Associate Director, MSAT

ElevateBio

Waltham, MA, US
  • Job Type: Full-Time
  • Function: Technical/Customer Support
  • Post Date: 06/01/2021
  • Website: www.elevate.bio
  • Company Address: 139 Main Street Suite 500 , Cambridge, MA , 02142

About ElevateBio

ElevateBio is a biotechnology company that specializes in cell and gene-based therapies.

Job Description

The Role:


We are seeking an outstanding candidate for critical position to join our Technical Operations Organization.  He/She will build out the organization and led a team of talented engineers responsible for end-to-end technical support of GMP manufacturing. 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 Elevate Bio.


Here’s What You’ll Do:

  • Manage and build out the Manufacturing Sciences and Technology Team for Elevate bio, reporting to the Senior Director of Technical Operations
  • Lead a team of MSAT Engineers responsible for pre-clinical and clinical manufacturing for drug product manufacturing and vector projects, including upstream, downstream, and fill finish production
  • Execute the MSAT strategy, including identifying resource needs and the hiring and management of internal employees
  • Ensure successful delivery of GMP material, including providing technical oversight of manufacturing batch execution, manufacturing batch close out, and deviation management
  • Provide immediate campaign support for manufacturing during technical production issues or escalations
  • Work with the process development and manufacturing teams to provide technical support to Manufacturing to develop platform procedures, batch records, training, and other manufacturing resources as required to prepare for and execute processes.
  • Ensure adherence to GxP guidelines as indicated by phase of manufacture
  • Assist with the development and drafting study plans and protocols as required to support regulatory requirements, deviations response, process changes, etc.
  • Develop and maintain structure for process data reviews for internal and external production
  • Partner with Quality Assurance to ensure on-time creation and lifecycle management of MSAT systems and procedures required for the Quality Management System (technology transfer, comparability, process controls documentation, process performance review, etc.)

 

 

Requirements:

  • B.S., M.S. or Ph.D. in a scientific or engineering discipline and 10+ years of experience for those who have B.S. or M.S. or 8+ years of experience for those who have a Ph.D.
  • 10 or more years of relevant experience in the manufacturing environment
  • Extensive working knowledge of cGMP systems and FDA/EU regulations
  • Extensive experience is leading product/process support within a GMP setting leading investigations, technology transfer, process monitoring, process validation, and routine clinical/commercial support.
  • Project management skills, including strategic and tactical projects/tasks, tracking and adhering to budgets, reporting project and campaign metrics, and other project management tools
  • Experience in functional representation or matrix leadership within a cross-functional team (preferably a CMC team).
  • Hands-on industrial experience with cell culture, purification, and/or fill finish activities.
  • Team player and exhibit a willingness to meet project timelines and be a “working manager”
  • Strong verbal and written skills are required as well as effective interpersonal, technical, and troubleshooting skills
  • Outstanding planning, organization, and multitasking skills

 

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.

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.

 

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