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Director, Vector Process Development

Company: bluebird bio
Location: Cambridge
Posted on: September 16, 2020

Job Description:

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

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

Will you now or in the future require bluebird bio to commence (“sponsor”) an immigration case in order to employ you (for example, H-1B or other employment-based immigration case)?  *

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Your privacy is important to us. bluebird bio, Inc. will use the information provided on this form to evaluate you for the position you are applying for and stay in contact with you for recruiting and hiring purposes. Please take a moment to read the Data Privacy Consent  located here and provide consent to the collection, processing, and notification of your rights regarding your personal information below. For more general information on how we will use, store, and protect the personal information provided through this form and on the website, please read our privacy policy located  here .

Read the Data Privacy Consent and select "I accept" to agree to the collection and processing of your personal information.

U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at bluebird bio are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary . Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Gender Are you Hispanic/Latino? Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

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Voluntary Self-Identification of Disability Why are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .

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Keywords: bluebird bio, Cambridge , Director, Vector Process Development, Other , Cambridge, Massachusetts

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