The Principal Scientist role within Downstream – Viral Vector Process Development is responsible for leading the strategy, development, and characterization of downstream manufacturing processes used to manufacture viral vectors for use in/as cell and gene therapy products. This individual will define and direct activities within Downstream Process Development team to plan, execute, and document experiments for the development of fit-for-purpose manufacturing processes. The Principal Scientist will serve as a technical leader within the Downstream Process Development team and support management of process, analytical, and characterization knowledge related to the Center for Breakthrough Medicine asset pipeline.
Responsibilities of primary importance are to lead and mentor a high performing team responsible for delivering work packages in partnership with clients to advance products from Research to Development, and on to GMP manufacturing. The successful candidate will take accountability to ensure all documentation and reports are accurate, complete, and suitable for use in support of production, characterization, and regulatory approvals.
The Principal Scientist will be responsible for developing the downstream portion of the processes, planning to avoid delays, and leading the activity to deliver a robust and effective product and manufacturing process.
· Serve as a scientific and technical leader for the downstream process and team.
· Contribute to the stand-up and optimization of the Downstream team within Viral Vector Process Development
· Establish and incorporate sound scientific and technical principles as well as Good Documentation Practices.
· Make decisions, based on the professional judgment, experience, and cGMP and clinical regulations/guidance.
· Proactively develop and sustain strong relationships with current customers and contractual services suppliers to the unit.
· Work with internal stakeholders in Process Development, Manufacturing, Supply Chain, Business Development, Analytical Development, & Program Management to successfully deliver on client programs.
· Understand and incorporate Quality by Design (QbD) for programs.
· Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 7+ years’ of industry experience, MS with 9+ years, BS with 11+ years preferred
· Thoroughly understand gene therapy manufacturing downstream processes along with associated equipment and technologies to support issue resolution for manufacturing operations
· Excellent organization, multitasking, and oral and written communication skills.
· Strong understanding of global regulations, regulatory filings, and process characterization
· Ability to work by influencing peers and their reports and gain their cooperation in dealing with multiple priorities in the delivery of projects.
· Ability to define problems, establish facts, draw valid conclusions, and make decisions.
· Ability to deal with abstract and concrete variables in situations where only limited standardization exists.
· Extremely high levels of flexibility, initiative, solution-orientation, and tenacity.