Manufacturing Specialist II
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene and cell therapy approach. The focus of this position is to provide technical support for on-going GMP manufacturing operations for the gene therapy and manufacturing processes. We are looking for an innovative individual with the breadth of experience and drive to implement our vision for this function.
About the role:
- Provide technical support of GMP manufacturing runs for ongoing clinical studies and/or commercial production carried out by contract manufacturing organizations (CMOs)
- Work closely with Quality Assurance and CMOs as applicable for successful resolution of deviations, CAPAs, Change Controls, review of batch records, etc.
- Perform data entry for in-process data for use in tracking and trending data to help drive decision-making and process improvements
- Work with and develop training curricula and module content for CMO personnel
- Serve as person-in-plant for on-going manufacturing, as well as process engineering and/or training runs (as necessary)
- Work with internal stakeholders to support process improvement activities
- Participate in internal planning meetings and interact effectively with cross functional departments
- Up to 20% travel with occasional weekend work
- BS/MS with 4+ years of experience in cGMP manufacturing of clinical and/or commercial products. Some experience in pre-clinical development is also considered relevant
- Prior cGMP manufacturing experience in biologics and/or cell/gene therapies is required
- Experience working with CMO and conducting tech transfers is highly desirable
- Good understanding of applicable regulations and standards (e.g., GMP and AABB)
- Some understanding of and experience with operational excellence, lean management and/or Six Sigma is a plus
- Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals
- 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
- Proficient with timeline development and project tracking using MS Project is a plus
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
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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