Downstream Manufacturing Lead
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 and eliminate the risk of needle-stick injury.
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 Downstream Manufacturing Lead to join our growing South San Francisco team!
* Please note that we cannot sponsor Visas at this time.
The Downstream Manufacturing Lead is responsible for leading the downstream activities of vaccine drug substance manufacturing operations in Vaxart facilities. This person develops the downstream schedules and contributes to the development of departmental objectives. In meeting these goals, the Downstream Lead will ensure that the downstream activities are completed in a GMP compliant manner. The lead manages day-day downstream operations with a hands-on approach to all aspects of downstream activities. The Downstream Lead is expected to be the internal expert of downstream activities using state of the art single-use systems. Manages downstream timelines and daily operations as required to meet accelerated COVID19 and other vaccine manufacturing schedules and resolves any problems that may arise. Communicates progress to the Manufacturing Manager as well as Quality Assurance and Project Management teams and other organization stakeholders as required.
- Leads the downstream manufacturing staff in drug substance production and supports upstream, buffer prep and drug product manufacturing as needed for successful batch execution and lot release.
- Knowledge and proficient with Unicorn software and AKTA Chromatography skids.
- Knowledge and proficient with chromatography column packing and testing activities.
- Proficient with Tangential Flow Filtration (TFF) operations executing Diafiltration (DF) and Ultrafiltration (UF) activities.
- Coach, guide, and train new associates in all Downstream Manufacturing operations.
- Lead tech transfer activities into clinical manufacturing such as training with development staff, performing comparability studies, generating raw material specifications, coordinating, and executing shakedown and/or engineering runs.
- Write, review and revise Quality documents (SOPs, BRs, Forms, Protocols, and Summary Reports).
- Lead day-to-day manufacturing process operations.
- Assist with execution of process planning/scheduling and resourcing of personnel.
- Develop training plans for GMP plant operators and execute personnel training.
- Performs, instructs, and directs others in downstream production of Drug Substance.
- Defines, implements and optimizes downstream manufacturing activities to successfully achieve manufacturing timelines.
- Train staff in downstream operations so they are technically qualified and well trained in cGMP downstream manufacturing activities.
- Support the effort of downstream process definition, improvement and troubleshooting by appropriate use of manufacturing resources and by influencing other groups such as Process Development, Quality Control, and Quality Assurance.
- Develops, implements, and updates all Downstream manufacturing SOPs, batch records, material specifications and other documentation needed for cGMP compliance.
- Ensures that downstream deviation reports (DRs) are written accurately and appropriately as they occur per company Quality systems.
- Responsible for understanding and applying data generated from development experiments to manufacturing operations.
- Implements new technology and procedures into downstream manufacturing.
- Provides reasoned and timely input to Management and others in developing a structure and vision for the manufacturing facility at Vaxart.
- Contributes to facilities design and existing facility modifications, as necessary, as part of the project team.
- Provides a safe working environment for employees.
- Evaluates employee efficiency and productivity.
- Other duties as assigned.
- Bachelor’s Degree in Biological Sciences, Pharmaceutics, Engineering, or equivalent work experience.
- Minimum of 5 to 20 years of experience in the biopharmaceutical industry.
- Minimum of 5 years of experience in the manufacture of bulk drug substance based on cell culture production.
- Minimum of 5 years of GMP downstream production activities.
- Experience in GMP operations using single use technology (SUT).
- Experience executing Diafiltration (DF) and Ultrafiltration (UF) activities as part of Tangential Flow Filtration (TFF) operations.
- Experience with the use and operation of AKTA Chromatography systems.
- Experience with Chromatography Columns Cleaning, Packing and Testing Operations.
- Experience and ability to lead the set-up and operation of single-use chromatography and TFF skids.
- Demonstrated ability to work and communicate collaboratively and effectively with others.
- Train and supports manufacturing associates in process operations.
- Must have strong critical thinking skills, self- initiative, integrity, and strong interpersonal and leadership skills.
- 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 manufacturing operations and other 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 safely lift 25 pounds.
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.