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Director, Analytical Development

ElevateBio

This is a Full-time position in Waltham, MA posted June 8, 2021.

Reports to: Sr.

Director, Analytical Development and Quality Control

The Role:

ElevateBio is looking for a Director to establish the Analytical Development (AD) function at our Waltham, MA Basecamp facility.

In this role, you will work with a team of scientists to develop analytical methods for CMC activities including but not limited to process development, product characterization and Quality Control testing.

In addition, the Director of AD is responsible for building an analytical core laboratory for high through-put non-GMP testing in support of ElevateBio’s cell and gene therapy programs.

Here’s What You’ll Do:
Build and manage an analytical laboratory to support cell-based, molecular and biochemical method development and high-throughput non-GMP testing.

Work cross-functionally with Research, Process development, Regulatory and Quality to establish testing paradigms to evaluate product quality attributes and process parameters.

Hire and manage a team of scientists to develop, pre-qualify and implement analytical methods.

Facilitate analytical method transfer from external sites to ElevateBio’s internal test laboratories.

Author, review and approve test methods, protocols, reports, and relevant sections of regulatory submissions.

Review and approve material specifications and product shelf life based on available stability data.

Evaluate and implement new analytical methodologies/techniques to meet the needs of the business.

Participate in technical troubleshooting and GMP investigations where subject matter expertise is required.

Prepare, evaluate, and present data to internal and external stakeholders.

Requirements:
M.S.

or Ph.D.

in Biology, Biochemistry, or equivalent with 12+ years relevant experience.

Experience with the following cellular, immunological, molecular and biochemistry methodologies: cell culture, microscopy, flow cytometry, ELISpot, ELISA, MSD, ddPCR, qPCR, UPLC, DLS, electrophoresis.

Experience managing a relevant laboratory function.

Solid understanding of applicable compendial monographs and regulatory guidelines.

Ability to work in a fast-paced dynamic environment and to multi-task and/or prioritize work from multiple programs and projects.

Strong communication, interpersonal and organizational skills.

Ability to work with others to troubleshoot complex technical and scientific problems.

Broad technical proficiency and the ability to solve complex issues independently.

Knowledge of cell and gene therapy production is desirable.

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.

Would you require visa support or sponsorship to take a position with ElevateBio?*

Would you need to relocate in order to accept a position with ElevateBio?*