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Vice President Manufacturing

Company: ElevateBio
Location: Waltham
Posted on: September 12, 2020

Job Description:

Reports to: Sr. Vice President CMC Operations

The Role:

ElevateBio is looking for a Vice President of Manufacturing that will be responsible for GMP manufacturing of cell and gene therapy products. The Vice President Manufacturing will be responsible for leading and managing daily manufacturing activities to ensure safe and timely delivery of a portfolio of cell and gene therapy products. The Vice President will act as the lead to build the manufacturing team and infrastructure and assist with commissioning, qualification and validation of the Base Camp Center of Innovation and GMP facility.

Here’s What You’ll Do:

Lead manufacturing department including policies and systems to ensure high quality GMP manufacturing

Lead all cross-functional GMP readiness activities for the manufacture of global cell and gene therapy products

Lead the development and implementation of commercial manufacturing strategy to support early and late stage GMP manufacturing

Develop and maintain training records, operating procedures and policies in accordance with Current Good Manufacturing Practices

Collaborate with process development to ensure a robust technology transfer strategy aligned with current industry best-practices (FDA guidance, ISPE standards, and others)

Effectively partner with Quality, Facilities and Engineering and Supply Chain to develop procedures for timely release of cell and gene therapy products

Establish scheduling strategy and implement tools for capacity planning in collaboration with supply chain department for effective utilization of GMP capacity

Apply leading-edge software solutions for optimal capacity utilization as needed

Work closely with Process Engineering group to ensure GMP manufacturing equipment and processing suites meet relevant GMP standards are qualified to support manufacturing campaigns

Develop a GMP training program for manufacturing team

Prepare GMP facility for inspection by regulatory authorities in support of product approvals

Support regulatory group during GMP and pre-approval inspections

Drive continuous improvement and operational excellence culture within the department through lifecycle management and best-in-industry innovation

Requirements:

Bachelor’s degree in scientific/engineering discipline required (advanced degree preferred)

10 years of relevant GMP manufacturing experience with 2+ years of leading a manufacturing team

Strong understanding of US FDA and EU EMA regulations and ICH guidelines for GMP manufacturing of cell and gene therapy products

Extensive experience in clean room manufacturing, aseptic processing and fill/finish is required.

Knowledge of cell and gene therapy manufacturing is strongly preferred

Knowledge of electronic systems is preferred (ERP, MES, EBR, LIMS)

Previous supervisory experience and demonstrated ability to lead a team effectively is required

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.

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? *

Keywords: ElevateBio, Waltham , Vice President Manufacturing, Other , Waltham, Massachusetts

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