Associate Director/Director–Biophysical Analytical Development, Gene Therapy

Resilience.com

Waltham, MA, US
  • Job Type: Full-Time
  • Function: Life Sciences R&D/Engineering
  • Post Date: 02/20/2021
  • Website: resilience.com
  • Company Address:

About Resilience.com

RESILIENCE (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.

Job Description

RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.

RESILIENCE is seeking a talented Associate Director/Director of Biophysical Analytical Development of the Gene Therapy Franchise who will:

  • Define the Biophysical Analytical Development strategy that clearly ties to solutions to business and scientific problems, then oversee activities needed for its tactical implementation
  • Lead the validation and technical transfer of state-of-the-art analytical techniques in support of advanced characterization of RESILIENCE gene therapy products
  • Establish leadership across industry working groups and with regulatory agencies to advance RESILIENCE’s gene therapy manufacturing goals
  • Interface directly with partners to evaluate requirements and identify opportunities within development programs
  • Lead a team of senior and junior scientists and engineers in the development of novel analytical methods located in Waltham, MA
  • Collaborate with analytical groups in other Franchises to develop best practices and create a center of analytical excellence

Job Responsibilities

  • Development and qualification of analytical methods for viral vector testing.
  • Provide analytical characterization support within the RESILIENCE organization and with external groups.
  • Utilize external networks to maintain and enhance current knowledge of emerging technologies in bioanalytics to support improvements for existing analytical strategies.
  • Responsible for building and managing RESILIENCE’s Biophysical group, including talent recruitment.
  • Communicating technical information to internal and external partners.
  • Writing and reviewing technical documents and regulatory submissions
  • Manage and lead a team of 2-4 direct reports

Qualifications

  • Strong scientific background with extensive hands-on experience in a broad array of biochemical/biophysical techniques is required.
  • 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

  • PhD and a minimum of 8 years experience or MS and a minimum of 10 years experience in gene therapy or vaccine assay development
  • Demonstrated experience managing teams in a matrix environment preferred.
  • Excellent written and verbal communication skills.

Other Ideal Personal Characteristics

  • Hungry, humble, and a learning machine with an open, inquisitive mind with regard to the future of medicine and biomanufacturing
  • Embodies grit, rigor, service, EQ+IQ, builder mentality, velocity, and ownership
  • Smart, curious, flexible, able to contribute at a very high level, as well as possessing a hands-on manner, when necessary
  • Collaborative style, with an ability to build consensus among both internal and external stakeholders
  • A person of unquestioned integrity and moral character; an individual that others can trust without reservation

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.