Process Specialist 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 facility in North Carolina’s Research Triangle. As a process specialist, responsibilities will include execution of quality risk assessments, supporting deviation closure and CAPA implementation, change controls ownership and implementation, and author/review of other technical documents, as well as process troubleshooting and problem solving. This individual will work with the cross-functional bluebird team, including Quality Assurance, Quality Control, Facilities, Process Development, and Manufacturing to ensure compliant manufacturing procedures, equipment and facility across the plant.
HOW YOU’LL FLY
Technical writing to support manufacturing operations including but not limited to: standard operating procedures (SOPs), technical reports for raw materials (including raw material risk assessments and leachable/extractables reports), engineering test plans/reports, change controls and deviations.
• Review of product support documentation (e.g., batch records, validation protocols and reports, experiment test plans and reports, etc)
• Perform appropriate root-cause analysis for events utilizing investigation tools (e.g., 5 Whys, Fishbone Diagrams)
• Assign proper corrective action and preventive action (CAPA) to resolve and prevent recurrence of events.
• Utilize appropriate risk management tools such as FMEA, HACCP, and PHA. Facilitate risk assessments and author summary reports.
• Facilitate and participate in meetings, aligning internal review team and area subject matter experts on an agreed to investigational path forward.
• Collect data from manufacturing and prepare necessary documentation to support Annual Product Reviews.
• Utilize conflict resolution, problem solving in a cross functional setting, and ability to meet timelines for closure of exception events.
• Management of multiple projects and timelines concurrently.
• Ability to adhere to standard timelines and escalate actions appropriately for resolution in a timely manner.
• Remain current in regulatory expectations and industry practices regarding investigations, CAPAs, and continued process verification.
• Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time event closure.
• 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.
• 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 a scientific discipline with 5+ years of industry experience, of which 2+ years directly support biologic manufacturing (upstream or downstream) or related areas.
• Prior experience in quality investigations and deviation writing in a manufacturing environment is required.
• Manufacturing experience (upstream or downstream) and/or Validation experience is preferred.
• Familiar with FDA and EU regulations and GMP standards. Experience with agency filings and inspections is a plus.
• Prior cGMP cell or gene therapy manufacturing experience is highly desired.
• Ability to work in a matrixed-team environment, meet deadlines, and self-prioritize and balance work from multiple individuals and multiple projects.
• Exceptional verbal and technical writing skills; ability to influence across multiple functions.
• Excellent organizational skills sufficient to multi-task in an extremely fast-paced environment with changing priorities.
• Willingness to take on other tasks as needed to support facility start up.
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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