Senior Associate Process Engineer - Vector Fill/ Finish/ Materials Science MSAT
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 focus of the MSAT Vector Senior Associate Process Engineer role is to support fill and finish technology transfer and validation activities of late stage and commercial vector manufacturing process for several gene therapies for both intercompany and intracompany (i.e. CMOs) sites. We seek candidates with proven ability to successfully work independently and collaboratively across functions to enhance product quality, quantity, and process efficiency. We are passionate about transforming the lives of patients, incredibly cool science, and bird puns.
HOW YOU’LL FLY
As a MSAT bird reporting to Process Engineer II, you'll help to bring more patients their bluebird days by:
- Collaborating with all relevant departments to coordinate technology transfer activities
- Tracking team activities and timelines to ensure that the deliverables within the project plan are met and are on-time.
- Providing leadership to generate options to resolve problems, prioritize, and decide appropriate courses of actions; implements decisions around fill/finish/aseptic processing
- Authoring and reviewing technical documentation related to internal and external fill/finish manufacturing activities including protocols, technical reports, manufacturing batch records, SOPs,
- change controls, deviations, regulatory submissions, and product impact assessments.
- Working cross-functionally across Program/CMC Teams, Process Development, Manufacturing, SupplyChain, Regulatory Sciences and Quality to provide technical assessment for engineering and process changes in a cGMP environment.
- Coordination of external testing supporting container integrity, shipping studies, validation and qualification of critical equipment
WHAT YOU’LL BRING
- BS/MS in engineering or scientific discipline with focus in biotechnology or biopharmaceuticals and 3+ years of experience.
- A successful candidate will possess excellent communication skills, including writing and oral presentation, and the flexibility to move between the planning and execution of each required function, as needed.
- General knowledge of process development and pharmaceutical manufacturing for biologics including fill/finish, equipment qualification, aseptic processing operations
- Experience supporting aseptic processing and fill/finish investigations is preferred.
- Experience with GMP quality systems including Deviations, CAPA, and Change control is preferred.
- Prior experience in the gene therapy field is a plus, but not required.
- Track record of completing deliverables within specified timelines
- Ability to work effectively in a collaborative team environment
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.
Our cornerstone is knowledge of the home, family, food and lifestyle markets.