Scientist/Sr. Scientist, Downstream

We are looking for a Scientist/Sr. Scientist, Downstream to join our growing South San Francisco team!

Summary:

The Scientist/Sr. Scientist is responsible for understanding, designing, executing, and reporting purification processes with a focus on development and manufacture of Ad5 vectors used for oral vaccines. 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. 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. The successful candidate will be expected to work with in-house and partnering development and manufacturing organizations in tech-transfer and manufacturing support roles. Will also be asked to train and mentor 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. Assures 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. Assures that training and compliance records for themselves and staff are up to date and appropriate. Assures that all safety procedures are followed.
• Proactively communicates with internal and external stakeholders. Establish and foster relationships with contract manufacturing organizations.

Requirements:

• BS or MS in Bioengineering, Biochemistry, and other appropriate fields or 8 years of relevant industry experience or a Ph.D. in Bioengineering, Biochemistry, or closely related field with 5 years of relevant experience.
• Strong experience with production and purification of viral products.
• 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.
• Expert in sterile techniques and hazardous/infectious material handling