On January 11, 2021, we announced our intent to separate our severe genetic disease and oncology businesses into differentiated and independent publicly traded companies. We will retain focus on severe genetic disease (SGD) and will launch our oncology business (Oncology Newco) as a new entity, with the completed transition expected by the end of 2021.About The Nest
At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. Were 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.
About The Flock
The Senior Manager, Microbiology, will provide Microbiology and contamination control expertise and oversight to bluebird bio contract manufacturing organizations (CMO) for lentiviral vector (LVV) and drug product. The Senior Manager will develop, document, and manage microbial control strategies for lentiviral vector and drug product production processes; perform microbial risk assessments; serve as SME on tech transfer teams; ensure sterility assurance of low bioburden and sterile manufactured products, harmonize microbiology requirements and testing approaches across CMOs; work with QC method development teams at bbb for support of microbial methods; provide microbiological expertise for the drafting and review of cGMP documents. Additionally, the Senior Manager will support the organization by ensuring conformance to established quality processes and standards while actively working to continuously improve them.
How Youll Fly
As Quality Assurance bird, you'll help to bring more patients their bluebird days by:
What Youll Bring
- Develop and implement bluebird bio microbial control strategy including effective contamination control oversight at CMOs, harmonization of microbial strategies across bluebird bio CMOs and contract testing organizations (CTOs)
- Provide Subject Matter Expertise (SME) input for Environmental Monitoring and Contamination Control Programs implemented at bluebird bio CMOs and CTOs
- Provide SME input for bluebird bios microbiology strategy and policies related to Contamination Control of externally manufactured bluebird bio products
- Perform microbial risk assessments (HACCP/FMEA/LOPA, ) as the microbiology SME and risk owner
- Provide microbial SME support of microbial investigations, OOS, deviations and CAPAs reported by CMO/CTO
- Partner with QA, MSAT, Manufacturing and PD on tech transfer and support of external manufacturing and serve as Microbiology SME with cross-functional teams
- Interface with QA to manage supplier microbial issues and participate in vendor audits, as needed
- Author, review, and/or approve SOPs, policies, risk assessments, and technical reports
- Review and provide, as needed, support authoring of regulatory submissions on Micro and Contamination Control.
Youre the bird were looking for if you:
- BS or MS in Microbiology, Biology or other related field
- 10 - 15+ years of related experience within the biopharmaceutical industry with direct, relevant Microbiology experience
- 5+ years of supervisory experience desired
- Demonstrate knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP and JP monographs for microbiology
- Strong knowledge of microbiological and sterility testing, media fills, environmental monitoring, clean room qualification and management, quality control endotoxin testing and microbiological control strategy required
- Experience with risk assessments; Experience with oversight of aseptic processing and the associated international aseptic processing regulations are required
- Ability to work in a fast-paced environment, team oriented, independent work skills and a strong work ethic
- Ability to interface and communicate directly with CMO/CTOs
- Ability to travel to domestic and international CMO/CTOs 30%
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.