Novel gene therapy platform
With our lentiviral-based gene therapy and gene editing capabilities, we have built an integrated product platform with broad potential application to severe genetic diseases and T cell-based immunotherapy. Our clinical programs include Lenti-D™, currently in a Phase 2/3 study, called the Starbeam Study, for the treatment of childhood cerebral adrenoleukodystrophy, and LentiGlobin®, currently in three clinical studies: a global Phase 1/2 study, called the Northstar Study, for the treatment of beta-thalassemia major; a single-center Phase 1/2 study in France (HGB-205) for the treatment of beta-thalassemia major or severe sickle cell disease; and a separate U.S. Phase 1 study for the treatment of sickle cell disease (HGB-206). We also have ongoing preclinical CAR T immuno-oncology programs, as well as discovery research programs utilizing megaTAL/homing endonuclease gene editing technologies.
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 support the growth of the Supply Chain team by leading build of processes and standards related to the identification, evaluation, selection and management of bluebird bio related supply chain vendors. We are looking for an innovative professional with the breadth of experience and drive to implement our vision for this function and work collaboratively with both internal and external partners.
About the role:
- Develop vendor management process including vendor categories and classification, category analysis, as well as the development and tracking of vendor scorecard focusing on cost, quality, delivery, customer satisfaction, continuous improvement, and sustainability.
- Develop and categorize vendors, establish a management processes including risk assessment and management, business requirements, contracting, scorecard and performance management.
- Responsible for the vendor sourcing process including market research, value analysis, bidding, and contracting.
- Lead/support teams within Pharmaceutical sciences in developing/finalizing contracts/agreements including Confidentiality Agreements, Master Services Agreements, Work Orders, Change Orders and amendments.
- Ensure terms and conditions of supply agreements are adhered, executed and documented, such as timely execution of changes and close monitoring of contract performance.
- Establish and foster effective strategic vendor relationships; develop risk assessment and mitigation plan for critical vendors, escalate business risks to proper level of management.
- Function as a project lead and liaison between internal bluebird bio functions such as Supplier Quality, Manufacturing Operations, Supply Chain, Procurement, IT, Legal and Finance related to change management, coordination of vendor investigations, vendor initiated changes, vendor qualification and periodic performance review.
- Collaborate and build productive relationships with internal business partners and stakeholders to enable timely fulfillment of business requirements.
- Assist Quality units in vendor audits, investigations, complaints, change control and GMP systems monitoring, and follow up on implementation of corrective actions.
- Continuous business process improvements (e.g., enhancements to the sourcing process, development or revision of key sourcing procedures, documenting processes, risk assessment, etc.).
- Bachelor's degree or a combination of education and business experience required - advanced degree preferred (e.g. MBA etc.).
- Minimum 10+ years of life sciences or related experience in biotech and/or pharmaceutical industry (supply chain, vendor management, strategic sourcing and/or management of GMP material/service provider experience preferred)
- Experience in partnering, supplier quality, continuous improvement, influencing at all levels of the organization, collaboration and cross-functional team leadership
- Strong knowledge of GMP, SOPs and quality processes is necessary, along with a firm understanding of the Quality Assurance systems, as well as Quality audit, and supplier qualification program
- Demonstrated business acumen and experience in contract negotiation/administration, with the ability to draw insights from data quickly, perform analysis and present business cases
- Comfortable in a fast-paced small company environment with minimal direction with the ability to adjust workload based upon changing priorities
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
- Collaborates well in cross-functional matrix environment, ability to communicate and work independently with scientific/technical personnel
- Critical thinker with demonstrated troubleshooting and problem solving skills
- Outstanding strategic skills with the ability to transform general goals into actionable plans
- Excellent analytical, interpersonal, verbal and written communication skills
- Proficient in MS Word, Excel, Power Point and other applications
bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.
Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.