Manufacturing Specialist II, Compliance

ABOUT THE FLOCK

Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. The focus of this position is to provide technical support for on-going external 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.

HOW YOU'LL FLY

You'll help to bring more patients their bluebird days by:

• Being a primary contact for designated external GMP manufacturing runs for ongoing Commercial and Clinical manufacturing carried out by contract manufacturing organizations (CMOs). Work hands on with the CMO to identify and troubleshoot operational issues and coordinate triage of issues and communication of path forward to internal and external teams. Ensure effective flow of communication between all departments involved in manufacturing production.
• Becoming a Subject Matter Expert for the manufacturing process at the CMOs and establish working relationships with external CMOs, both in person and remotely.
• Performing Batch Record review, verification of GMP documentation and corresponding deviation review/management.
• Working Monday-Friday with the ability to be flexible to support European CMOs, supporting manufacturing runs at the completion of onboard training. Travel to CMOs (international) up to 25% -to oversee end-to-end operations (person-in-plant) and establish collaborative relationships with external partners. Travel to bluebird bio headquarters in Sommerville as needed (~1 per month) for team-based activities, workshops, team building, etc.
• Participating in and leading internal and external planning and project specific meetings.
• Owning and driving Deviations, CAPAs and Change Controls from initiation to closure as applicable. Assist in the review of technical documents to provide context for specific events.
• Working closely with Quality Assurance, Quality Control, Manufacturing Science & Technology, and CMOs as applicable for successful manufacturing operations and resolution of Quality System Records. Work closely with internal and external Supply Chains to ensure all materials are available and released for use in Manufacturing.

WHAT YOU'LL BRING

You're the bird we're looking for if you have:

• Preferred BS with 8+ years or MS with 3+ years, or high school diploma with 10+ years of experience in cGMP manufacturing in support of clinical programs and/or commercial products.
• Ability to be flexible in schedule and travel to bbb in Somerville, MA and CMOs in Belgium
• Prior cGMP cell or gene therapy or biologics manufacturing experience for commercial products is highly desirable. Experience working for/with a CMO is also highly desirable.
• Strong understanding of applicable regulations and standards (e.g., GMP). Must be able to review GMP Master Batch Records, deviations, change controls, CAPAS, technical reports and associated GMP documentation.
• Ability to work within ERP/SCM systems for material controls (e.g, Oracle) is highly desirable. Ability to work within quality system management systems for deviations and change controls (e.g., Veeva) is highly desirable.
• Ability 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
• Fluency in English/French is highly desirable

Compensation & Benefits
We offer a total compensation and rewards package that ranks among the best in our industry. Base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The anticipated annualized salary range for this role is $63,552 - $111,556. Your base pay will be determined based on several factors including market data, demonstrated skills, relevant education or training, experience, qualifications, internal equity, and travel requirements. Our overall package also includes eligibility for stock, incentive bonuses, and benefit programs, a flexible time off program, as well as 28 paid holidays, including 2 company shutdowns.