Vaxart Inc.
Assoc Dir Purification Process Development
Vaxart Inc., South San Francisco, California, us, 94083
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 Associate Director, Purification Process Development to join our growing South San Francisco team!
The Associate Director, Purification Process Development is responsible for understanding, designing, executing, and reporting purification processes with a focus on development and manufacture of Ad5 vectors used for oral vaccines. Must be very familiar with Clarification, Chromatographic, and NFDF type unit operations. Evaluate existing downstream methods and develop new methods appropriate for improved yield, larger scale, and improved or sustained product quality in the production of Ad5 viral vectors for use in an oral vaccine. The Associate Director, Purification Development must be able to work closely with Upstream and Formulation Development units as well as manufacturing organizations to define unit operations that fit manufacturing constraints and corporate timelines. A successful candidate will be expected to work with in-house and partnering development and manufacturing organizations in tech-transfer and manufacturing support roles. The Associate Director, Purification Development trains and mentor's junior scientists, to take a leading role in designing and organizing the purification development laboratory, and to establish a culture of general compliance, safe operations, and proper documentation and communication of results. Familiarity with viral vector production would be a significant asset.
**
Responsibilities: **
Manages lab-based purification development staff and contract service partners to provide data and informational support for development activities. Design and execute experimental protocols for purification development.
Writes and/or reviews protocols, purification development reports, batch records, standard operating procedures, and other technical reports in support of manufacturing and process tech transfer. Ensures that results are properly archived and communicated.
Responsible for understanding and applying data generated from experiments and literature used to modify/optimize process parameters. Evaluates new technology and procedures.
Manages and trains staff as appropriate in laboratory activities. Ensures that training and compliance records for themselves and staff are up to date and appropriate. Ensures that all safety procedures are followed.
Proactively communicates with internal and external stakeholders. Establish and foster relationships with contract manufacturing organization.
Requirements:
BS or MS in Bioengineering, Biochemistry, and other appropriate fields or 8 years of relevant industry experience, and a Ph.D. in Bioengineering, Biochemistry, or closely related field with 5 years of relevant experience.
A minimum of 2 years of prior management experience
8 years of relevant industry experience.
Strong experience with production and purification of viral products, experience with viral product purification is a significant enhancement.
Familiarity with mammalian cell culture in a GMP environment.
Strong communication and teamwork skills.
Ability to gain cooperation of others.
Strong experience with general or direct supervision to exempt employees and/or skilled nonexempt employees.
Strong knowledge of QC issues.
Experience in relevant Regulatory filings for PD output and knowledge of Regulatory requirements and regulations.
Expert in sterile techniques and hazardous/infectious material handling.
In accordance with California's Pay Transparency law, Vaxart's base salary range for this position is approximately
$180,000
-
$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.
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 Associate Director, Purification Process Development to join our growing South San Francisco team!
The Associate Director, Purification Process Development is responsible for understanding, designing, executing, and reporting purification processes with a focus on development and manufacture of Ad5 vectors used for oral vaccines. Must be very familiar with Clarification, Chromatographic, and NFDF type unit operations. Evaluate existing downstream methods and develop new methods appropriate for improved yield, larger scale, and improved or sustained product quality in the production of Ad5 viral vectors for use in an oral vaccine. The Associate Director, Purification Development must be able to work closely with Upstream and Formulation Development units as well as manufacturing organizations to define unit operations that fit manufacturing constraints and corporate timelines. A successful candidate will be expected to work with in-house and partnering development and manufacturing organizations in tech-transfer and manufacturing support roles. The Associate Director, Purification Development trains and mentor's junior scientists, to take a leading role in designing and organizing the purification development laboratory, and to establish a culture of general compliance, safe operations, and proper documentation and communication of results. Familiarity with viral vector production would be a significant asset.
**
Responsibilities: **
Manages lab-based purification development staff and contract service partners to provide data and informational support for development activities. Design and execute experimental protocols for purification development.
Writes and/or reviews protocols, purification development reports, batch records, standard operating procedures, and other technical reports in support of manufacturing and process tech transfer. Ensures that results are properly archived and communicated.
Responsible for understanding and applying data generated from experiments and literature used to modify/optimize process parameters. Evaluates new technology and procedures.
Manages and trains staff as appropriate in laboratory activities. Ensures that training and compliance records for themselves and staff are up to date and appropriate. Ensures that all safety procedures are followed.
Proactively communicates with internal and external stakeholders. Establish and foster relationships with contract manufacturing organization.
Requirements:
BS or MS in Bioengineering, Biochemistry, and other appropriate fields or 8 years of relevant industry experience, and a Ph.D. in Bioengineering, Biochemistry, or closely related field with 5 years of relevant experience.
A minimum of 2 years of prior management experience
8 years of relevant industry experience.
Strong experience with production and purification of viral products, experience with viral product purification is a significant enhancement.
Familiarity with mammalian cell culture in a GMP environment.
Strong communication and teamwork skills.
Ability to gain cooperation of others.
Strong experience with general or direct supervision to exempt employees and/or skilled nonexempt employees.
Strong knowledge of QC issues.
Experience in relevant Regulatory filings for PD output and knowledge of Regulatory requirements and regulations.
Expert in sterile techniques and hazardous/infectious material handling.
In accordance with California's Pay Transparency law, Vaxart's base salary range for this position is approximately
$180,000
-
$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.