Process Monitoring Lead, MSAT
Bluebird Bio, Cambridge, MA
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 therapy platforms. The Manufacturing Sciences Data Systems and Analytics (DS&A) organization at bluebird bio is a team of scientists and engineers responsible for the collection, integrity and analysis of manufacturing data of late stage and commercial manufacturing processes for small molecules, oligonucleotides, lentiviral-based vectors and stem and immune cell-based therapies across our network of internal and external manufacturing sites.
The focus of the Process Monitoring Lead role is to drive the Continued Process Verification (CPV) program for the manufacturing processes of one or more commercial assets. This role will be a key contributor to the Data Systems & Analytics group’s mission to provide advanced data analysis and to oversee the implementation and maintenance of effective Statistical Process Control (SPC) programs across the manufacturing network. We seek candidates with a strong technical background and experience in late-stage and/or commercial biopharma manufacturing or development. A proven ability to successfully work both independently and collaboratively to achieve aggressive timelines is required. The successful applicant will play an important role in delivering pioneering gene therapies that can transform the lives of patients with severe genetic diseases or cancer.
About the role:
- Leads the Continued Process Verification (CPV) program for the manufacturing processes of one or more commercial assets
- Provides support to maintain the Statistical Process Control (SPC) program including manufacturing process performance trending, analysis and reporting;
- Build PIMS data hierarchies and process definitions aligned with manufacturing records and process development documentation;
- Author and review manufacturing data-related content of the Annual Product Quality Reviews (APQR);
- Provides data and analysis for regulatory inspections and other interactions with regulatory agencies as required;
- Demonstrates a strong knowledge of cGMP compliance and relevant regulatory agency requirements and guidance;
- Manages the implementation of process changes initiated from the SPC program;
- Support the development of dashboards and automated reporting capabilities for manufacturing process capability assessment;
- Provide support for manufacturing and process investigations through data analysis and support process improvement projects;
- Author and/or review technical documents such as process monitoring plans, SOPs, change controls, investigations, and CAPA;
- Partner with Process Development, MSAT, Manufacturing and Quality teams to identify opportunities for process improvements based on process understanding acquired by trending and end-to-end process capability analysis;
- Work in partnership with bluebird bio’s IT department and system vendors to coordinate troubleshooting, updating and resolution of issues related to PIMS;
- Coordinate training & support to PIMS users as required;
- BS/MS degree in an engineering, or scientific field with relevant experience
- 4+/2+ years of work experience in biotechnology role (e.g. as a CPV lead, Manufacturing specialist, etc.);
- Knowledge of SOPs, cGMPs and experience operating in a GMP manufacturing or development environment;
- Demonstrated experience in biopharma process design, process characterization and/or manufacturing operations;
- Excellent verbal & written communications skills. Interpersonal/facilitation skills necessary to interface with and influence all levels of the organization;
- Demonstrated ability to take initiative, prioritize objectives from multiple projects, and to adhere to scheduled timelines while maintaining flexibility for changes in prioritization;
- Demonstrated problem solving ability, attention to detail, and analytical thinking;
- Experience in statistical analysis is highly desired;
- Experience with the use of and scripting in different software packages like JMP, Minitab is preferred;
- Superb organizational and communications—both written and oral skills—and a “do-what-it-takes” attitude;
- Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view;
- A calling 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.