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Manufacturing Associate II/III, Downstream

Employer
Vaxart, Inc.
Location
South San Francisco, CA
Start date
Nov 30, 2022

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Discipline
Manufacturing & Production, Manufacturing/Mechanical
Required Education
Associate Degree
Position Type
Full time
Hotbed
Biotech Bay
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Job Details

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 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 Manufacturing Associate II/III to join our growing South San Francisco team!

Summary:

The Manufacturing Associate II will follow current Good Manufacturing Practices (cGMPs) and adhere to Vaxart Quality systems in the execution of Drug Substance Manufacturing Operations. The Manufacturing Associate II will execute process activities across a variety of manufacturing production activities such as filtration operations, Media exchange, chromatography, chromatography column packing and testing, tangential flow filtration, buffer preparation and aseptic operations.

Responsibilities:

  • Performs Downstream and Buffer preparation activities as part of the Drug Substance process under a cGMP compliance for successful batch execution and lot release.
  • Understanding of Cell thaw, Cell seed trains, Cell Passage, Bioreactor inoculation, Monitoring of Cell growth, but not required.
  • Cross-train and support Upstream activities as needed.
  • Trains junior associates in downstream operations to be technically qualified and well trained in cGMP manufacturing activities.
  • Develops, implements and updates manufacturing Standard Operating Procedures (SOPs), batch records (BRs), material specifications and other documentation needed for cGMP compliance.
  • Supports deviation investigations and reports so they are written accurately and appropriately as they occur and adhering to company’s Quality systems.
  • Supports the implementation of new technology and procedures into manufacturing as needed.
  • Other duties as assigned.

Requirements:

  • B.S. in Biological Sciences, Pharmaceutics, Engineering or equivalent work experience.
  • Minimum of 1-5 years of experience in the biopharmaceutical industry.
  • Minimum of 3 years of experience in the manufacture of bulk drug substance based on cell culture production.
  • Minimum of 1–5 years’ experience with cell culture operation of bioreactors preferred.
  • Minimum of 1- year experience with chromatography and TFF systems is preferred.
  • Experience working in a GMP environment executing manufacturing operations.
  • Experience executing Chromatography operations, Diafiltration (DF) and ultrafiltration (UF) activities as part of tangential flow filtration (TFF) operations using single use technology (SUT).
  • Experience with the set-up and operation of single-use chromatography and TFF skids is preferred.
  • Experience with chromatography column packing and testing preferred.
  • Experience with buffer preparation.
  • Experience with cell thaw, seed trains, cell growth passage, Bioreactor inoculation, media exchange, aseptic technique, and filtration operations.
  • Attention to detail adhering to cGMP practices, following Standard Operation procedures, and adhering to Quality systems.
  • Demonstrated ability to work and communicate collaboratively and effectively with others.
  • Must have strong critical thinking skills, initiative, and integrity.
  • 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.
  • Familiarity and knowledge of quality systems and cGMP operations.
  • Ability to safely lift 25 pounds.

Vaccination Requirement:

Vaxart has implemented a mandatory COVID-19 vaccination policy which requires our employees to be fully vaccinated against COVID as a condition of employment. Vaxart will make reasonable accommodations for valid exemptions based on disability, medical, or religious reasons. Vaxart prioritizes sound science and available facts to best ensure the ongoing safety of our employees and the community.

Vaxart offers team members a competitive compensation and benefits package, including a robust health plan, 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, 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 federal, state or local law, ordinance or regulation.

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 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.

Company

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.

Vaxart has filed broad domestic and international patents covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists. All intellectual property is fully owned by Vaxart, without any encumbrances.

Stock Symbol: VXRT
Stock Exchange: NASDAQ

Find Us
Website
Phone
650-550-3500
Location
170 Harbor Way
Suite 300
South San Francisco
CA
94080
US
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