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Assoc. Dir, Purification Process Development
3 months ago
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.
