Job description
ABOUT THE NEST
The nest is a place where every role has meaning, every team member is respected, and every day is a chance to fly higher. When you join bluebird bio, you're not just landing a new gig, you become part of a flock that's pursuing curative gene therapies to give patients and their families more bluebird days. We are doers, thinkers and collaborators who embrace and live by our values:
- Persist for Purpose
- Be Compassionate
- Stay humble and curious
- Keep it real
- Celebrate (sm)all wins
Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
ABOUT THE FLOCK
The focus of the MSAT Sr. Process Engineer role is to support vector manufacturing, Fill & Finish manufacturing activities of late stage and commercial lentiviral vector manufacturing process for gene therapy at CMO 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
You'll help to bring more patients their bluebird days by:
- Collaborating with all relevant departments to coordinate technology transfer/Process validation/ commercial manufacturing 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 Upstream/downstream manufacturing and fill/finish/aseptic processing
- Authoring and reviewing technical documentation related to internal and external Upstream/downstream and 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, Supply Chain, 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
- Leading complex investigations to ensure timely resolution and delivers robust technical package to support lot disposition
WHAT YOU'LL BRING
You're the bird we're looking for if you have:
- BS/MS in engineering or scientific discipline and 5+ years of experience.
- 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 upstream/downstream & fill/finish, equipment qualification, aseptic processing operations
- Experience supporting upstream/downstream 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
- Track record of completing deliverables within specified timelines
Hybrid preference for this role however remote candidates will be considered
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.
jjbodyshop.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, jjbodyshop.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, jjbodyshop.com is the ideal place to find your next job.