manufacturing activities.
• Works with Manufacturing staff for the preparation and review of necessary technical documentation (SOP’s, BPR’s, specifications, etc.).
• Keep current on regulatory and quality requirements and follow Environment, Health & Safety policies.

Requirements:

• B.S. or M.S. in Biological Sciences, Pharmaceutics or Engineering
• Minimum of 8 years of experience in the pharmaceutical/biopharmaceutical industry.
• Minimum of 5 years of experience in lyophilization, tableting, and packaging processes.
• Demonstrated ability to work and communicate collaboratively with other independent workers and to train workers in new procedures, as necessary.
• Must have strong critical thinking skills, initiative, integrity, and strong interpersonal and leadership skills.
• Experience with DoE, statistical analysis, and report writing.
• The ability to communicate clearly and precisely, both orally and in writing, is essential.
• Highly motivated, able to multi-task, strict attention to detail and open to be responsible for successful execution of tasks.
• Ability to problem solve, think critically, and troubleshoot while working independently.
• Extensive knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development with prior experience through commercialization is preferred.
• Ability to function in a rapidly changing environment & handle multiple priorities.
• A flexible work schedule is required.
• Ability to safely lift at least 25 pounds.
• Available to work in the evenings and weekends, as required.
• Up to 25% domestic and/or occasional international travel to CMOs.

Vaxart offers team members a competitive compensation and benefits package, including a bonus program, stock options, 401K 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, 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 federal, state or local law, ordinance or regulation.