Relocation Assistance Offered
The Senior Manager of the Upstream Process Development group within theRESILIENCEGene Therapy franchise will:
- Define the Upstream Process Development strategy that clearly ties solutions to business and scientific problems, overseeing activities needed for its tactical implementation.
- Using excellent scientific, communication, and leadership skills, lead a group of development scientists and engineers as a senior leader in the Upstream Process Development group located in Waltham, MA
- Work collaboratively with other leaders throughout the network to establish objectives, priorities, and represent the function in stakeholder meetings.
- Operate with the mission to develop and transfer robust, scalable, cost-effective viral vector production processes forRESILIENCEGene Therapy partners and drive development and implementation of innovative internal technology platforms
- Establish and maintain an effective organization, ensuring that all the requisite scientific and technical resources, processes, and systems are in place to enable upstream development which includes scale-up and technology transfer to GMP drub substance manufacturing sites.
- Establish leadership across industry working groups and with regulatory agencies to advance Resilience’s vaccine development and manufacturing goals.
- Interface directly with customers to evaluate requirements and identify opportunities within development programs.
- Builds, develops, and leads a world-class upstream development team that is technically strong, partner-focused, innovative, and advocate to the highest standards without compromise.
- A deep knowledge of upstream processing, including recombinant protein expression, cell culture techniques, at small, intermediate and large scale, as well as development of scale down models.
- Hands-on experience in working with mammalian cell cultures in a variety of different bioreactors.
- Regularly review and provide analysis on related competitive technology, methods and equipment and potential impact on projects
- Recommend, acquire and maintain equipment suitable for current industry-standard upstream bioprocessing.
- PH.D. in Chemical Engineering, Cell Biology, Biochemistry or related discipline with a minimum of 7 years of relevant viral vector process development industry experience or Master’s degree with a minimum of 11 years of relevant industrial experience.
- Strong scientific background with extensive understanding of cell culture process development; biopharmaceutical analytical methods; equipment and facility design, scale-up and tech transfer; GMP regulations and relevant regulatory guidance's.
- Minimum of 3 years developing advanced solutions using transient transfection, Sf9/Baculovirus, producer cell line, or other relevant expression platforms to produce viral vectors forin vivoorin vitrogene therapy applications.
- Deep understanding of the advanced trends and regulatory requirements related to viral vector cell culture process development
- Extensive experience with experimental design, data analysis, organization and presentation of complex scientific data.
- The candidate should be a self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a GMP environment.
- Established external network of service providers, technical experts, suppliers, and technology providers.
- Ability to recruit, lead, manage, and motivate a diverse team across various functions.
- Demonstrated ability to work efficiently across multiple project teams and business functions.
- Experience in a customer-facing environment
- Strategic and innovative thinker; track record of fresh and insightful thinking by developing creative approaches to processes and practices
- Track record of building and managing high performing process development teams
- Demonstrated experience managing teams in a matrix environment preferred.
- Excellent written and verbal communication skills