Process Engineer II, MSAT
Bluebird Bio, Durham, North Carolina, 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
Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene and cell therapy approach in our new vector manufacturing facility in North Carolina’s Research Triangle. As a Process Engineer II, you will have responsibilities for critical aspects of process fit in the facility. The focus of this position is to provide Upstream and Downstream process support and expertise for leading and managing process transfer and GMP manufacturing operations of clinical candidates through validation for our gene therapy products.
HOW YOU’LL FLY
- Team leader for cross-functional tech transfer and process validation teams (including members from multiple sites) responsible for coordination, execution, and tracking program progress. May lead dedicated sub-teams and work as a point of contact for several programs.
- Serve as the Upstream (cell culture through harvest) and/or Downstream (clarification through sterile fill/finish) technical expert for the vector manufacturing process.
- Provide hands-on support of training runs and non-GMP Engineering Runs; perform hands-on experiments in the manufacturing area as needed.
- Provide technical support of GMP manufacturing runs.
- Support MSAT and Manufacturing documentation drafting/review with a strong understanding of equipment, critical process parameters, in-process testing, etc.
- Author and execute tech transfer plans, engineering studies, risk assessments, technical reports, change controls, and process validation plans/protocols.
- Work closely with Manufacturing, Quality Assurance, and other functions to successfully resolve deviations, investigations, change controls, CAPAs, etc.
- Use FMEA or similar risk-based approaches to troubleshoot processing issues.
- Ensure potential safety hazards are identified/shared and effective actions are rapidly implemented.
- Embed the highest standards of compliance with our quality systems into the site’s day-to-day activities.
- Must have proficient computer skills and be experienced using MS office software (Word, Excel and PowerPoint) and MS project. Experience using statistical software (such as JMP) and/or data management software (such as Skyland Analytics) is a plus.
- Must be willing to have a flexible schedule to support 24x7 manufacturing activities. Travel is expected to be approximately 10%.
WHAT YOU’LL BRING
- BS/MS in Engineering or a related field with 9+ years of experience in technical operations, manufacturing sciences, manufacturing, or related areas (or a combination of education and experience).
- Tech transfer and process validation of GMP pharmaceuticals experience is required, experience with ATMP preferred. Thorough knowledge of chemistry, process control, process scale-up, and statistics is desired.
- Experience with aseptic processing, media fill runs, and sterile filling and labeling operations is a plus.
- Familiar with FDA and EU regulations and GMP standards. Experience with agency filings and inspections is strongly preferred.
- Prior cGMP cell or gene therapy manufacturing experience is highly desired.
- Ability to lead and influence in a matrixed-team environment, meet deadlines, and self-prioritize and balance work from multiple individuals and multiple projects.
- Management experience preferred. Potential to manage a team of engineers as the group expands.
- Exceptional verbal and technical writing skills; ability to provide focus and clarity; able to handle confidential information and material appropriately.
- Independently motivated, detail oriented and good problem-solving ability.
- Excellent organizational skills to multi-task in an extremely fast-paced environment with changing priorities. Direct project management experience preferred.
- Willingness to take on other tasks as needed to support the facility start up and operations.
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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