Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene and cell therapy approach. bluebird bio seeks a technically-driven leader to lead and build out technical functions to manage manufacturing process ownership of launched products, technology transfer of manufacturing process to and among manufacturing sites, and manage the execution of process validation activities.
Will drive the strategy for technical support and life-cycle management of our late-stage manufacturing processes for viral vector and drug product production. This role encompasses leading our manufacturing sciences and technology functions and is ideally suited for a high-level professional with strong technical leadership skills and experience supporting complex biologics manufacturing processes. We are interested in candidates with a proven track-record of successfully integrating activities and perspectives across functions to achieve our ultimate goal to deliver therapies that transform the lives of patients.
About the role:
- Lead and drive the current and future strategy for manufacturing sciences and technology, including process technical support, technology transfers, process and equipment validation and process life-cycle management for commercial-stage vector and drug product processes globally
- 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.
- Facilitate/lead tech transfers for early and late stage hematopoietic stem and CAR T cell clinical programs to/from CMOs or internal manufacturing facilities and participate in the customer interface as required.
- Develop and mentor a high-performing team with a vision of setting industry-leading standards in this nascent field.
- Build processes and relationships with external and internal process development and manufacturing organizations.
- Identify risks and drive continuous process improvement through technological innovation and alignment with regulatory and commercial manufacturing requirements.
- Implement (and sometimes develop) post-approval process improvements with effective balance among quality, financial, and inventory risks
- Actively engage in the identification, sharing and adaptation of best practices cross-functionally and between manufacturing sites.
- Drive functional compliance to regulatory requirements, and quality systems in a GMP environment.
- Author, review, and approve CMC documentation for regulatory filings as well as attending pertinent regulatory meetings as the functional owner.
- Travel 20-30%
- A B.S. in the pertinent life sciences or engineering, with 10+ year’s relevant industry experience. Advanced degrees desirable.
- Demonstrated experience managing a diverse technical organization as well as external manufacturing providers, partners, and/or academic collaborations is required.
- Prior experience in successfully managing manufacturing sciences or process development functions in the complex biological processes is expected and experience in the cell or gene therapy field is a plus
- Proven track-record of successfully integrating activities and perspectives across functions
- Ability and track record of successfully supporting biologics programs through late-stage clinical development into commercialization is required.
- Thorough working knowledge of cGMP manufacturing.
- Technology transfer and extensive biologics technical and manufacturing 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, andb yourself
bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.
Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.