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Bluebird Bio

- NASDAQ:BLUE
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# Ticker Symbol Entity Name Domain As Of Date Title URL Brand Category Location Text City State Country Posted Date Number of Openings Description Date Added Date Updated Ticker Sector Ticker Industry
1 nasdaq:blue www.bluebirdbio.com www.bluebirdbio.com Apr 3rd, 2019 12:00AM Associate Manager, Technical Operations Europe Open Patient Operations Zug, Zug, Switzerland Zug CHE Mar 29th, 2019 12:00AM <p><strong>About the role</strong></p> <p>In this role you’ll be responsible for the coordination of treatment with the Treatment Center and Contract Manufacturing Organization, including Order to Cash and distribution management. The role will collaborate with bluebird bio cross-functional teams in Europe and USA including Commercial Operations, Quality Assurance, Finance and the Global Pharmaceutical Science Organization to accomplish bluebird bio’s objectives in Europe for product launch, patient treatment and lifecycle management.</p> <p><strong>Patient scheduling, Treatment Coordination and Operations</strong></p> <ul> <li>Serve as point of contact for the Treatment Center as it relates to patient scheduling and operational execution - supporting Treatment Centers to complete the treatment process through the collection of patient cells, manufacture of drug product and operational execution of treatment</li> <li>Take Treatment Center inquiries and provide Treatment Center support related to the flow of patient cells as part of operational execution</li> <li>Operational management of distribution and logistics as it relates to cold chain shipments of patient cells and bluebird bio product from and to the Treatment Centers throughout Europe</li> <li>Oversee and manage daily supply chain activities for European; which encompasses: order management, customer service, shipment management, sales administrative activities, creation and review of shipping documentation, reporting, Month End Reconciliation</li> <li>Ensure operational execution per the endorsed country physical and financial flows</li> <li>Work closely with Quality organization to ensure GDP compliance</li> <li>Drive enhancements in working with Treatment Centers, the Contract Manufacturing Site and Logistics Providers as it relates to effectiveness, quality of the services and customer experience </li> <li>Roll out of tools and processes to enable effective and smooth operations within bluebird bio and with the Treatment Centers and Contract Manufacturing Organization</li> <li>Subject Matter Expert that manages maintenance and enhancement of ERP System, Tools and processes in corporation with key cross functional stakeholders (e.g. Commercial OPS, Finance, Supply Chain, Planning and Quality)</li> <li>Facilitate effective working relationships with internal customers and external customers</li> <li>Track and communicate key performance indicators</li> <li>Support Project initiatives as required</li> </ul> <p><strong>About you:</strong></p> <ul> <li>Bachelor's degree or Fachhochschule related to Supply Chain</li> <li>Minimum 4 years relevant working experience, preferably in a Logistics/Supply chain role, within the Biotech/Pharmaceutical industry or any other regulated industry such Food/Medical device</li> <li>Experience within an international environment</li> <li>Good understanding of GMPs and GDPs is preferred</li> <li>Experience in managing a customer service or client relations team</li> <li>Approximately 10% travel may be required related to this role</li> <li>Understanding of ERP tools and Order to Cash process</li> <li>Experience with commercial launches and clinical trials is preferred</li> <li>Highly self-motivated individual, with demonstrated ability to work independently in an extremely fast-paced and complex environment.</li> <li>Eligible to work in Switzerland</li> <li>Ready and excited to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself</li> </ul> Apr 3rd, 2019 12:25AM Apr 3rd, 2019 12:25AM Health Care Pharmaceuticals & Biotechnology
2 nasdaq:blue www.bluebirdbio.com www.bluebirdbio.com Apr 2nd, 2019 12:00AM Associate Manager, Technical Operations Europe Open Patient Operations Zug, Zug, Switzerland Zug CHE Mar 29th, 2019 12:00AM <p><strong>About the role</strong></p> <p>In this role you’ll be responsible for the coordination of treatment with the Treatment Center and Contract Manufacturing Organization, including Order to Cash and distribution management. The role will collaborate with bluebird bio cross-functional teams in Europe and USA including Commercial Operations, Quality Assurance, Finance and the Global Pharmaceutical Science Organization to accomplish bluebird bio’s objectives in Europe for product launch, patient treatment and lifecycle management.</p> <p><strong>Patient scheduling, Treatment Coordination and Operations</strong></p> <ul> <li>Serve as point of contact for the Treatment Center as it relates to patient scheduling and operational execution - supporting Treatment Centers to complete the treatment process through the collection of patient cells, manufacture of drug product and operational execution of treatment</li> <li>Take Treatment Center inquiries and provide Treatment Center support related to the flow of patient cells as part of operational execution</li> <li>Operational management of distribution and logistics as it relates to cold chain shipments of patient cells and bluebird bio product from and to the Treatment Centers throughout Europe</li> <li>Oversee and manage daily supply chain activities for European; which encompasses: order management, customer service, shipment management, sales administrative activities, creation and review of shipping documentation, reporting, Month End Reconciliation</li> <li>Ensure operational execution per the endorsed country physical and financial flows</li> <li>Work closely with Quality organization to ensure GDP compliance</li> <li>Drive enhancements in working with Treatment Centers, the Contract Manufacturing Site and Logistics Providers as it relates to effectiveness, quality of the services and customer experience </li> <li>Roll out of tools and processes to enable effective and smooth operations within bluebird bio and with the Treatment Centers and Contract Manufacturing Organization</li> <li>Subject Matter Expert that manages maintenance and enhancement of ERP System, Tools and processes in corporation with key cross functional stakeholders (e.g. Commercial OPS, Finance, Supply Chain, Planning and Quality)</li> <li>Facilitate effective working relationships with internal customers and external customers</li> <li>Track and communicate key performance indicators</li> <li>Support Project initiatives as required</li> </ul> <p><strong>About you:</strong></p> <ul> <li>Bachelor's degree or Fachhochschule related to Supply Chain</li> <li>Minimum 4 years relevant working experience, preferably in a Logistics/Supply chain role, within the Biotech/Pharmaceutical industry or any other regulated industry such Food/Medical device</li> <li>Experience within an international environment</li> <li>Good understanding of GMPs and GDPs is preferred</li> <li>Experience in managing a customer service or client relations team</li> <li>Approximately 10% travel may be required related to this role</li> <li>Understanding of ERP tools and Order to Cash process</li> <li>Experience with commercial launches and clinical trials is preferred</li> <li>Highly self-motivated individual, with demonstrated ability to work independently in an extremely fast-paced and complex environment.</li> <li>Eligible to work in Switzerland</li> <li>Ready and excited to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself</li> </ul> Apr 2nd, 2019 12:25AM Apr 2nd, 2019 12:25AM Health Care Pharmaceuticals & Biotechnology
3 nasdaq:blue www.bluebirdbio.com www.bluebirdbio.com Apr 3rd, 2019 12:00AM Senior Accountant Open Accounting Zug, Zug, Switzerland Zug CHE Mar 29th, 2019 12:00AM <p>Join bluebird bio’s enthusiastic, collaborative, fast-moving and rapidly growing team and contribute to the overall success of our novel gene therapy approach. Based in Zug, Switzerland, this position is designed for an internationally experienced strong team contributor that will play a crucial role in the preparation and reporting of the European financials as well as in implementation of the company’s systems, processes, policies and internal controls for the operations in Europe. The role will take on interesting and challenging responsibilities and projects as our organization continues to grow in both size and complexity, and will serve a critical role in the European Finance organization. This role will report to the Controller Europe. The ideal candidate for this role aspires to grow with the company, is willing to provide support in all areas of the business.</p> <p><strong>About the role:</strong></p> <p><u>Accounting operations, close and financial reporting:</u></p> <ul> <li>Perform monthly, quarterly and yearly US GAAP close activities for several EU entities including preparing and recording journal entries (payroll, accruals, bank reconciliations, prepaid, etc) and performing balance sheet reconciliations.</li> <li>Ensure strong internal controls environment and maintain documentation evidencing SOX 404 compliance</li> <li>Collaborate with US Finance team on accounting and reporting activities</li> <li>Maintain the fixed asset module including adding/disposing of assets, performing monthly depreciation, tagging new assets upon acquisition, and updating monthly reports</li> <li>Perform analytical review of financial results, ad hoc analysis and KPIs reporting</li> </ul> <p> </p> <p><u>Build the European Finance nest</u></p> <ul> <li>Support the design and build of the European Finance function and take on additional responsibilities during build up phase in areas such as Procure to Pay, Order to Cash, Direct and Indirect tax, Intrastat reporting and Treasury</li> <li>Ad hoc projects</li> </ul> <p><u>Financial policies, procedures and processes and internal controls</u></p> <ul> <li>Ensure compliance with laws and policies</li> <li>Partner cross-functionally and cross-regionally in the development and oversight of financial policies and procedures to ensure operational efficiency and scalability for a rapidly growing organization</li> <li>Support evaluation and evolution of financial operations policies and procedures in collaboration with Cambridge Finance team</li> </ul> <p><u>Systems and processes:</u></p> <ul> <li>Support Cambridge Finance team in oversight of financial systems</li> <li>Collaborate with Cambridge teams and external partners to ensure successful development, implementation, improvement and roll-out of financial systems </li> </ul> <p><u>Financial statement filings, audit management and local compliance </u></p> <ul> <li>Prepare information for statutory financial statement and tax returns and support statutory audits</li> <li>Liaise with external accounting and tax providers across Europe</li> <li>Assist with quarterly consolidated audit preparation, as needed</li> <li>Support European Finance interaction with internal and external auditors and local authorities</li> </ul> <p><strong>About you:</strong></p> <ul> <li>Bachelor or Master degree in Accounting or Finance preferred</li> <li>+5 years of experience in an accounting role</li> <li>Big 4 and biotech experience is preferred</li> <li>Advanced financial systems knowledge - Oracle Financials and Blackline is a plus</li> <li>Strong financial analysis and accounting skills, thorough knowledge of US GAAP and/or IFRS accounting principles</li> </ul> <ul> <li>Experience in a growth stage company in an International environment working with outside and remote internal and external resources with tight deadlines.</li> <li>Hands-on and roll-up the sleeves mentality with willingness to take on broad set of responsibilities while the organization is being built up</li> </ul> <ul> <li>Ability to effectively communicate and provide a high level of service to internal and external customers, including all levels within the company</li> <li>Individual must be organized, detail-oriented, proactive, problem solving, self-starting and energetic</li> </ul> <ul> <li>Fluent English. Other main European languages preferred.</li> <li>Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself</li> <li>Eligible to work in Switzerland. No relocation offered.</li> </ul> Apr 3rd, 2019 12:25AM Apr 3rd, 2019 12:25AM Health Care Pharmaceuticals & Biotechnology
4 nasdaq:blue www.bluebirdbio.com www.bluebirdbio.com Apr 2nd, 2019 12:00AM Senior Accountant Open Accounting Zug, Zug, Switzerland Zug CHE Mar 29th, 2019 12:00AM <p>Join bluebird bio’s enthusiastic, collaborative, fast-moving and rapidly growing team and contribute to the overall success of our novel gene therapy approach. Based in Zug, Switzerland, this position is designed for an internationally experienced strong team contributor that will play a crucial role in the preparation and reporting of the European financials as well as in implementation of the company’s systems, processes, policies and internal controls for the operations in Europe. The role will take on interesting and challenging responsibilities and projects as our organization continues to grow in both size and complexity, and will serve a critical role in the European Finance organization. This role will report to the Controller Europe. The ideal candidate for this role aspires to grow with the company, is willing to provide support in all areas of the business.</p> <p><strong>About the role:</strong></p> <p><u>Accounting operations, close and financial reporting:</u></p> <ul> <li>Perform monthly, quarterly and yearly US GAAP close activities for several EU entities including preparing and recording journal entries (payroll, accruals, bank reconciliations, prepaid, etc) and performing balance sheet reconciliations.</li> <li>Ensure strong internal controls environment and maintain documentation evidencing SOX 404 compliance</li> <li>Collaborate with US Finance team on accounting and reporting activities</li> <li>Maintain the fixed asset module including adding/disposing of assets, performing monthly depreciation, tagging new assets upon acquisition, and updating monthly reports</li> <li>Perform analytical review of financial results, ad hoc analysis and KPIs reporting</li> </ul> <p> </p> <p><u>Build the European Finance nest</u></p> <ul> <li>Support the design and build of the European Finance function and take on additional responsibilities during build up phase in areas such as Procure to Pay, Order to Cash, Direct and Indirect tax, Intrastat reporting and Treasury</li> <li>Ad hoc projects</li> </ul> <p><u>Financial policies, procedures and processes and internal controls</u></p> <ul> <li>Ensure compliance with laws and policies</li> <li>Partner cross-functionally and cross-regionally in the development and oversight of financial policies and procedures to ensure operational efficiency and scalability for a rapidly growing organization</li> <li>Support evaluation and evolution of financial operations policies and procedures in collaboration with Cambridge Finance team</li> </ul> <p><u>Systems and processes:</u></p> <ul> <li>Support Cambridge Finance team in oversight of financial systems</li> <li>Collaborate with Cambridge teams and external partners to ensure successful development, implementation, improvement and roll-out of financial systems </li> </ul> <p><u>Financial statement filings, audit management and local compliance </u></p> <ul> <li>Prepare information for statutory financial statement and tax returns and support statutory audits</li> <li>Liaise with external accounting and tax providers across Europe</li> <li>Assist with quarterly consolidated audit preparation, as needed</li> <li>Support European Finance interaction with internal and external auditors and local authorities</li> </ul> <p><strong>About you:</strong></p> <ul> <li>Bachelor or Master degree in Accounting or Finance preferred</li> <li>+5 years of experience in an accounting role</li> <li>Big 4 and biotech experience is preferred</li> <li>Advanced financial systems knowledge - Oracle Financials and Blackline is a plus</li> <li>Strong financial analysis and accounting skills, thorough knowledge of US GAAP and/or IFRS accounting principles</li> </ul> <ul> <li>Experience in a growth stage company in an International environment working with outside and remote internal and external resources with tight deadlines.</li> <li>Hands-on and roll-up the sleeves mentality with willingness to take on broad set of responsibilities while the organization is being built up</li> </ul> <ul> <li>Ability to effectively communicate and provide a high level of service to internal and external customers, including all levels within the company</li> <li>Individual must be organized, detail-oriented, proactive, problem solving, self-starting and energetic</li> </ul> <ul> <li>Fluent English. Other main European languages preferred.</li> <li>Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself</li> <li>Eligible to work in Switzerland. No relocation offered.</li> </ul> Apr 2nd, 2019 12:25AM Apr 2nd, 2019 12:25AM Health Care Pharmaceuticals & Biotechnology
5 nasdaq:blue www.bluebirdbio.com www.bluebirdbio.com Apr 3rd, 2019 12:00AM Treatment Center, Application Engagement Manager, Europe Open IT Zug, Zug, Switzerland Zug CHE Mar 29th, 2019 12:00AM <p>bluebird bio’s Global Information Technology team is on a mission to deliver smart, innovative technology solutions and services to the organization and our patients. ​We move fast here at bluebird, working together as ONE in building a legendary gene therapy company, bringing hope to patients and their families.  As a member of bluebird’s IT team, you'll have the opportunity and privilege to develop technology solutions and services that will support patients, care givers and the healthcare organizations serving them.  We are a passionate, hardworking and friendly flock of IT birds who are looking for individuals to step outside their comfort zone, roll up their sleeves and help us scale this organization to influence the industry of cell and gene therapy, while learning and growing along the way. We invite you to recode for life with us!</p> <p>In this role, you will serve as bluebird bio’s Information Technology Relationship Manager for our patient treatment centers supporting our commercial programs and clinical trials… by fostering and accelerating the support for a new transformational gene therapy model and set of processes that will redefine treatment, patient and family engagement, case management and care as well as the technology infrastructure to support.  The role will proactively provide application services, support and problem resolution for our treatment center users. The position will be based in Zug with responsibility for providing the above tasks for all EU regional offices and Treatment Centers.</p> <p><strong>About the role:</strong> <em> </em></p> <ul> <li>Work closely with bluebird business teams (Engagement, Compliance, Commercial and Patient Operations) to identify and deliver technology solutions for internal and external Treatment Center end users.</li> <li>Collaborate closely with bluebird’s Commercial Treatment Centers and Clinical sites, effectively translating the needs across clinical care and clinical informatics, with real time feedback to internal product/application delivery team.</li> </ul> <ul> <li>Support Treatment Center engagement activities; site administrative, technical and compliance personnel on bluebird’s system requirements; support, collaborate with Treatment Center’s and CMO’s via onsite visits, teleconferences and electronic documentation </li> <li>Actively contribute to various application initiatives (assist in the design, plan, test, execute, support)</li> <li>Support pre-boarding, on-boarding as well as inflight activities for TREATMENT CENTERS’s</li> <li>Install, configure, test, maintain, and troubleshoot end user applications and related hardware.</li> <li>Drive EU implementation of updates to the TREATMENT CENTERS Portal</li> <li>Prepare access and installation of the application for TREATMENT CENTERS’s.</li> <li>Be support for hardware installed at TREATMENT CENTERS’s – provide first level support for incidents reported by TREATMENT CENTERS to call center or directly from TREATMENT CENTERS and escalate incidents if required.</li> <li>Document, track, helpdesk calls and/or escalate issues when necessary. Escalate issues and requests to the IT-Application Team \when appropriate.</li> <li>Build FAQs for Call Center resolution processes</li> </ul> <p><strong>About you:</strong></p> <ul> <li>Experience in Hospitals, Life Sciences or Healthcare industries working with, supporting clinicians and staff a must</li> <li>Strong IT systems background, well versed in application design functionality from a user experience perspective, (clinical portal, patient case mgmt. and patient cell traceability) of the systems we will be training the sites to use;  setup and support and is an active, listening partner to our gene therapy account managers and site personnel on issues, improvements, requests for new functionality to our systems.</li> <li>3 - 5 years of experience system implementation and support of Salesforce, Veeva CRM platforms Oracle ERP,  Office 365 and Sharepoint.</li> <li>Bachelor’s degree or equivalent experience, and 1-3 years of end user support working within helpdesk Applications including, ticket escalation and reporting</li> <li>Excellent communication, customer relation and problem-solving skills a must.</li> <li>Experience with providing external customer support</li> <li>Ability to work autonomously on various problems and be willing and able to take on new responsibilities as needed.</li> <li>Fluent in English and German, additional languages will be an advantage</li> <li>Ability to execute and follow-through to completion and documentation.</li> </ul> <ul> <li>Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.</li> <li>Independently motivated, detail oriented and good problem solving ability.</li> <li>Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.</li> <li>Excellent communication skills and ability to influence across multiple functions</li> <li>Eligible to work in Switzerland</li> <li>Be ready to embrace the principles of the bluebird bio culture: <strong><em>b colorful, b cooperative, and b yourself</em></strong></li> </ul> Apr 3rd, 2019 12:25AM Apr 3rd, 2019 12:25AM Health Care Pharmaceuticals & Biotechnology
6 nasdaq:blue www.bluebirdbio.com www.bluebirdbio.com Apr 2nd, 2019 12:00AM Treatment Center, Application Engagement Manager, Europe Open IT Zug, Zug, Switzerland Zug CHE Mar 29th, 2019 12:00AM <p>bluebird bio’s Global Information Technology team is on a mission to deliver smart, innovative technology solutions and services to the organization and our patients. ​We move fast here at bluebird, working together as ONE in building a legendary gene therapy company, bringing hope to patients and their families.  As a member of bluebird’s IT team, you'll have the opportunity and privilege to develop technology solutions and services that will support patients, care givers and the healthcare organizations serving them.  We are a passionate, hardworking and friendly flock of IT birds who are looking for individuals to step outside their comfort zone, roll up their sleeves and help us scale this organization to influence the industry of cell and gene therapy, while learning and growing along the way. We invite you to recode for life with us!</p> <p>In this role, you will serve as bluebird bio’s Information Technology Relationship Manager for our patient treatment centers supporting our commercial programs and clinical trials… by fostering and accelerating the support for a new transformational gene therapy model and set of processes that will redefine treatment, patient and family engagement, case management and care as well as the technology infrastructure to support.  The role will proactively provide application services, support and problem resolution for our treatment center users. The position will be based in Zug with responsibility for providing the above tasks for all EU regional offices and Treatment Centers.</p> <p><strong>About the role:</strong> <em> </em></p> <ul> <li>Work closely with bluebird business teams (Engagement, Compliance, Commercial and Patient Operations) to identify and deliver technology solutions for internal and external Treatment Center end users.</li> <li>Collaborate closely with bluebird’s Commercial Treatment Centers and Clinical sites, effectively translating the needs across clinical care and clinical informatics, with real time feedback to internal product/application delivery team.</li> </ul> <ul> <li>Support Treatment Center engagement activities; site administrative, technical and compliance personnel on bluebird’s system requirements; support, collaborate with Treatment Center’s and CMO’s via onsite visits, teleconferences and electronic documentation </li> <li>Actively contribute to various application initiatives (assist in the design, plan, test, execute, support)</li> <li>Support pre-boarding, on-boarding as well as inflight activities for TREATMENT CENTERS’s</li> <li>Install, configure, test, maintain, and troubleshoot end user applications and related hardware.</li> <li>Drive EU implementation of updates to the TREATMENT CENTERS Portal</li> <li>Prepare access and installation of the application for TREATMENT CENTERS’s.</li> <li>Be support for hardware installed at TREATMENT CENTERS’s – provide first level support for incidents reported by TREATMENT CENTERS to call center or directly from TREATMENT CENTERS and escalate incidents if required.</li> <li>Document, track, helpdesk calls and/or escalate issues when necessary. Escalate issues and requests to the IT-Application Team \when appropriate.</li> <li>Build FAQs for Call Center resolution processes</li> </ul> <p><strong>About you:</strong></p> <ul> <li>Experience in Hospitals, Life Sciences or Healthcare industries working with, supporting clinicians and staff a must</li> <li>Strong IT systems background, well versed in application design functionality from a user experience perspective, (clinical portal, patient case mgmt. and patient cell traceability) of the systems we will be training the sites to use;  setup and support and is an active, listening partner to our gene therapy account managers and site personnel on issues, improvements, requests for new functionality to our systems.</li> <li>3 - 5 years of experience system implementation and support of Salesforce, Veeva CRM platforms Oracle ERP,  Office 365 and Sharepoint.</li> <li>Bachelor’s degree or equivalent experience, and 1-3 years of end user support working within helpdesk Applications including, ticket escalation and reporting</li> <li>Excellent communication, customer relation and problem-solving skills a must.</li> <li>Experience with providing external customer support</li> <li>Ability to work autonomously on various problems and be willing and able to take on new responsibilities as needed.</li> <li>Fluent in English and German, additional languages will be an advantage</li> <li>Ability to execute and follow-through to completion and documentation.</li> </ul> <ul> <li>Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.</li> <li>Independently motivated, detail oriented and good problem solving ability.</li> <li>Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.</li> <li>Excellent communication skills and ability to influence across multiple functions</li> <li>Eligible to work in Switzerland</li> <li>Be ready to embrace the principles of the bluebird bio culture: <strong><em>b colorful, b cooperative, and b yourself</em></strong></li> </ul> Apr 2nd, 2019 12:25AM Apr 2nd, 2019 12:25AM Health Care Pharmaceuticals & Biotechnology
7 nasdaq:blue www.bluebirdbio.com www.bluebirdbio.com Apr 3rd, 2019 12:00AM Associate Director, Regulatory Science - CMC, Severe Genetic Disease Open Regulatory Zug, Zug, Switzerland Zug CHE Mar 29th, 2019 12:00AM <p>bluebird bio’s Regulatory Science team is focused on the efficient development of our gene therapy products to bring safe and efficacious products to the market to improve, and hopefully transform, patients’ lives.  We have a lot of work to do across our Severe Genetic Diseases Franchise and our Oncology Franchise.  Patients are waiting and we know we are making a difference every day when we show-up to the nest!</p> <p>As Regulatory Science team member, you will work with (*surprise*) the FDA and the EMA, as well as national regulatory authorities globally, thinking out of the box and finding innovative ways to improve Regulatory Science.  We see regulators as partners.  Our core principles are to be transparent and proactive in our communication with them and to use science-based reasoning.  Gene therapy is innovative and so are the regulatory birds!  If you’re interested in pioneering gene therapy with purpose, come fly with us!</p> <p>In this position you will be responsible for the development of innovative CMC regulatory strategies in ATMP life cycle management and the preparation and submission of high quality CMC variation dossiers, in close collaboration with Regulatory Science colleagues, in-house Pharmaceutical Sciences and Quality teams, contract manufacturing organizations, external experts and global health authorities.</p> <p><strong>About the role:</strong><strong> </strong></p> <ul> <li>Manage post-approval CMC Regulatory activities and timelines, including major and strategic variations in the European Union (EU) for bluebird bio’s gene therapy ATMPs</li> <li>Manage and implement planning, preparation and submission of high-quality CMC modules of initial marketing authorization applications in the EU and a limited number of countries outside of the EU.</li> <li>Ensure that CMC-related applications and/or sections, including variation dossiers and initial applications are complete, well written, and meet all relevant requirements</li> <li>Participate in negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators; prepare and submit responses to CMC questions</li> <li>Drive adherence to CMC regulatory guidelines relevant for the development of gene therapy products; review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals</li> <li>Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation</li> <li>Partner with Pharmaceutical Sciences, Quality, Nonclinical, Clinical and Regulatory Science Project Leads to ensure achievement of submission deadlines and obtain timely approvals of bluebird bio CMC‑related applications</li> <li>Participate as needed in interactions with regulatory agencies during GMP and pre-approval inspections, in partnership with bluebird bio’s European and global Quality Assurance team</li> <li>Participate in regulatory intelligence activities; monitor regulatory guidelines and trends; obtain and interpret global CMC regulations and guidance and provide regulatory advice to bluebird bio in-house CMC teams and Project/Product teams</li> </ul> <p><strong>About you: </strong><strong> </strong></p> <ul> <li>Master’s degree in biochemistry, chemistry, biology or related pharmaceutical fields including chemical engineering required; PhD degree desirable</li> <li>Minimum 6 years of relevant bio pharmaceutical industry experience with at least 4 years of experience in CMC‐focused Regulatory Affairs for biologics and preferably for ATMPs. Experience should encompass post-approval regulatory dossier life-cycle management.</li> <li>Excellent written and oral communication, including CMC regulatory writing; an ability to pay attention to and communicate details; ability to influence across multiple functions</li> <li>Strong knowledge of current Good Manufacturing Practices (GMP), experience with on-site health authority inspections desirable</li> <li>Strong leadership qualities including strategic thinking, innovation, mentoring, scaling, collaboration, etc.</li> <li>Independently motivated, detail oriented and good problem-solving ability</li> <li>Ability to work both independently and collaboratively in a team structure and thrive in a fast-paced, multi-task environment; demonstrated ability to work well under pressure</li> <li>Eligible to work in Switzerland</li> <li>Be ready to embrace the principles of the bluebird bio culture: <em>b colorful, b cooperative, and b yourself</em></li> </ul> Apr 3rd, 2019 12:25AM Apr 3rd, 2019 12:25AM Health Care Pharmaceuticals & Biotechnology
8 nasdaq:blue www.bluebirdbio.com www.bluebirdbio.com Apr 2nd, 2019 12:00AM Associate Director, Regulatory Science - CMC, Severe Genetic Disease Open Regulatory Zug, Zug, Switzerland Zug CHE Mar 29th, 2019 12:00AM <p>bluebird bio’s Regulatory Science team is focused on the efficient development of our gene therapy products to bring safe and efficacious products to the market to improve, and hopefully transform, patients’ lives.  We have a lot of work to do across our Severe Genetic Diseases Franchise and our Oncology Franchise.  Patients are waiting and we know we are making a difference every day when we show-up to the nest!</p> <p>As Regulatory Science team member, you will work with (*surprise*) the FDA and the EMA, as well as national regulatory authorities globally, thinking out of the box and finding innovative ways to improve Regulatory Science.  We see regulators as partners.  Our core principles are to be transparent and proactive in our communication with them and to use science-based reasoning.  Gene therapy is innovative and so are the regulatory birds!  If you’re interested in pioneering gene therapy with purpose, come fly with us!</p> <p>In this position you will be responsible for the development of innovative CMC regulatory strategies in ATMP life cycle management and the preparation and submission of high quality CMC variation dossiers, in close collaboration with Regulatory Science colleagues, in-house Pharmaceutical Sciences and Quality teams, contract manufacturing organizations, external experts and global health authorities.</p> <p><strong>About the role:</strong><strong> </strong></p> <ul> <li>Manage post-approval CMC Regulatory activities and timelines, including major and strategic variations in the European Union (EU) for bluebird bio’s gene therapy ATMPs</li> <li>Manage and implement planning, preparation and submission of high-quality CMC modules of initial marketing authorization applications in the EU and a limited number of countries outside of the EU.</li> <li>Ensure that CMC-related applications and/or sections, including variation dossiers and initial applications are complete, well written, and meet all relevant requirements</li> <li>Participate in negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators; prepare and submit responses to CMC questions</li> <li>Drive adherence to CMC regulatory guidelines relevant for the development of gene therapy products; review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals</li> <li>Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation</li> <li>Partner with Pharmaceutical Sciences, Quality, Nonclinical, Clinical and Regulatory Science Project Leads to ensure achievement of submission deadlines and obtain timely approvals of bluebird bio CMC‑related applications</li> <li>Participate as needed in interactions with regulatory agencies during GMP and pre-approval inspections, in partnership with bluebird bio’s European and global Quality Assurance team</li> <li>Participate in regulatory intelligence activities; monitor regulatory guidelines and trends; obtain and interpret global CMC regulations and guidance and provide regulatory advice to bluebird bio in-house CMC teams and Project/Product teams</li> </ul> <p><strong>About you: </strong><strong> </strong></p> <ul> <li>Master’s degree in biochemistry, chemistry, biology or related pharmaceutical fields including chemical engineering required; PhD degree desirable</li> <li>Minimum 6 years of relevant bio pharmaceutical industry experience with at least 4 years of experience in CMC‐focused Regulatory Affairs for biologics and preferably for ATMPs. Experience should encompass post-approval regulatory dossier life-cycle management.</li> <li>Excellent written and oral communication, including CMC regulatory writing; an ability to pay attention to and communicate details; ability to influence across multiple functions</li> <li>Strong knowledge of current Good Manufacturing Practices (GMP), experience with on-site health authority inspections desirable</li> <li>Strong leadership qualities including strategic thinking, innovation, mentoring, scaling, collaboration, etc.</li> <li>Independently motivated, detail oriented and good problem-solving ability</li> <li>Ability to work both independently and collaboratively in a team structure and thrive in a fast-paced, multi-task environment; demonstrated ability to work well under pressure</li> <li>Eligible to work in Switzerland</li> <li>Be ready to embrace the principles of the bluebird bio culture: <em>b colorful, b cooperative, and b yourself</em></li> </ul> Apr 2nd, 2019 12:25AM Apr 2nd, 2019 12:25AM Health Care Pharmaceuticals & Biotechnology
9 nasdaq:blue www.bluebirdbio.com www.bluebirdbio.com Apr 3rd, 2019 12:00AM Manager, Regulatory Science, Severe Genetic Disease Open Regulatory Zug, Zug, Switzerland Zug CHE Mar 29th, 2019 12:00AM <p>bluebird bio’s Regulatory Science team is focused on the efficient development of our gene therapy products to bring safe and efficacious products to the market to improve, and hopefully transform, patients’ lives.  We have a lot of work to do across our Severe Genetic Diseases Franchise and our Oncology Franchise.  Patients are waiting and we know we are making a difference every day when we show-up to the nest!</p> <p>As Regulatory Science team member, you will work with (*surprise*) the FDA and the EMA, as well as national regulatory authorities globally, thinking out of the box and finding innovative ways to improve Regulatory Science.  We see regulators as partners.  Our core principles are to be transparent and proactive in our communication with them and to use science-based reasoning.  Gene therapy is innovative and so are the regulatory birds!  If you’re interested in pioneering gene therapy with purpose, come fly with us!</p> <p>We seek an experienced Regulatory Science professional who will be responsible for the supporting European Marketing Authorisation (EMA) applications and post-marketing variations, as well as supporting expansion into non-EU markets.</p> <h4>About the position:</h4> <ul> <li>Collaborate with regulatory science and cross-functional colleagues on the preparation and submission of regulatory filings, including major marketing applications, major and routine post-marketing changes and Clinical Trial Applications/INDs; this will require cross-functional interactions, excellent project management and writing skills, as well as a good understanding of the underlying science</li> <li>Act as regulatory submission lead for non-EU markets pre- and post-MA to compile high quality submissions in accordance with the global regulatory strategy, in collaboration with external vendors and internal stakeholders</li> <li>Prepare submissions plans and manage timelines for regulatory submissions</li> <li>Work closely with commercial team to support regulatory deliverables for launch in EU and non-EU markets</li> <li>Prepare and review sections of regional regulatory submissions to optimise product development (e.g. Orphan Drug, Paediatric Investigation Plans, protocol assistance, etc.)</li> <li>Support interactions with regulatory agencies to resolve issues, and prepare and submit responses to questions</li> <li>Manage regulatory documentation and submission logs</li> <li>Review technical documentation and regulatory documents to ensure conformance with applicable regulatory guidelines, including cell and gene therapy guidelines, internal style guidelines and requirements including SOPs</li> <li>Assist team during regulatory agency inspections</li> <li>Participate in regulatory intelligence activities; monitor regulatory guidelines and trends</li> </ul> <h4>About you: </h4> <ul> <li>Advanced degree in biochemistry, chemistry, biology, pharmacy, or related pharmaceutical fields including bio-chemical engineering</li> <li>Minimum 3+ years of regulatory experience in a biotech/pharma company or consultancy, preferably in biologics</li> <li>Experience with regulatory writing and compiling submissions</li> <li>Experience in rare diseases and/or cell and gene therapies and/or innovative biologics products</li> <li>Experience of non-EU markets is a plus</li> <li>Knowledgeable in ICH and EMA guidelines</li> <li>Knowledge of Good Clinical Practice and current Good Manufacturing Practices (GMP) preferred</li> <li>Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view</li> <li>Independently motivated, detail-oriented and good problem-solving ability</li> <li>Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities</li> <li>Excellent communication skills and ability to influence across multiple functions</li> <li>Eligible to work in Switzerland</li> <li>Be ready to embrace the principles of the bluebird bio culture: <em>b colourful, b cooperative, and b yourself</em></li> </ul> Apr 3rd, 2019 12:25AM Apr 3rd, 2019 12:25AM Health Care Pharmaceuticals & Biotechnology
10 nasdaq:blue www.bluebirdbio.com www.bluebirdbio.com Apr 2nd, 2019 12:00AM Manager, Regulatory Science, Severe Genetic Disease Open Regulatory Zug, Zug, Switzerland Zug CHE Mar 29th, 2019 12:00AM <p>bluebird bio’s Regulatory Science team is focused on the efficient development of our gene therapy products to bring safe and efficacious products to the market to improve, and hopefully transform, patients’ lives.  We have a lot of work to do across our Severe Genetic Diseases Franchise and our Oncology Franchise.  Patients are waiting and we know we are making a difference every day when we show-up to the nest!</p> <p>As Regulatory Science team member, you will work with (*surprise*) the FDA and the EMA, as well as national regulatory authorities globally, thinking out of the box and finding innovative ways to improve Regulatory Science.  We see regulators as partners.  Our core principles are to be transparent and proactive in our communication with them and to use science-based reasoning.  Gene therapy is innovative and so are the regulatory birds!  If you’re interested in pioneering gene therapy with purpose, come fly with us!</p> <p>We seek an experienced Regulatory Science professional who will be responsible for the supporting European Marketing Authorisation (EMA) applications and post-marketing variations, as well as supporting expansion into non-EU markets.</p> <h4>About the position:</h4> <ul> <li>Collaborate with regulatory science and cross-functional colleagues on the preparation and submission of regulatory filings, including major marketing applications, major and routine post-marketing changes and Clinical Trial Applications/INDs; this will require cross-functional interactions, excellent project management and writing skills, as well as a good understanding of the underlying science</li> <li>Act as regulatory submission lead for non-EU markets pre- and post-MA to compile high quality submissions in accordance with the global regulatory strategy, in collaboration with external vendors and internal stakeholders</li> <li>Prepare submissions plans and manage timelines for regulatory submissions</li> <li>Work closely with commercial team to support regulatory deliverables for launch in EU and non-EU markets</li> <li>Prepare and review sections of regional regulatory submissions to optimise product development (e.g. Orphan Drug, Paediatric Investigation Plans, protocol assistance, etc.)</li> <li>Support interactions with regulatory agencies to resolve issues, and prepare and submit responses to questions</li> <li>Manage regulatory documentation and submission logs</li> <li>Review technical documentation and regulatory documents to ensure conformance with applicable regulatory guidelines, including cell and gene therapy guidelines, internal style guidelines and requirements including SOPs</li> <li>Assist team during regulatory agency inspections</li> <li>Participate in regulatory intelligence activities; monitor regulatory guidelines and trends</li> </ul> <h4>About you: </h4> <ul> <li>Advanced degree in biochemistry, chemistry, biology, pharmacy, or related pharmaceutical fields including bio-chemical engineering</li> <li>Minimum 3+ years of regulatory experience in a biotech/pharma company or consultancy, preferably in biologics</li> <li>Experience with regulatory writing and compiling submissions</li> <li>Experience in rare diseases and/or cell and gene therapies and/or innovative biologics products</li> <li>Experience of non-EU markets is a plus</li> <li>Knowledgeable in ICH and EMA guidelines</li> <li>Knowledge of Good Clinical Practice and current Good Manufacturing Practices (GMP) preferred</li> <li>Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view</li> <li>Independently motivated, detail-oriented and good problem-solving ability</li> <li>Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities</li> <li>Excellent communication skills and ability to influence across multiple functions</li> <li>Eligible to work in Switzerland</li> <li>Be ready to embrace the principles of the bluebird bio culture: <em>b colourful, b cooperative, and b yourself</em></li> </ul> Apr 2nd, 2019 12:25AM Apr 2nd, 2019 12:25AM Health Care Pharmaceuticals & Biotechnology

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