Associate Director, Vector Manufacturing

Company: bluebird bio
Location: Somerville
Posted on: January 12, 2021

Job Description:

ABOUT THE NESTAt bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We---re 1100 doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.ABOUT THE FLOCKFor birds on our manufacturing team, patients and their families are counting on us to deliver for them, especially when it matters most. Come fly with us, this is your chance to help deliver un-incremental change in the emerging field of cell and gene therapy.bluebird bio seeks an entrepreneurial manufacturing professional to lead a cross-functional team responsible for supply from our external manufacturing partners (contract manufacturers, CMOs). Collaborating closely with Quality, Process Development, Manufacturing Sciences and Technology, and Supply Chain, we are seeking a patient-focused leader with a strong technical background and a proven track-record of meeting quality, supply, and cost commitments for clinical and commercial products.HOW YOU---LL FLYAs an Associate Director, Vector Manufacturing bird reporting to Vice President, Vector Manufacturing, you'll help to bring more patients their bluebird days by:Single point of accountability for all aspects of performance (Quality, Supply, and Cost) at bluebird---s designated CMO(s)Directly responsible for batch execution and relationship management as a peer to the CMO site headEstablishing the strategy and priorities for the cross-functional team and execute to ensure a best-in-class patient experience (including uninterrupted supply and rapid cycle times)Attracting, retaining, and developing a team of direct reports to build a high-performing team, with the ability to effectively collaborate with partners remotely.Monitoring overall CMO performance, proactively identify risks, and implement actions to reduce the overall risk profileDriving a continuous improvement mindset, through proactive process monitoring, rapid troubleshooting, effective CAPAs, and proactive process improvements to strengthen quality compliance, enhance process robustness, and reduce COGSEnsuring that technology transfers and process validations are executed Right First TimeEnsuring positive regulatory inspection outcomes through strong sponsorship of inspection readiness activities and direct interactions with health authoritiesTravel 10-20% WHAT YOU---LL BRINGYou---re the bird we---re looking for if you:Have a passion for addressing the critical unmet medical needs of patientsExperience leading a team responsible for overseeing GMP manufacturing for biologics; Prior experience with aseptic processing is a plus.An unwavering commitment to the highest standards of quality complianceExperience playing key roles in technology transfers for new processes and process monitoring/troubleshooting for existing processesAbility to collaborate cross-functionally, meet deadlines, and prioritize work in a dynamic environmentAdvanced verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriatelyStrong collaborative interpersonal skills with the ability to motivate others, influence, and resolve conflict situationsA B.S. in the relevant life sciences or engineering, with 10 years relevant industry experience. (Advanced degrees are very much desirable)All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth. bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

Keywords: bluebird bio, Somerville , Associate Director, Vector Manufacturing, Executive , Somerville, Massachusetts