Validation Manager – Bluebird Bio – Cambridge, MA, USA
Join bluebird bio’s enthusiastic and collaborative Validation team to contribute to the overall success of our novel gene therapy. This position will support the organization through the establishment of bluebird bio validation/qualification programs and ensure alignment with industry standards in accordance with the relevant product’s lifecycle. The successful candidate must be able to troubleshoot complex validation issues, and apply advanced validation engineering and scientific principles to the design and implementation of process or system modifications, capital projects, and technology transfer. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success. In this position you will also be responsible for guidance and technical review of protocols and reports related to equipment, test methods, computer systems, technology transfers, process validation, and transport validation activities. These activities will encompass IND-enabling, pre-clinical, clinical and commercial projects. The successful individual will own, lead or support multidisciplinary, multi-site, complex projects.
About the role:
Provide support and guidance for the development, execution, data analysis and reporting of clinical and commercial protocols as necessary.
Provide expertise to technical teams in the implementation of strategies for characterization and validation studies.
Ability to exercise judgment within and outside of defined procedures and practices to determine appropriate action.
Ability to multitask and prioritize independently in a high paced environment.
Complete understanding of industry practices for product lifecycle.
Thorough knowledge and understanding of FDA and European requirements and expectations.
Ensures existing practices comply with industry standards.
Responsible for the alignment of the bluebird validation strategy and content with internal and external clients.
Author risk assessments and validation documentation in close collaboration with internal and external interfaces as necessary.
Provide validation support/expertise to CMC and Technology Transfer teams.
Responsible for supporting the development of process validation requirements for new product introductions through commercial scale.
Support the development of solutions to problems of varying complexity which require a high degree of ingenuity, creativity, and innovativeness.
Contributes to the development of organizational objectives and principles.
Supports the development of long-range goals and objectives.
Exercises considerable latitude in determining objectives and approaches to critical assignments.
Acts as primary contact in absence of management.
Participates in the selection of contract support as necessary.
Provide management support and training to internal contractors.
Wide range of expertise or working knowledge across all validation disciplines including process validation, shipping and cold chain storage, computer systems, method validation, facility utility systems and equipment (FUSE) along with cleaning validation.
Bachelors’ and/or Masters’ degree in Engineering, Biochemistry or related field required. Technical understanding of biopharmaceutical production.
A minimum of eight (8) years of experience in the industry, ideally all clinical phases through commercial drug product.
Knowledge of cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements relevant for process, cleaning and equipment validation.
Experience with Design of Experiments (DOE) approach for process development and characterization.
Prior experience with QbD initiatives and experience writing CMC documents and implementing QbD principles, tools, and processes is also required. Strong understanding of statistics and statistical tools including a track record of hands-on implementation of DOE as it related to QbD is strongly desired.
Leadership skills to lead cross functional teams to ensure project success.
Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project.
Ability to travel approximately 25%.
Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself.
Experience within a multi-product facility and/or Contract Manufacturing Business is a plus.
Validation experience using risk based approach (FMEA, PHA, etc.).
Project management experience.
Strong analytical ability.
Experience with Process Validation; experience with protocol development and execution; experience with presenting documents during inspections (regulatory agencies).
Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
Ability to make independent sound decisions and independently manage priorities in alignment with departmental and corporate goals.