Associate Manufacturing Specialist II

Company: bluebird bio
Location: Cambridge
Posted on: February 15, 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 and cell therapy approach. This Associate Manufacturing Specialist II will play an integral role in the collaborative management of third party contract manufacturing organizations (CMOs) producing custom lentiviral vector (LVV) products, a critical starting material in our gene therapy platform. This role will focus on both new technology transfers and routine manufacturing. We seek candidates with a proven ability to work independently and collaboratively across Quality Assurance, Quality Control, Process Development, Manufacturing Science and Technology, Supply Chain, and Regulatory functions to ensure manufacturing and release of critical gene therapies that transform the lives of patients. HOW YOU'LL FLY

• Work with the manufacturing operations team to support LVV GMP production at CMOs. Includes all activities from upstream operations through final fill/finish.--
• Author quality system documentation to allow for GMP-grade material release - including change controls, deviations, investigations, and CAPAs.
• Support cross-functional operational meetings to ensure on-time release of LVV
• Participate in the tracking of manufacturing performance metrics and engage in operational excellence initiatives
• Work with supply chain function to ensure the appropriate supply of LVV.
• Support revision and approval of SOPs and batch records as needed.
• Perform Batch Record review and data entry
• Ensure effective flow of communication between all departments involved in production.
• Could involve international travel to CMO (once deemed safe) for up to 25% of a month to oversee end-to-end operations (person-in-plant) and establish collaborative relationships with external partners
• Some weekend work may be needed as necessary to support operations and timelines WHAT YOU'LL BRING
  • BS/MS with 2 - 5 years of experience in cGMP manufacturing in biotech/pharmaceutical cGMP manufacturing industry.
  • Prior cGMP cell/gene therapy or biologics manufacturing experience is highly desirable
  • Experience working with CMOs and/or third party contractors and vendors is highly desirable
  • Strong understanding of cGMP regulations is required.
  • Must be able to work in a team environment, meet deadlines, and prioritize/balance work from multiple individuals (both internal and external to bluebird bio)
  • Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately
  • Independently motivated, detail oriented and good problem-solving ability
  • Strong organizational skills, excels at multi-tasking in an extremely fast-paced environment with changing priorities 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 , Associate Manufacturing Specialist II, Other , Cambridge, Massachusetts