Scientist/Sr. Scientist, Upstream Process Development

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Job description

We are seeking a Scientist/Sr. Scientist (Upstream Process Development) to join our growing South San Francisco team!

Summary:

The Scientist/Sr. Scientist of Upstream Process Development is responsible for designing, executing, and reporting experimental activities in cell culture process development laboratory with a focus on developing a next generation Ad5 cell culture production process. Will be asked to troubleshoot existing platforms and assist in manufacturing operations as well. Will communicate progress and results to group leader via technical reports and or presentations. Must be able to work closely with Downstream 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 organizing and maintaining the Cell Culture Process 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:

• Collaborate with process development staff.
• May supervise junior team members.
• Work with contract service providers in upstream drug substance process development activities and technology transfer to Manufacturing.
• Perform and instruct in mammalian cell culture and virus production. Will assist development of robust and cost-effective commercial scale production processes.
• Writes and/or reviews protocols, development reports, batch records, standard operating procedures, and other technical reports in support of manufacturing and process tech transfer. Ensures 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:

• PhD in Biological Sciences OR BS or MS Degree in Engineering, Biochemistry, Chemistry, Biological Sciences.
• 5-10 years of relevant experience.
• 0-3 years of prior management experience.
• Experience/familiarity mammalian cell culture in a GMP environment.
• Knowledge of stirred tank bioreactor operation and control.
• Familiarity with production and purification of viral products.
• Strong communication and teamwork skills.
• Ability to gain cooperation of others.
• Suggested general or direct supervision to exempt employees and/or skilled nonexempt employees.
• Knowledge of QC issues.
• Expertise with sterile techniques and hazardous/infectious material handling.