Director - AAV/LV Virus, Process Development 9/13/2020
JOB DESCRIPTIONAPPLY TITLE: DIRECTOR- AAV/LV VIRUS PROCESS DEVELOPMENT
LOCATION: WALTHAM, MA
REPORTS TO: SR. DIRECTOR - PROCESS DEVELOPMENT
This role as Director of Virus Process Development will be a critical leader and mentor and will serve as the functional and strategic lead for all process development projects involving manufacturing AAV for gene therapies and Lentivirus to support genetically modified cellular therapies. Reporting to the Sr. Director of Process Development, the Director of Virus Process Development will have key relationships with ElevateBio business development (BD), manufacturing operations (MO), and technical operations (TO) teams and will partner with such teams to bring in projects that are within the scope of Base Camp expertise in AAV and LV manufacturing and align with our platform technologies. In addition, the Director of Virus Process Development will be responsible for supporting the development and characterization of processes to support ElevateBio subsidiary portfolio companies as necessary to advance those assets in the clinic.
HERE S WHAT YOU LL DO: * Lead and mentor a group of 6-8 scientists and research associates in AAV and LV related process development activities
* Participate in project team meetings to provide Virus expertise
* Participate in developing the long term platform strategies to support internal portfolio companies
* Work closely with BD to bring in potential clients/strategic partners that align with our platforms
* Establish process development group goals and manage project plans and timelines
* Direct the translation of research and development programs to GMP manufacturing
* Act as subject matter expert for both internal and external technology transfer activities
* Lead the implementation of innovative, next generation and industry leading technology for manufacture of viral vectors
* Direct process characterization activities for viral vectors and provide guidance for successfully process performance qualification activities
* Represents process development functions in cross-functional team forums
* Author, review and approve process transfer document to support GMP manufacturing activities.
* Authors CMC sections of regulatory filing including INDs and amendments and equivalent documents for US and ex-US filings
* Establish and manage key vendor relationships to support group activities
* Hire key talent and provide strategic leadership to junior staff
OUR IDEAL CANDIDATE * Acknowledged by peers and colleagues as a leader in the viral vector process development and manufacturing fields
* Motivated to work collaboratively with colleagues in Elevatebio s therapeutic development areas in a fast-paced environment for novel platform technology and therapeutic development
* Strong expertise in LV and AAV suspension scale up and manufacturing; Ability to drive development of 50L to 1000L suspension processes
* Familiar with icellis adherent processes
* Strong expertise in viral vector analytical methods
REQUIREMENTS: * PhD in biological sciences and a minimum 5 years experience in the biotech or pharma industry; or, a BS or MS with 10+ years of industry experience.
* Supervisory experience is required.
* Demonstrated proficiency with AAV, LV as well as molecular biology and other analytical methods required to support the development of robust manufacturing processes.
* Knowledge of adoptive cell therapy and/or gene therapy fields.
* Experience with gene editing techniques is a plus.
* Outstanding communication skills (verbal and written).
* Ability to manage multiple projects in a fast-paced environment.
* Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
WHY JOIN ELEVATEBIO?
ElevateBio is accelerating the future of biotechnology; developing the next-generation of cell, viral and regenerative medicine therapeutics for the treatment of severe diseases. We have launched a revolutionary new model that integrates innovators, infrastructure and capital to effectively develop cell, gene and related therapies for patients with severe and life-threatening disorders. With plans for a cutting-edge laboratory and manufacturing center already underway, we're building a world-class organization lead by expert talent with bench-to-bedside capabilities. ElevateBio is also a leader in corporate philanthropy and has taken a pledge to donate a portion of product sales to fund promising cancer research and to support cancer care in the developing world.
At the heart of the ElevateBio platform is ElevateBio Base Camp, a state-of-the-art research, development and manufacturing center for innovation in the Greater Boston Area to be staffed with a world-class team of scientists.
Next-generation product development for advanced therapies supported by global bench-to-bedside expertise shared across our portfolio of companies
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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