Manager, Upstream Process Development

Job Code:

P1020

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Post Date:

March 26th, 2021

JOB DESCRIPTION

The Manager, Upstream Process Development, functions to manage the Upstream Process Development Team  and is actively engaged in process development within a team-based PD laboratory. The individual should display strong technical knowledge and scientific understanding of cell culture and upstream process parameters as well as having experience in process development at both small and large process scales. The individual will provide significant scientific and technical contributions within the Process Development Team.  The Manager should be well versed in interactions in a diverse setting.

RESPONSIBILITIES

All Upstream Process Development responsibilities including, but not limited to, the following:

  • Understand and value the role of time in the Lab with the Upstream Process Development Team.

  • Provide program-specific leadership and subject matter expertise for upstream process and development activities. Lead and mentor team members and direct laboratory activities to ensure that development milestones are aligned with program timelines.

  • Define development strategy for upstream processes considering robustness, scalability and manufacturing feasibility/suitability. This includes screening, optimization, scale-up and incorporating advanced feeding strategies as necessary, to establish robust and highly productive upstream processes and ensure technical success in manufacturing campaigns.

  • Establish sound system/process to structure the development activities and information management to ensure the efficient delivery of a well-organized data package.

  • Provide hands-on leadership in the laboratory as needed, ensuring clear communication of experimental plans to ensure successful execution, analysis and documentation, requiring excellent writing skills and the flexibility to move between the management and execution as needed.

  • Collaborate with Downstream Process Development, Analytical Development, Quality, Manufacturing and etc. to establish robust cross-functional planning to further advance the science.

  • Independently analyze data, present results and conclusions to the team

  • Generate, manage, evaluate, and maintain critical data in a highly organized manner. Author technical reports, tech transfer documents, and prepare scientific presentations as needed. Write/revise Batch Records, SOPs and WI’s as needed.

  • Lead upstream activity support for technology transfers, scale up and scale down, manufacturing operations and deviations / investigations by designing and executing appropriate studies

  • Collectively and Independently design and manage the execution of experiments (DOE) to generate optimal and robust upstream processes

  • Utilize upstream process derived data (e.g. bioreactors, metabolite analyzers) and literature research to monitor process performance, support deviation reports and technical investigations and aide in process optimization/development

  • Assess impact and facilitate closure of deviations, ensure appropriate scoping of change controls and CAPAs, and develop risk assessments related to upstream processes

  • Author and review technical protocols and reports, process summaries, study design and protocols, SOPs, etc.

  • Build and maintain good working relationships with internal and external stakeholders e.g. Research, Development, Quality, suppliers, partners and clients etc.

QUALIFICATIONS

  • MSc degree (PhD preferred) in a relevant scientific discipline e.g. Biology, Biochemistry, Virology, with 5+ (MSc) or 4+ (PhD) years of relevant experience

  • Experience in upstream process development and bioreactor operation with viral vectors (4+ years) or biologics (5+ years)

  • Minimum of 5+ years’ experience in Upstream Process Development

  • Minimum 5 years’ managing a Team of Scientists

  • Experience with Sartorius Equipment and Instrumentation preferred