Associate Director, Drug Product, Manufacturing Sciences & Technology
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
ABOUT THE NEST
At 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 FLOCK
The Manufacturing, Sciences & Technolgoy (MSAT) flock is an enthusiastic and collaborative team contributing to the overall success of our novel gene therapy approaches. bluebird bio seeks an outstanding candidate for a critical position within our MSAT organization, focusing on technology transfer and manufacturing of autologous cell therapies at CMOs. Candidates should have extensive experience with biologics manufacturing in a GMP setting, technology transfer, managing and mentoring staff, regulatory filings, supporting regulatory inspections, and working within highly matrixed cross-functional teams. In this role, you will have the opportunity to lead MSAT support of CMOs that manufacture autologous cell therapies (hematopoietic stem cell based) to ensure bluebird bio delivers innovative medicines to patients.
HOW YOU’LL FLY
As an/a MSAT bird reporting to the Senior Director, you'll help to bring more patients their bluebird days by:
- Serving as the accountable technical leader within a cross-functional team supporting external manufacturing of autologous cell therapies (hematopoietic stem cell based)
- Collaborating with Manufacturing and Quality counterparts within bluebird to ensure robust supply of autologous cell therapy products
- Collaborating with MSAT counterpart at CMOs to deliver timely and correct technical solutions to resolve investigations and to improve manufacturing performance and reliability
- Leading, managing, and mentoring staff within direct reporting structure and within a matrixed team environment
- Ensuring that team is fully aware of current and evolving GMP requirements applicable to the manufacturing of autologous cell therapies
- Ensuring self and team stay current on latest regulatory requirements for the manufacturing of autologous cell therapies
- Leading inspection support efforts on technical topics
- Leading technology transfers and process validation
- Interfaceing with process monitoring (i.e., CPV) team to review trends and takes proactive measures to improve process robustness and quality
- Identifing resource gaps within MSAT CMO support team and works to resolve those gaps
- Writing and reviewing sections of regulatory filings
- Serving as a leader and functional representative within a CMC team structure
- Leading complex investigations to ensure timely resolution and delivers robust technical package to support lot disposition
WHAT YOU'LL BRING
- B.S., M.S. or Ph.D. in a scientific or engineering discipline and 10+ years of experience for those who have B.S. or M.S. or 8+ years of experience for those who have a Ph.D.
- Extensive experience working in either cell and gene therapy or in biologics
- Extensive experience is leading product/process support within a GMP setting: leading investigations, technology transfer, process monitoring, process validation, and routine clinical/commercial support.
- Expertise in mammalian cell culture or autologous cell therapies
- Experience in functional representation or matrix leadership within a cross-functional team (preferably a CMC team)
- Experience in regulatory inspections of manufacturing facilities
- Experience and knowledge of regulatory filings
- Understanding of QbD approaches
- Track record of creative approaches to problem solving and improving efficiency of MSAT workflows
- Experience managing staff and strong leadership qualities
- Preferred experience in technology transfer to CMOs
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.
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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