GMP Bioprocess Development Senior Scientist, Product Line Manager

This Position is Grant Funded

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GMP Bioprocess Development Senior Scientist, Product Line Manager

Duke Human Vaccine Institute (DHVI)

Role Summary

The process development Senior Scientist will serve as a product technical lead and oversee downstream development activities.  They will provide deep expertise to afford sufficient technical oversight in these areas to enable efficient development of processes to support phase I manufacture of novel immunogen constructs.  This role involves collaborative technical leadership across process development and supporting teams to derive GMP scalable processes for the manufacture of next generation vaccines for HIV, influenza, and emerging diseases such as coronaviruses.  This involves fostering biomolecular design of expressed constructs to enable efficient downstream purification development, derivation of empirical plans and execution oversight, and coordinate of efficient analytical assessments to facilitate accurate and informative collaboration discussion with various internal and external stakeholders.   Drafting process and product design intents that include the quality target product profile (QTPP) definition, as well as sustainment of technical readiness dashboards, risk assessments and technical transfer throughout the process development lifecycle are also commensurate to this role.  The Senior Scientist will serve as the primary subject matter expert for downstream process development and as a product line lead for expressed immunogen constructs.  The Senior Scientist will also identify and enable capability gaps and foster innovation within both process development and the GMP manufacturing suites.   

Responsibilities

• Lead downstream development and expressed protein projects in collaboration with other product line leads to derive the next generation of immunogens (30%)
• Facilitate technical transfer throughout the process development lifecycle in collaboration with the GMP-operation teams (20%)
• Coach and mentor downstream staff scientist (10%)
• Identify and enable capability gaps and foster innovation within process development and internal GMP-Operations (10%)
• Compile pivotal results and draft and present coherent and cohesive communication packages to foster understanding and derive collaborative decisions with sponsors and the GMP organization (10%)
• Ensure good documentation practices within the electronic notebook, inventory systems, and so on (10%)
• Oversee collaborative drafting of technical development reports and process technical transfer documents (10%)

Education and Experience

• Bachelor’s degree in a science, engineering or related field; an advanced degree (Master's or PhD) is preferred
• 13 years of relevant experience in the biopharmaceutical industry or equivalent
• A Master or PhD is preferred and with GMP experience
• Background in risk assessment or lean sigma is preferred
   

Required Skills

• Extensive experience in the development and implementation of bioprocesses (cell culture, protein expression systems, downstream unit operations, and analytical techniques)
• Demonstrated bioprocess innovation
• Demonstrated capabilities to develop suitable bioprocesses aligned with strategic program goals
• Demonstrated advanced ability to collaboratively solve complex problems aligned with strategic goals
• Superior oral and written communication skills
• Experience in leverage risk assessment to foster understanding and comprehensive collaborative decision making

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