Senior Director, Cell Therapy & Viral Vectors, MSST

Resilience.com

Boston, MA, US
  • Job Type: Full-Time
  • Function: Life Sciences R&D/Engineering
  • Post Date: 04/04/2021
  • 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.

 Role

  • Provide unsurpassed technical oversight and expertise in the development, transfer, validation and analysis of viral vector processes within and into Technical Operations
  • Enable excellence in the application of QbD across RESILIENCE.
  • Ensure that the network of manufacturing and development assets supporting the Cell Therapy and Viral Vector Franchises, as well as acquired technologies, are assessed and, where pursued, integrated into RESILIENCE, efficiently and effectively.
  • Assure that cell therapy and viral vector development and manufacturing network strategy is articulated, updated, as necessary, and implemented,

Responsibilities

  • Serve as the senior cell therapy and viral vector technical lead between the business, development and operations
  • Create and implement leading edge innovations in how to accomplish validation, technology transfer and life cycle management of processes
  • Process owner of assigned QbD, Technology Transfer, Process Performance Qualification and Continued Process Verification workflows. Develop standards, systems, tools and templates, with MSST colleagues, to allow the effective and efficient implementation of these workflows.
  • Ensure knowledge of, and adherence to, the Resilience workflows across the Cell therapy and Vector Franchises and Production. Assures that these workflows address the latest expectations from customers and health authorities
  • Articulate and maintain the strategic basis for cell therapy and viral vector operations within the multi-modal, distributed network of manufacturing and development sites
  • Define enabling RESILIENCE Centers of Excellence, with MSST colleagues, and lead one of these cross-functional/franchise centers.
  • Engage Franchise and Operations stakeholders to ensure that the technical needs of the organization are reflected in Business Development activities
  • Provide technical due diligence for asset and technology targets
  • Engage and collaborate with Local Manufacturing Support organizations to ensure common and coordinated approaches to this support as well as to provide assistance, when necessary, for critical investigations or manufacturing issues
  • Create collaborative networks which promote and facilitate the transparent flow of data, information, knowledge and process insight
  • Facilitate the implementation of RESILIENCE X innovations into the Cell Therapy and Viral Vector Franchises and Technical Operations

Qualifications

  • Strong technical knowledge across a broad range of bioprocessing operations (upstream, downstream, analytics) within the cell therapy and viral vector space; CART, AAV and Lenti virus expertise of particular value
  • In depth knowledge of GMPs as reflected in FDA, EMA and ICH requirements
  • Demonstrated experience in the implementation of QbD principles
  • Strong problem-solving mindset, responsiveness, attention to detail with demonstrated sound quality and business-oriented decision-making capabilities
  • Highly flexible individual with an agile mind
  • Listens with the intent to understand, is principled in your beliefs yet unafraid to probe them
  • Continuous improvement orientation
  • Thrives in a complex cross-functional environment
  • Creative leadership competencies, leads by example, through leveraging their own credibility and through influence
  • Superlative written and oral communication skills
  • Team orientation with a healthy streak of independence
  • Brings to bear insights from multiple technology transfers

Preferred Experience

  • MS/PhD in a scientific or engineering field of study
  • 15+ years of experience in Development, Quality or Manufacturing within the biopharmaceutical space

 

COVID 19 Alert – Resilience is closely monitoring the Coronavirus Disease (COVID-19). With a focus on candidate and employee safety, we have implemented a temporary process change shifting all in person interviews to be conducted virtually until further notice. 

Equal Opportunity Statement

At Resilience, we believe that the business of business is to improve the state of our world. Each of us has a responsibility to drive Equality in our communities and workplaces. We are committed to creating a workforce that reflects society through inclusive programs and initiatives such as equal pay, inclusive benefits, and more. Resilience is an Equal Employment Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance. Resilience welcomes all.

Resilience does not accept unsolicited headhunter and agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience.

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