Associate Director, MSAT, BaseCamp Waltham

2 weeks ago

Watertown, United States ElevateBio Full time

ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

The Role:

ElevateBio is looking for an outstanding candidate for critical position to lead our Manufacturing Science and Technology Organization in support of our growing client portfolio for genomic medicines. This role is responsible for leading and growing a team responsible for end-to-end technical support of GMP manufacturing of autologous/allogenic cell therapies, viral vectors, mRNA, and other modalities. Candidates should have extensive experience with biologics manufacturing in a GMP setting, technology transfer, managing and mentoring staff, regulatory filings, supporting regulatory inspections, and working within highly matrixed cross-functional teams. In addition to building out the MSAT organization to establish GMP-enabling change management, comparability, and data management systems at ElevateBio.

Here's What You'll Do:

  • Manage and expand the Manufacturing Sciences and Technology (formerly Technical Operations) organization for BaseCamp Waltham.
  • Provide key technical leadership for pre-clinical, clinical, and commercial programs across all aspects of the product lifecycle including technology transfer, process fit, process design, and manufacturing support. Launch business process and structure for process data reviews in collaboration with internal and external stakeholders.
  • Create and launch process monitoring/trending, process validation, and process performance qualification programs (PPQ). Support client and/or internal product PPQ activities and management for on market products.
  • Ensure successful delivery of GMP material in partnership with Manufacturing, Supply Chain, Quality and supporting functions by providing technical oversight of manufacturing batch execution, deviation management, troubleshooting, and batch disposition.
  • Support transfer of technical expertise and knowledge to the Manufacturing team through training, education, and support
  • Assist with the development and drafting study plans and protocols as required to support regulatory requirements, deviations response, and process changes.
  • Partner with CMC Regulatory and SMEs to develop content for regulatory submissions (INDs, BLAs, DMFs etc.)
  • Actively support internal and regulatory audits of BaseCamp Waltham.
  • Provide technical leadership for the design, construction, commissioning, qualification, validation, and operation of manufacturing expansion initiatives at ElevateBio.
Requirements:
  • Minimum Bachelor's Degree in Engineering, Science, or related field. Master's or Ph.D strongly preferred
  • At least 10 years of experience in a Manufacturing, Technical Operations, or GMP environment supporting complex products. Experience in autologous gene or cell therapy a plus.
  • Extensive experience is leading product/process support within a GMP setting leading investigations, technology transfer, process monitoring, process validation, and routine clinical/commercial support.
  • Experience working within a contract manufacturing or client service organization strongly preferred.
  • Demonstrated ability and strength in leading cross-functional teams within a matrixed organization.


Why Join ElevateBio?

ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms - including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform - with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.

We aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.

Our Mission:
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.

Our Vision:
We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.

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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