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Director, Drug Product Manufacturing - South San Francisco, United States - Vaxart Inc.
Description
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, Drug Product Manufacturing to join our growing South San Francisco teamWe are seeking an independent, motivated individual to join our formulations team aimed at developing novel vaccine formulations in tablets.
The Drug Product Director is responsible for leading Vaxart's drug product manufacturing operations at the South San Francisco manufacturing site.
The drug product manufacturing process includes drying operations, as well as blending, tableting, coating and packaging operations. This individual develops the manufacturing schedules and contributes to the development of departmental objectives. In meeting these goals, the Drug Product Director will ensure that the facilities are maintained in a cGMP-compliant state.The director manages day-day operations with a hands-on approach to all aspects of vaccine drug product production activities, including managing timelines, staffing, and daily operations as required to meet accelerated vaccine manufacturing schedules.
Additional responsibilities include evaluating and analyzing process data to improve throughput and yield, as well as writing reports to summarize manufacturing campaigns, and process improvements.
The director will communicate progress to the management team, Quality Assurance, Project Management, and other organizational stakeholders.Responsibilities:
Build and maintain a staff that is both technically qualified and well-trained in cGMP manufacturing, while providing a motivating environment and opportunities for their professional advancement in a safety-conscious environment.
Leads, oversees, and be involved in solid oral dosage manufacturing processes including lyophilization, blending, compression, coating, inspection, and packaging operations in a GMP compliant manner following all batch documentation and SOPs for successful batch release.
Directs manufacturing staff in drug product production and supports on-floor activities as required.Ensure consistent product quality through appropriate manufacturing programs and by working with other groups such as Quality Control/Quality Assurance.
Provides leadership in ensuring that all GMP raw materials and supplies are compliant with cGMP.Leads the effort of process definition, improvement, and troubleshooting by appropriate use of manufacturing resources and Formulation Development resources.
Develops, implements, and updates all manufacturing SOP's, batch records, material specifications, and other documentation needed for cGMP compliance.Ensures that deviation reports are written accurately and appropriately as they occur. Track and implement corrective actions.
Responsible for understanding and applying data generated from development experiments to manufacturing operations. Implements new technology and procedures into manufacturing.
Provides reasoned and timely input to Management and others in developing a structure and vision for manufacturing at Vaxart.
Contributes to facilities design and existing facility modifications, as necessary, as part of the project team.
Ensures effective implementation of cGMP and safety practices in the manufacturing area.
Requirements:
B.S. in Biological Sciences or Engineering or equivalent professional experience.
Minimum of 15 years of experience in the pharmaceutical/biopharmaceutical industry.
Minimum of 8 years of experience in drying technologies or tableting, and packaging processes preferred.
Minimum of 5 years of personnel management experience. Must have strong leadership skills, critical thinking skills, initiative, integrity, and strong interpersonal skills. Demonstrated ability to work and communicate collaboratively with other workers.
Highly motivated, able to multi-task, strict attention to detail and, open to being responsible for successful execution of tasks.
Good knowledge of quality systems, cGMP, regulatory, and industry standards.
Ability to function in a rapidly changing environment & handle multiple priorities.
Hands-on experience with blenders, lyophilizers, tablet compression, solvent coating, and packaging equipment preferred.
Experience working in a BSL-2 facility preferred.
Experience handling biological materials and working with respiratory protection.
Available to work on site.
Available to work in the evenings and weekends, as required.
Position may require domestic travel to CMO's.
In accordance with California's Pay Transparency law, Vaxart's base salary range for this position is approximately $150,000 to $230,000 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.
Director, Drug Product Manufacturing professionals in South San Francisco
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Kuo-Ching Chang
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