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Senior Manager, Process Development – Nucleic Acids

Employer
Resilience
Location
Allston, MA
Start date
Sep 28, 2022

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Job Details

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.

Job Responsibilities

  • 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.

Qualifications

  • 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.

Preferred Experience

  • 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

#LI-MG1

Company

Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development. For more information, visit www.Resilience.com and follow us on Twitter @IncResilience 

Find Us
Website
Location
9310 Athena Circles
La Jolla
CA
92037
United States
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