ABOUT THE FLOCK

This role encompasses day-to-day management of drug product manufacturing deliverables in support of a CMO to support one of bluebird’s three commercial drug products. You will lead a team of manufacturing specialists who support commercial drug product manufacturing through direct on-site support as well as remote support. You will also function as a key leader of a cross-functional internal team and as a key leader on behalf of manufacturing with the external CMO team.

HOW YOU’LL FLY

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

• Working with the manufacturing operations and cross-functional teams to support GMP production at a CMO partner.
• Evaluating and driving a continuous improvement and operational excellence culture through performance management of KPIs (key performance indicators).
• Being accountable for the performance and results of the assigned CMO.
• Leading internal and external working team meetings to resolve complex manufacturing issues and delays at the CMO that could have a broad impact on the business.
• Driving the development and execution of projects (potentially including tech transfers, PPQ campaigns, regulatory inspections and post-approval changes) through effective use of leadership attributes, project management & OE tools.
• Owning and driving batch record reviews and quality systems (change control, deviation, CAPA), as needed.
• Providing the technical manufacturing expertise for technical reports and regulatory submissions, as needed.

WHAT YOU’LL BRING

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

• Degree in Engineering or Life Sciences (BS/8 years or MS/6 years) or no degree/10 years relevant industry experience
• People-management experience (required). Experience leading a cross-functional team is preferred.
• Strong understanding of cGMPs in a gene therapy, cell therapy and/or biologics role is required
• Must be highly organized and detail oriented
• Exceptional verbal communication skills and an ability to influence across multiple functions and levels of an organization
• Ability to escalate and communicate barriers to success and be able to propose effective solutions

Travel: Travel to the CMO site in New Jersey regularly (3-4 days per week) for the first 6 months in role at a minimum, and travel once a month to our headquarters in Boston.

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 $160,000-$170,000. 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 paid holidays, bluebird days, and a holiday shutdown in December.