Process Engineer I

Company: bluebird bio
Location: Cambridge
Posted on: April 9, 2021

Job Description:

On January 11, 2021, we announced our intent to separate our severe genetic disease and oncology businesses into differentiated and independent publicly traded companies. We will retain focus on severe genetic disease (SGD) and will launch our oncology business ("Oncology Newco") as a new entity, with the completed transition expected by the end of 2021. 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 Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. The Manufacturing Science and Technology (MSAT) organization at bluebird bio is a team of scientists and engineers responsible for the technical support and oversight of late stage and commercial manufacturing processes for small molecules, oligonucleotides, lentiviral-based vectors and stem and immune cell-based therapies across internal and external manufacturing sites. --HOW YOU'LL FLY The focus of the MSAT Vector Process Engineer II role is to lead and support both 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. The chosen candidate will have the opportunity to lead the commercialization activities for our rare disease and oncology pipelines. 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. As a MSAT bird reporting to an Associate Director--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
• Leading process performance qualification readiness activities for internal and external manufacturing
• Supporting interactions with health authorities during PAI/PLI and GMP inspections
• Authoring and reviewing technical documentation related to internal and external manufacturing activities including protocols, technical reports, manufacturing batch records, SOPs, change controls, deviations, regulatory submissions, and product impact assessments.
• Worksing cross-functionally across Program/CMC Teams, Process Development, Manufacturing, Supply Chain, Regulatory Sciences and Quality to provide technical assessment for engineering and process changes in a cGMP environment.
• Delivering technical CMC input for regulatory interactions related to lentiviral vector manufacturing processes including IND submissions/amendments, marketing authorization submissions, and inspections WHAT YOU'LL BRING You're the bird we're looking for if you:
  • Have a BS/MS/PhD degree in engineering or scientific discipline with focus in biotechnology or biopharmaceuticals with 6+/4+/0+ years' experience in late-stage biopharmaceutical development;
  • 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 cell culture, purification, and fill/finish operations
  • Experience with GMP quality systems including Deviations, CAPA, and Change control is a must
  • Prior experience in the gene therapy field is a plus, but not required.
  • Track record of completing deliverables within specified timelines 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. 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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Keywords: bluebird bio, Cambridge , Process Engineer I, Engineering , Cambridge, Massachusetts