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Director, Vector Process Development

Company: Colorado School of Mines Alumni
Location: Oklahoma City
Posted on: September 17, 2020

Job Description:

Colorado School of Mines Alumni Job Center Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene and cell therapy approaches. bluebird bio seeks an experienced professional to lead the lentiviral vector process development function. In this role you will have a leadership position within the Process and Analytical Development organization that encompasses lentiviral vector, cell processing and gene editing, and analytical development for oncology and severe genetic diseases. The position reports to the Vice President, Process and Analytical Development and is ideally suited for a professional with passion for and a proven track record of exceptional talent development and organizational leadership. There is a great opportunity to lead and evolve this function to support a broad portfolio and advance the manufacturing capabilities to deliver therapies that transform the lives of patients.

Lead and develop technical functions to deliver scalable, robust manufacturing processes for our viral vector platforms, including development of integrated control strategies and implementation of technologies to drive continued innovation.

About the role:

• Develop and mentor a high-performing team of scientists and engineers with a vision of setting industry-leading scientific standards in lentiviral vector process development

• Drive the continued development of robust, cost-effective, scalable lentiviral vector manufacturing processes for bluebird bio’s therapies for severe genetic disease and oncology

• Apply biologics development and continuous/automated manufacturing concepts, tools, and practices while driving to re-define how they are applied in this novel and growing field

• Apply Quality by Design principles to develop a deep understanding of the lentiviral vector platform manufacturing process and to define robust, integrated control strategies

• Identify risks and drive continuous process improvement through technological innovation and alignment with regulatory and commercial manufacturing requirements

• Collaborate with MSAT to develop and implement Process Performance Qualification (PQP) strategy and post-approval process improvements with effective balance among quality, financial, and inventory risks

• Build processes and strong relationships with external and internal manufacturing organizations

• Ensure compliance to regulatory requirements and quality systems in a GMP environment

• Support regulatory strategy and activities, including authoring and review of CMC documentation for regulatory filings

• Act as a first-line resource to manage the interface between other CMC, Quality, Regulatory, Clinical, and Program Management functions and to align the functional strategy with peer dependencies and with program, portfolio, and corporate goals

Requirements

About you:

• A PhD in the pertinent life sciences or engineering, with 10+ years relevant industry experience

• Demonstrated experience leading a diverse technical organization as well as interfacing with external manufacturing providers, partners, and or academic collaborations is required.

• Prior experience in successfully managing manufacturing sciences or process development functions in complex biological processes is expected and experience with LVV and/or AAV is a plus

• Proven track-record of successfully integrating activities and perspectives across functions

• Ability and track record of successfully supporting biologics programs through early- or late-stage clinical development is required.

• Technology transfer and extensive biologics technical experience is required.

• Strong interpersonal skills with the ability to motivate others, influence, and negotiate conflict situations

• Outstanding communication, analytical and organizational skills

• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders

• Ability to navigate and be successful in a fast-paced, highly-matrixed work environment

• A passion for addressing the critical unmet medical needs of patients

• Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

Job Information

Job ID: 54664638

Location:

Massachusetts, United States

Position Title: Director, Vector Process Development

Headquartered in Cambridge, MA, bluebird bio develops pioneering gene therapies for severe genetic diseases and cancers.

Associate Scientist II, Method Development and Qualification

Massachusetts, United States

3 days ago

Director, Method Development and Qualification

Colorado School of Mines Golden, CO 80402

Keywords: Colorado School of Mines Alumni, Oklahoma City , Director, Vector Process Development, Other , Oklahoma City, Oklahoma

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