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Career postings for the Massachusetts Biotechnology Council

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  • 12/16/15--09:42: Quality Control Scientist
  • Our “A” level research group located in the biopharma hotbed of the nation is looking for a talented QC scientist.  If you have the ability to work effectively in a collaborative team environment, see how your expertise can have an impact using cutting edge gene therapy.  This amazing opportunity is looking for someone who also meets the following requirements:

    • BA / BS with approx. 2-5 years of industry experience in QC GMP environment with exposure to biologics programs
    • Strong working knowledge of cGMP/ICH/FDA/EU regulations
    • Experience with cell culture, qPCR, Flow Cytometry
    • History of compiling and verifying data in the CMC sections of regulatory filings
    • Experience with external vendors
    • Excellent organizational and communication skills working across many levels

    About StratAcuity
    Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

    CHEMISTRY IS EVERYTHING™


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  • 12/15/15--22:09: IT/Systems Administrator
  • IT/System Administrator


    Ginkgo Bioworks is YCombinator's first biotech company ... we were personally recruited by Sam Altman to join YC: http://techcrunch.com/2014/08/19/sam-altman-on-his-inaugural-batch-of-companies-as-y-combinators-new-head/

    Our mission is to make biology easier to engineer. We engineer organisms to address fundamental challenges the world is facing today. Ginkgo bioengineers make use of an in-house organism foundry to engineer new organisms for making natural products, pharmaceuticals, biofuels, and more. We're making the code base, compiler and debugger for life.

    We're looking for a system administrator/devop/help desk engineer to support us as we scale our company. You'll be working hand in hand with biological engineers and software developers to ensure the uptime, reliability, and throughput of our organism foundry.


    RESPONSIBILITY
    * Design and implement security and backup strategies
    * Manage all wired and wireless networks
    * Build and manage production server hardware and software
    * Provide input on optimizing software development and deployment
    * Maintain uptime and performance of all aspects of our foundry
    * Manage interfacing with lab resources
    * Support developers and scientists in their IT needs
    * Repair and upgrade hardware and software as necessary
    * Prepare and implement backups and disaster recovery plans
    * Provide end user training and desktop support


    REQUIREMENTS
    * 3+ years of IT experience
    * Be a generalist and handle everything IT related
    * Ability to write scripts in your sleep
    * Extremely comfortable working with Linux servers and container technology
    * Fluency with other major platforms: Windows, OS X
    * Experience with sysadmin, devops, and network management
    To learn more about Ginkgo, check out some recent press:

    http://www.wired.com/2015/11/move-over-jony-ivebiologists-are-the-next-rock-star-designers/

    http://fortune.com/2015/07/23/ginkgo-bioworks/

    https://medium.com/the-os-fund/a-new-era-of-industrial-engineering-using-biology-dd4571aa6d27

    We also feel it’s important to point out the obvious here – there’s a serious lack of diversity in our industry and it needs to change. Our goal is to help drive that change. We hope to continue to build a company whose culture promotes inclusion and embraces how rewarding it is to work with engineers from all walks of life. Making biology easier to engineer is a tough nut to crack - we can’t afford to leave any talent untapped.

    It is the policy of Ginkgo Bioworks to provide equal employment opportunities to all employees and employment applicants.


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    We are passionate about engineering organisms at Ginkgo Bioworks. We're guessing you are too.

    We believe that engineering organisms requires an integrated, industrialized technology pipeline. Over the past few years that's what we've been building at Ginkgo. Our first foundry Bioworks1 includes robotic automation, novel DNA assembly biochemistry, custom CAD/CAM software, high resolution LC-MS, and much more. We built it for people like you.

    You have experience in rational design of genetic systems, but also understand the benefits of mutation and evolution in building better strains. You're excited to work with both software developers and organism engineers to develop real design principles for biology. You have insight into leveraging high-throughput DNA synthesis to design effective screens and selections.

    Take a look at the following statements -

    * You are a student of other engineering fields and look for lessons for engineering biology

    * You think that computers are a bad metaphor for a cell

    * You recognize that biology is a unique engineering substrate that comes pre-loaded with startlingly brilliant code we didn't write

    * You think most people engineering organisms are undisciplined in their approach

    * You recognize that we are at the beginning of engineering organisms and that there will never be another chance like this to define the field.

    If these statements describe you well and you feel up to the challenging position described above, perhaps you should apply to Ginkgo Bioworks.

    REQUIREMENTS

    • Ph.D. or equivalent
    • Previous success engineering at least one organism - plants, fish, microbes, worms, fungi ... it doesn't matter, as long as it worked.
    • Few years post-graduate experience with a second organism a plus.

    To learn more about Ginkgo, check us out on Medium and BuzzFeed

    https://medium.com/the-os-fund/a-new-era-of-industrial-engineering-using-biology-dd4571aa6d27

    http://www.buzzfeed.com/stephaniemlee/this-startup-is-designing-yeast-to-make-brand-new-scents-fla#.ph2jnprJK

    We also feel it’s important to point out the obvious here – there’s a serious lack of diversity in our industry and it needs to change. Our goal is to help drive that change. We hope to continue to build a company whose culture promotes inclusion and embraces how rewarding it is to work with engineers from all walks of life. Making biology easier to engineer is a tough nut to crack - we can’t afford to leave any talent untapped.

     

    www.ginkgobioworks.com 


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  • 12/15/15--22:19: Senior Genome Engineer
  • Ginkgo is building an industrialized foundry for organism engineering. Our first foundry, Bioworks1, launched in Spring 2015. We designed Bioworks1 to be capable of delivering many organisms to customers in many markets. Already, we're using Bioworks1 to concurrently develop 10+ organisms across multiple species and products.

    At the heart of Bioworks1 is high throughput genetic engineering across multiple species. Our approaches are designed to scale 100-1000X via software and automation. We are seeking genetic engineers to both scale our existing technologies in Biowork1 and define the next set of genetic technologies that will lie at the center of Bioworks2.

    The ideal candidate has led the development of a high-throughput biological process from scale-up through to successful operation, most likely for DNA synthesis or sequencing. A demonstrated ability to evolve a process in response to changing technology and demands is essential. Experience in a mixed team of software developers, process engineers, and biologists is important.

    RESPONSIBILITIES

    • On-board new species into the foundry
    • Develop new genetic methods and tools that are multi-species
    • Translate genetic methods and tools to be performed by software + automation
    • Work hand in hand with software and automation engineers to scale up genetic methods and tools 100-1000X
    • Develop processes for verification and quality control of constructed genetic parts and strains

    REQUIREMENTS

    • PhD or equivalent plus 5+ years of industrial experience
    • Prior experience in one or more of the following: high throughput pipelines, laboratory automation, software engineering, NGS, DNA synthesis and assembly, genome engineering

    To learn more about Ginkgo, check us out on Medium and BuzzFeed

    https://medium.com/the-os-fund/a-new-era-of-industrial-engineering-using-biology-dd4571aa6d27

    http://www.buzzfeed.com/stephaniemlee/this-startup-is-designing-yeast-to-make-brand-new-scents-fla#.ph2jnprJK

    We also feel it’s important to point out the obvious here – there’s a serious lack of diversity in our industry and it needs to change. Our goal is to help drive that change. We hope to continue to build a company whose culture promotes inclusion and embraces how rewarding it is to work with engineers from all walks of life. Making biology easier to engineer is a tough nut to crack - we can’t afford to leave any talent untapped.

     

    www.ginkgobioworks.com  


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    Ginkgo is building an industrialized foundry for organism engineering. Our first foundry, Bioworks1, launched in Spring 2015. We designed Bioworks1 to be a single foundry capable of delivering many organisms to customers in many markets. Already, we're using Bioworks1 to concurrently develop 10+ organisms across multiple species and products.

    At the heart of Bioworks1 is high throughput genetic engineering across multiple species. Our approaches are designed to scale 100-1000X via software and automation. We are seeking genetic engineers to improve and scale our existing technologies in Biowork1 and define and develop the next set of genetic technologies that will lie at the center of Bioworks2.

    The ideal candidate has led the development of a high-throughput biological process from development, validaton through to successful operation at scale, most likely for DNA synthesis or sequencing. A demonstrated ability to evolve a process in response to changing technology and demands is essential. Experience in a mixed team of software developers, process engineers, and biologists is important.

    RESPONSIBILITIES

    • Operate and improve processes for strain modification in Bioworks1
    • Apply DOE approaches to refine and improve genetic methods
    • Translate genetic methods and tools to be performed by software + automation
    • Work hand in hand with software and automation engineers to scale up genetic methods and tools 100-1000X
    • Develop processes for verification and quality control of constructed genetic parts and strains

    REQUIREMENTS

    • BS or MS in biology, microbiology, genetics or equivalent
    • Experience with molecular biology and/or genetic engineering of microbes
    • Familiarity with software or laboratory automation a plus

    To learn more about Ginkgo, check us out on Medium and BuzzFeed

    https://medium.com/the-os-fund/a-new-era-of-industrial-engineering-using-biology-dd4571aa6d27

    http://www.buzzfeed.com/stephaniemlee/this-startup-is-designing-yeast-to-make-brand-new-scents-fla#.ph2jnprJK

    We also feel it’s important to point out the obvious here – there’s a serious lack of diversity in our industry and it needs to change. Our goal is to help drive that change. We hope to continue to build a company whose culture promotes inclusion and embraces how rewarding it is to work with engineers from all walks of life. Making biology easier to engineer is a tough nut to crack - we can’t afford to leave any talent untapped. It is the policy of Ginkgo Bioworks to provide equal employment opportunities to all employees and employment applicants.

    www.ginkgobioworks.com


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    Are you a highly motivated biology scientist looking to join an exciting oncology focused R&D team? If so, this is a not to be missed opportunity to be a part of a professional and interactive team at a well-established leader within the oncology field.

    You will be responsible for keeping up with the latest novel therapies for oncology and advancing therapeutic programs from early targeting and biology to enable preclinical efforts. You will possess strong interpersonal skills as part of this role is expanding research relationships within the external community and acting as a liaison with key partners. If you hold a record of industry achievement and novel drug discovery knowledge, especially  in the Oncology, Cancer Biology, and Immuno-Oncology field, come join this amazing team and seize the opportunity to improve the lives of  many cancer patients.

    Requirements

    ·         Track record of industry achievement and strong drug discovery knowledge, especially in the oncology field and strong background target identification approaches and novel screening. 

    ·         PhD with at least 2+ years additional experience relevant to cancer drug discovery in industry or highly innovative academic settings. 

    Collaborative personalities with effective interpersonal and cross-functional communication are required. In addition a track record of novel oncology approaches in top scientific publications are a plus. 

    About StratAcuity
    Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

    CHEMISTRY IS EVERYTHING™


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  • 12/16/15--00:00: HR Associate
  • Toxikon Corporation, originally founded in 1977, is a Contract Research and Testing company with laboratories in Bedford, MA and Belgium.  Our mission is to provide quality pre-clinical research services to Pharmaceutical, Medical Device and Biotech industries. 

    Job Summary

    Toxikon is seeking an experienced individual with 3-5 years of Human Resources experience, preferably in the life science industry, for a full time challenging role in a fast growing medical device and pharmaceutical pre-clinical research organization.  The ideal candidate will focus on recruiting, performance management, onboarding, benefits, communication and corporate compliance.  Additionally, the individual will have demonstrated experience and knowledge with ADP Workforce Now.  

    Essential Duties

    • Manage recruitment and onboarding of all new hires within the ADP platform. 
    • Interface closely with Finance and HR Manager to support bi-weekly payroll processing, compensation, benefits administration and budgets (FTEs).
    • Ensure compliance and alignment of all job descriptions, job grades and compensation across the enterprise using the ADP platform. 
    • Provides analytics and reporting of all HR information within the platform, and provide updates to the ADP sites as required. 
    • Work in team building and communication by supporting Department Heads and all other managers. 
    • Provide continuous information and updates to the ADP platform for staff communication. 
    • Provide compliance and support of audits and work with Archivist to ensure appropriate archives and record retention for HR activities. 
    • Maintain conformance with Toxikon's quality mission statement and goals, and all labor compliance's and corporate accreditation's related to the HR function. 

    Minimum Qualifications

    • Bachelor's degree required, some IT background is preferred. 
    • 3-5 Years of Human Resources experience required. 
    • PHR certification is desired. 
    • Prior experience in a Finance role with demonstrated ability to audit and verify data accuracy, and ability to use WFN report writer may be considered. 
    • Self-motivated, confidential, organized, reliable, strong communicator, timely, and exceptional customer service skills for ensuring all management and staff needs are met.
    • Demonstrated experience in implementation of process improvements and TQM a plus. 

    To appy to this position go to: https://workforcenow.adp.com/jobs/apply/posting.html?client=toxcorp&jobId=13561&lang=en_US&source=CC2 

    For additional information about Toxikon go to www.toxikon.com. 

    Toxikon offers a comprehensive benefits program including: paid vacation, sick time, 401(k) plan with company match, medical, dental, vision care, life insurance, short and long-term disability insurances, flexible spending accounts, employee assistance program, employee referral bonus, discount programs and more.  

    Toxikon is an equal opportunity employer.  As a equal opportunity employer we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical leave entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state and local laws. 


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  • 12/16/15--01:22: Histology Research Associate
  • Toxikon Corporation, originally founded in 1977, is a Contract Research and Testing company with laboratories in Bedford, MA and Belgium.  Our mission is to provide quality pre-clinical research services to Pharmaceutical, Medical Device and Biotech industries. 

    Job Summary

    Toxikon is currently seeking a full-time Histology Research Associate.  Qualified candidates should be a team player, have a willingness to learn, be detail oriented, proficiency with computers and have well-developed time management skills.  

    Essential Duties

    • Trimming of tissues and organs harvested at necropsy. 
    • Embedding and processing of tissues. 
    • Microtomy
    • Routine H&E staining, other stains as required. 
    • Maintain and/or create GLP documentation as necessary, including relative SOPs and histology records, 
    • Maintain wet tissue archive. 

    Minimum Qualifications

    • Associate's Degree required, Bachelor's Degree in an area of the life sciences is preferred. 
    • IHC is preferred. 
    • Willing to learn new techniques. 
    • No previous experience is required.  However, experience with the following is preferred:
      • Worked with large animal species such as rabbit, pig, dog, sheet, etc. with tissue trimming. 
      • Microtomy
      • H&E staining and special staining. 

    Evenings and/or weekends may be required.  

    To apply to this position go to: https://workforcenow.adp.com/jobs/apply/posting.html?client=toxcorp&jobId=13563&lang=en_US&source=CC2 

    For additional information about Toxikon go to www.toxikon.com. 

    Toxikon offers a comprehensive benefits program including: paid vacation, sick time, 401(k) plan with company match, medical, dental, vision care, life insurance, short and long-term disability insurances, flexible spending accounts, employee assistance program, employee referral bonus, discount programs and more.  

    Toxikon is an equal opportunity employer.  As an equal opportunity employer we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical leave entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state and local laws. 


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  • 12/16/15--01:39: Sr. Business Analyst--Oracle
  • Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We are seeking a highly motivated, experienced Sr. Business Analyst who will support Oracle Cloud ERP, HCM and PBCS.  The Sr. Business Analyst will be actively supporting GL, Payables and Receivables, Project Costing, Purchasing, iProcurement, Contracts, Fixed Assets and Cash Management modules of Oracle ERP Cloud Services as well as Human Capital Management (HCM) and Planning and Budgeting Cloud Services (PBCS).  In this role, you will be responsible for business requirements analysis, writing functional design documents, communicating requirements to technical team members, system testing, implementation, and training.  This position will be pivotal in leading technical assessments and implementations of critical and highly visible new technology solutions, and supporting them in the Enterprise both short and long-term.

    About the Role:

    • Provide production support on day-to-day issues
    • Act as a liaison between business users and internal, external technical team members
    • Submit and manage Oracle Service Requests (SR)’s, manage the change process and document in accordance of System Development Life Cycles and Change Control
    • Support Oracle Transactional Business Intelligence (OTBI) reporting and analytics platform and provide standard, ad hoc reports from it
    • Identify process improvements and work with business partners effectively to implement system changes
    • Support and enhance Oracle Applications interfaces integrated with non-Oracle systems

    About You:

    • Bachelor’s degree or higher in Computer Science, Information Systems, or related field and 3-5 years of implementation and support experience as a Business Analyst on Oracle Applications R12 at minimum, Oracle Cloud Services preferred
    • 5+ years functional expertise in Oracle General Ledger, Payables, Receivables, Purchasing and Oracle Projects modules
    • Planning and Budgeting Cloud Services (Hyperion) a plus
    • Hands-on experience helping business users exploit Oracle Cloud or E-business full capabilities to meet the needs of the business.
    • Strong communication skills and ability to build positive, professional, and productive business relationships with internal and external clients.
    • To be successful in this role, must have experience in most if not all of the following: Strong SQL skills, strong OBI or OTBI, Financial Reporting Studio and or SmartView skills
    • Must have experience supporting any of the following Oracle Applications modules (Cloud a plus): General Ledger , Payables, Receivables, Purchasing, Project Costing and Billing
    • Nice to haves include: Experience with Oracle Workflow, Oracle Approvals Management Experience, Knowledge and experience with development tools (BI Publisher, Oracle SQL, Oracle Forms, Toad or SQL Developer.) Experience with higher level object oriented programming languages such as Java and PL/SQL
    • Experience working in a life sciences organization highly desirable
    • Demonstrated understanding of SOX and other regulatory related system requirements
    • Ability to execute and follow-through to completion and documentation
    • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
    • Independently motivated, detail oriented and good problem solving ability.
    • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
    • Excellent communication skills and ability to influence across multiple functions.
    • Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

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  • 12/16/15--01:55: Facilities Project Manager
  • Need a strong PM in our facilities and engineering department to lead mulitple large and small projects. Strong experience dealing with end users, architects, construction managers, engineers and furniture vendors.

     

    1. Based on assigned project, work with end users to develop project requirements.
    2. Attend and participate in all related meetings as necessary and be responsible for assuring meeting minutes are produced and distributed.
    3. Develop a project management plan, including project objectives and success criteria, deliverables, role/responsibilities/contact information. 
    4. Develop and maintain the overall project milestone schedule, and review and verify the integration of the Design Team’s services & deliverables, user responsibilities, permitting requirements, and anticipated construction schedules (including long-lead-time items).
    5. Communicate any value engineering opportunities.
    6. Establish, manage and oversee the Project Budget (including construction costs, soft costs, FF&E, and contingency) and provide a bi-weekly report to the owner.
    7. Assist the Owner in qualifying, selecting, retaining, and coordinating additional professional services, including Design Team, Construction Manager, Furniture Vendor and other professionals necessary to complete the project. Prepare and issue RFPs, conduct bid tabulations, evaluate proposals, and make recommendations to the Owner. 
    8. Support the negotiation of appropriate contracts for all professional services.
    9. Assure all required permits are obtained for the project.
    10. During construction, advise the Owner regarding the status of budget, schedule and quality by issuance of a Monthly Project Report. The Project Manager will advise the Owner, in a timely manner, of situations which have increased, or may increase, the cost of the Project; may cause a delay in the completion of the Project; has or may result in the installation of work or material which is not acceptable and in accordance with plans and specifications developed for the Project.
    11. Schedule and conduct on-site weekly progress meetings involving the Owner, Designer, and Construction Manager to review, resolve and plan in areas such as budget, schedule and quality. Meeting Minutes will be recorded and distributed, including an Outstanding Action Item Log, detailing the status of key decisions, responsibility and required timing.
    12. Review requests for changes, submit written recommendations to the Owner and negotiate Change Orders, with final terms and price subject to approval by Owner.
    13. Review applications by Consultants and Trade Contractors for progress and final payments.
    14. Review the CM’s Master Project Schedule and advice the Owner on issues potentially impacting timely completion.
    15. Maintain at the Project site for the Owner, one PDF electronic record copy of Contracts, Drawings, Specifications, Addenda, Change Orders and other modifications, in good order, and in addition, approved Shop Drawings, Product Data, Samples and similar required submittals. The Project Manager will make such records available to the Owner during the performance of the work and upon completion of the Project will deliver them to the Owner in electronic form.
    16. With the Owner’s maintenance personnel, design consultant, and commissioning agent, the PM will observe the Trade Contractor’s final testing and start-up of utilities, operational systems and equipment, if applicable.
    17. Coordinate all inspections to determine whether the Work is substantially complete, including review and feedback regarding the Construction Manager’s punch list.
    18. Receive and review as-built drawings with owner for accuracy and ensure compliance with owner’s internal CAD standards.
    19. Receive and review for completeness all manuals, warranty information and attic stock for delivery to the Owner. 
    20. Schedule and facilitate a Lessons Learned meeting at the conclusion of the project, including recording and documenting the meeting activities and submitting a report to the Owner.
    21. Work with Operations Team to review project deliverable s and schedule work to be completed by each group (IT, Security, Facilities Ops, EHS, Asset Team, A/V).


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    Have you been searching for a job where you will be part of a motivated, fun team that has to think on their feet? If so, keep reading! Our client, a pioneer in developing drugs to cure genetic diseases, is looking for a talented and motivated person to join their team. 

    You will have the opportunity to be a part of a team that creates new drugs, using cell-based and biochemical assay development, and drug/target mechanism of action, and will be able to challenge yourself while troubleshooting and solving problems. 

    The ideal candidate will have at least 4 years of experience with a life science, and will be recognized as an expert in fields such as molecular and cellular biology, mammalian cell culture & small molecule evaluation in cell-based and biochemical assays. They must be considerably self-sufficient while performing tasks of moderate difficulty. 

    Experience is key!

    About StratAcuity

    Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. 

    CHEMISTRY IS EVERYTHING™

     


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  • 12/16/15--23:24: Lead Clinical Data Manager
  • Primary Roles:
    The Clinical Data Manager will have a demonstrated ability to oversee the data management activities across a single clinical program or group of related studies. Provides Data Management leadership and expertise to project and study teams. Will have an good knowledge of the end to end clinical research and data management processes, as well as global regulatory and industry rules and guidance (i.e. ICH, GCP) to support drug development processes and global project submissions through to approval. Responsible for managing data management components of project and study budgets and vendor performance. May mentors team members and more junior staff and may direct activities of contract Data Manager staff

    Responsibilities:
    30% Delivering Excellence: Takes leadership role in project implementation
    * As a member of the clinical study or project team, ensures oversight of the Data Management CRO ; provides status reports/updates, resolves disputes, and ensures timely acquisition of high quality deliverables from the CRO
    * Provides Data Management expertise to the team in identifying opportunities for process and budgetary optimization
    * Coordinates with Biostatistics and Statistical Programming to ensure appropriate design, documentation, testing and implementation of SAS data deliverables according to internal and regulatory standards
    * Works with team members via matrix relationships (internally or at
    CROs) by directing work, resolving problems and/or providing guidance

    25% Accountability and Ownership: Drives accountability at every possible level
    * Ensures Data Management CROs are delivering quality data and documentation on time, on budget and to Shire's quality standards and SOPs
    * Reviews Data Management CRO performance measures and evaluates cost/benefit of actions taken to remedy or improve performance
    * Collaborates with CRO and study team members to identify and resolve issues impacting goal attainment.

    15% Judgment and Decision Making: Evaluates immediate business impact and takes decisive action
    * Provides within and between study comparisons of DM timelines for assigned projects. Takes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve
    * Contributes to regular budget forecasting and regular cost accrual processes and proactively communicates to the team budgetary impacts of decisions or processes implemented to achieve results

    10% Courage to challenge: Takes risks and challenges norms to support tomorrow's needs
    * Supports consistent implementation of globally agreed study delivery and clinical development strategies including process and technology related to DM Operations

    10% Serving Customers: Partnering with customers as a trusted consultant and becoming an integral part of customer's decision making
    * Supports each clinical study and project team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines. Consults with the team(s) to ensure the teams' long-term needs are addressed.
    * As Data Management lead to the clinical study, becomes involved in decision making processes to ensure maximum performance of the team. Provides Data Management expertise to the teams in customer oriented point of view
    * Leads development of Data Review Plans; contributes to other key study level documents (e.g. protocols, SAPs)

    10% Building Authentic Relationships: Building trusting relationships that will enhance current and future needs
    * Leads in developing trust through transparency in communication and individual actions; ensures outcomes are team driven rather than individually driven; promotes collaborative team and organizational success

    Education and Experience Requirements:
    * B.S. degree in Scientific or related field is preferred.
    * Minimum of 5-7 years as a Sr. Data Manager within a Data Management organization
    * Experience with leading teams and/or organizations.
    * CCDM certification preferred Key Skills and Competencies:
    * Must be able to produce data management reports
    * Strong attention to detail and accuracy is a must.
    * Ability to read, analyze and interpret complex technical documents.
    * Ability to present complex issues in oral and written form.
    * Strong knowledge of MS Word, Excel, PowerPoint, Access and Outlook.
    * Must be able to independently present complex information to departmental management, professional organizations, CROs and the medical community.

    Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=c3N6Y3plc255LjE0NTg3LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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    Primary Role:
    The Regional Disease Education Manager (RDEM) is responsible for the implementation of the strategic initiatives developed by the leadership team. The RDEM will educate and raise awareness of specific Lysosomal Storage Disorders, Gaucher Disease and Hunters (MPS II) Syndrome, with health care providers in a defined geography to uncover patients that are appropriate for Shire's therapies. The RDEM will be expected to meet or exceed set expectations related to patient identification and the development of a robust sales funnel. Further, once an appropriate patient/provider is identified the RDEM will partner with the Regional Business Manager (RBM) to assist with the steps necessary to get the patient on drug.

    Responsibilities:
    This position will be responsible for all disease education related activities within their geographic responsibility, including achievement of MBO's, business planning in partnership with the RBM, and expense control. The RDEM will educate and inform HCPs on Gaucher Disease and Hunters (MPS II) Syndrome. They will describe signs and symptoms of the diseases and inform on the differential diagnosis process. They will educate HCPs on the appropriate treatment referral route. They will attend conferences and workshops as an exhibitor or presenter.

    Education & Experience Requirements:
    * Minimum of a Bachelor's degree in business or science related field is required
    * Healthcare provider, Nursing, Genetic Counselor background preferred
    Minimum of 4 years of sales experience required
    * Minimum of 2 in specialty biologics preferred
    Complex sales model experience is preferred
    * A consistent track record of success (Top 20% performance), President's Club or other top tier awards preferred
    * Experience providing complex disease education preferred
    * Rare disease experience is a plus
    * Demonstrated pioneering experiences required

    Other Job Requirements:
    * Candidate must live in territory
    * Must work evenings and weekends as needed
    * Extensive travel required and varies by territory
    * Candidates must possess a powerful sense of urgency, a strong desire for results and a strong work ethic.
    * Territory includes DC, Maryland and Virginia

    About Shire:
    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=bHZhaWwuMjk2OTYuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20


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    Primary Duties:
    The Global Medical Affairs Strategic Planning Lead - Learning and Launch Ops (LLO) in designated Therapeutic Areas and Regions will:
    * Work collaboratively with cross functional teams to drive the translation of Medical/ Product strategy into clear and actionable pre-launch and launch plans to maximize GMA Product Launch activities.
    * Lead the GMA Strategic Launch Operations Team, ensuring all GMA functions complete launch initiatives and programs within approved timelines
    * Collaborate cross functionally and engage with the Compliance, Commercial, Regulatory, Legal, HEOR, Clinical and GMA Teams to determine and share launch strategy and tactics.
    * Analyze and determine successful launch measures and report progress to plan
    * Oversee and manage mandatory GMA Compliance training including creation and modification of GMA Job roles and assignment of SOPs
    * Serve as GMA training manager on R&D Compliance and Training Network Team
    * Support delivery of priority training elements to hiring managers for the new hire on-boarding process

    * Work with the Global Medical Team Lead (GMTL), to develop and execute global medical product launch strategy for the specified Product/Disease Area, appropriately aligned with overall strategy and incorporating R&D functional strategies (clinical, regulatory, HEOR, PV, compliance)
    * Develop, maintain and track robust, cross-functionally aligned and integrated product launch plan encompassing all key operational deliverables associated with the Medical Plan Launch strategy
    * Drive the launch activities, ensuring all GMA Teams (Medical Strategy, Medical Communications, Medical Information, Scientific Publications, Sys-Ops and GMA Training) are on target for on-time completion of all launch and early Life Cycle Management (LCM) deliverables.

    Responsibilities::
    50%:
    Drive global medical launch strategy:
    * Work with the GMTL and GMT to develop medical launch strategy, including in-line R&D LCM strategy, publications strategy, congress strategy, customer interaction strategy, and the scientific communication platform for the disease area / brand(s), aligned with product strategy.
    * Participate and/ or lead functional (e.g. publications, medical communications, medical training) and in-line R&D teams in developing plans supporting global medical launch strategy
    * Collaborate with commercial to ensure aligned and medically appropriate commercial launch strategy, planning and execution.
    * Participate in development of product strategy; provide medical affairs and R&D inputs for product(s) to Product Strategy Team
    * Promote visibility and transparency of information within the GMT, across launch-aligned Project Teams and other forums to accelerate decision making, obtain alignment, and increase foundational knowledge, identify and communicate product related objectives, issues, risks, and where applicable, facilitate cross-functional discussion.

    50%:
    Lead and operationalize GMA Learning Operations
    * Oversee and facilitate the new hire training program and delivery of relevant GMA trainings (including TA, compliance and systems):
    - Organize new hire live training forums
    - Manage and develop virtual GMA new hire training tools and establish processes as needed
    * Interface with GMA Training Director on TA training coordination and vendor management
    * Work with R&D compliance and analytics to oversee and address GMA training compliance reports
    * Work with HR and Leadership & Development to support professional development programs and capabilities development tools
    * Support Audit responses across LOCs and on point for CIA related audit activities (e.g. IRO audits)

    Education and Experience Requirements:
    * A medical or science Bachelor's degree is required
    * A higher level degree (e.g. MBA, MD, RN, Masters, PhD or PharmD) is preferred
    * Greater than 7 years of experience in the biopharmaceutical industry, preferably leadership within a matrix structure is required

    Other Job Requirements:
    * 30% Domestic and International travel may be required for this position.

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=amRpZXR6LjE1NzQ1LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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    Primary Role
    * Under the direction of the line manager, the CMC Regulatory Submissions Manager supports
    the management and oversight of the CMC Regulatory Submissions for Shire's Global Portafolio of early development programs (IMPD/CTA/IND).
    * The Regulatory Submissions Manager is also responsible for execution of the global CMC submission process (Creation, Review, Approval, Submission and * Commercial Implementation of CMC Dossiers for Marketing Applications and Post- Approval) by working closely with Product Development, Regulatory, QA, * GPT and MS&T crossfunctional project teams to support the execution of operational activity, monitor adherence to the process, periodically evaluate the metrics, revise the process as required, implement changes and provide appropriate training and tools.
    * The manager will be responsible for tracking global submission activities for Biologics and Chemically Synthesized Products.
    * In addition, the Regulatory Submissions Manager will support the global CMC Regulatory Submissions and Document Compliance department with expertise in general pharmaceutical development of global products, submission ready standards and eCTD requirements.

    Responsibilities
    80% Regulatory Submissions
    * Knowledge of global CMC regulatory submission requirements
    including submission formats (eCTD for IND, IMPD, NDA, MAAs and NEES).
    * Department lead on the clinical and commercial CMC submission
    processes.
    * Tracking global submission activities. Oversees regulatory
    submissions trackers
    * Supports the monitoring of global CMC process, evaluation of metrics periodically, monitoring the process, supports changes and provides training and tools. Maintains operational excellence of the process.
    * Oversees management of the content planning of regulatory
    submissions within PD.
    * Provides guidance for submission eCTD granularity.
    * Maintains oversight and executes documents to submission ready
    standard for CMC regulatory submissions.
    * Maintains global module 3 templates.
    * Oversees management of Quality 3D domain: Quality Folder, PD file guide, Annex 3, Submission ready standards guide.
    * Maintains awareness of current trends in regulatory requirements
    through literature searches and networking.
    * Basic knowledge of US, Canadian, European regulatory requirementsfor APls and drug products for biologics and chemically synthesized.

    20% Knowledge Strategy:
    * Actively contributes to system improvements by demonstrating innovation and Shire's brave values
    * Involved in department initiatives to create efficient, transparent and compliant practices

    General
    * Is an active member of Product Development (PD) group .
    * Familiar with EQMS.

    Education & Experience Requirements
    * Bachelor's degree (or higher) in Chemistry, Pharmacy, Pharmaceutics, Chemical
    * Engineering, or closely related field is desirable.
    * Minimum 5 years experience in the Pharmaceutical Industry is required.
    * Familiarity with pharmaceutical product development, regulatory guidelines and experience in regulatory submissions (in particular CMC Module 3 information and QOS documents) throught out the development lIfecycle is highly desirable.
    * Experience in working with the outsourcing model is preferred.

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=amVucy44Mzc0Ni4zMTY3QHNoaXJlLmFwbGl0cmFrLmNvbQ


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  • 12/17/15--00:04: Principal Process Engineer
  • Primary Role
    As a key member of the Manufacturing Science & Technology group, this individual will be responsible for providing technical and scientific leadership supporting process validation and technology transfers for external manufacturing related to Drug Substance and Drug Product (Biologics Products). This individual will lead or contribute as a key member of various cross-functional project teams and will interact extensively with other departments within Shire as well as external partners/CMOs.

    The responsibilities will include:
    * Participate in the development, implementation and maintenance of Shire policies, guidelines and procedures that pertain to all aspects of process validation lifecycle and technology transfer
    * Support/lead process validation related activities for the design, qualification and continued process verification of Shire's manufacturing processes, including identification of opportunities for improvement and consideration of long-range strategic goals and objectives
    * Support/lead technology transfer related activities for external manufacturing to partners and/or CMOs, including input on equipment design, process scale-up and associated transfer risks, and transfer of knowledge management
    * Lead/perform facility fit exercises for technology transfer and process changes, and develop mitigation strategies to ensure operational and validation success
    * Interface with other departments (e.g., Engineering, Facilities, Manufacturing, Regulatory Affairs, Validation, Quality Control and Quality Assurance) and external organizations (e.g., CMO) to achieve Shire/MS&T objectives relating to process validation, technology transfer and other related activities
    * Contribute to the development of process validation and technology transfer strategies, and manage related studies supporting validation and transfer activities related to Drug Substance and Drug Product (Biologics Products)
    * Contribute to the development of process validation master plans including those for process characterization (process design), as well as process qualification and verification, and support the execution of the plans
    * Review process validation protocols, data and reports.
    * Review proposed changes to validated processes and identify requirements necessary to maintain validated status
    * Contribute to the maintenance of departmental expertise in process validation and technology transfer
    * Approximately 10-20% travel, as needed

    Responsibilities
    * 30% Miscellaneous technical writing and/or review of protocols, reports, regulatory submissions, agency responses, product quality reviews, deviations, investigations, CAPA, change controls, etc.
    * 30% Interface and collaborate with customers (including external collaborations) to achieve project goals
    * 15% Contribute to the development, implementation and maintenance of process validation and technology transfer policies, guidelines and procedures
    * 20% Develop process validation strategies and master plans, and manage/support their execution during process validation and technology transfers
    * 5% General and administration

    Education & Experience Requirements
    * Requires bachelor's degree in a technical discipline with a minimum of 10 years relevant experience in the biopharmaceutical industry
    * Experience in process development, technology transfer and process validation
    * Understanding of multiple biopharmaceutical processing techniques and expression systems, including mammalian cell culture, microbial fermentation and plasma production and associated purification methods and technology
    * Expertise in purification and/or cell culture
    * Knowledge/experience in Drug product manufacturing and Process Validation for Biologics Products
    * Understanding of clinical and commercial manufacturing operations
    * Experience leading complex and challenging projects
    * Experience contributing to and/or leading process risk assessments
    * Knowledge of current industry quality and validation expectations and guidelines

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=amVucy45NjM3Ni4zMTY3QHNoaXJlLmFwbGl0cmFrLmNvbQ


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  • 12/17/15--00:06: GMA Strategic Planning Lead
  • Primary Role:
    In the designated Regions (IMA) or Therapeutic Area(s)
    * Support definition and implementation of projects supporting GMA strategy
    * Supporting GMA strategic and operational planning and budgeting processes at the local level, in alignment with corporate, business unit and regional planning and budgeting processes
    * Support the leader(s) of the Global Therapeutic Area(s) and Global Medical Teams (GMTs) in the development of Global Medical Plans and Medical Launch Plans, and supporting the design and implementation of projects with strategic impact
    * Track and communicate established, appropriate performance metrics across GMA, with a focus on Global metrics
    * Implement of project management solutions for Global teams, including in new expansion markets
    * Support the operational effectiveness and organizational excellence of select Global Medical Teams (GMTs)
    * Manage vendor partners in execution of projects supporting GMA strategy
    * Continuously work with GMA Strategic Planning colleagues and Global team members to improve existing processes across GMA
    * Manage and execute the GMA communication plan, focusing on communication to Therapeutic Area and or Region team members

    Responsibilities:
    90%: Support of GMA Strategy Implementation
    * Support definition and implementation of projects supporting GMA strategy
    * Facilitating GMA strategic and operational planning and budgeting processes at the Global levels, in alignment with corporate, business unit and regional planning and budgeting processes
    * Support the leader(s) of the Global Therapeutic Area(s) and Global Medical Teams (GMTs) in defining Global Medical Plans and Medical Launch Plans, and in support of implementing projects with strategic impact
    * Track and communicate established, appropriate performance metrics across GMA, with a focus on Global metrics
    * Implement of project management solutions for Global teams, including in new markets
    * Support the operational effectiveness and organizational excellence of select Global Medical Teams (GMTs)
    * Manage vendor partners in execution of projects supporting GMA strategy
    * Continuously work with GMA Strategic Planning colleagues and Global team members to improve existing processes across GMA

    10%: Internal Communication and Coordination
    * Act as the representative of GMA Strategic Planning
    * Manage and execute the GMA communication plan, focusing on communication to Therapeutic Area and Region team members

    Education & Experience Requirements:
    * A Bachelors Degree in a related field (e.g. in Business Administration, Finance or a Science or Engineering discipline). An advanced degree (e.g. MBA or PharmD) is highly desirable.
    * 5+ years of related work experience
    * Biopharmaceutical industry is preferred
    * Demonstrated experience in strategic planning, operations, management consulting or related activities is required
    * Experience in Medical Affairs is preferred

    Other Job Requirements:
    * Availability to travel approximately 20% of time
    * Time zone flexibility is a must (e.g. availability to participate in early or late meetings/teleconferences, weekends, etc.)

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=amRpZXR6Ljg2NTgwLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


    0 0

    Join bluebird bio’s passionate and collaborative team by contributing to the overall success of our novel gene therapy approach.   bluebird bio seeks an outstanding Business Systems Analyst/Sr. Business Systems Analyst for Clinical Development (Clinical Operations, Quality, Regulatory Affairs).  Reporting to Clinical Regulatory (Clin-Reg) IT Management, the primary function of this role will be to provide support in managing both ongoing and future projects within the Clinical Development Portfolio.   This will initially include but not be limited to: EDMS, LMS, QMS (CAPA/Audit), and Literature Management.   We are interested in self-motivated candidates requiring little supervision, that embrace learning within challenging circumstances, and who will thrive in a fast-paced, dynamic environment.

     

    About the Role:

     

    • Ability to effectively partner with Business Process Owners, in driving project selection and implementation through effective gathering and analysis of user requirements.
    • Manage product selection process through appropriate levels of due diligence (RFI or RFP).
    • Oversee contracting and negotiations, and manage product vendor.
    • Manage a project team through the project lifecycle, providing guidance and support as necessary through all phases.  Track and manage project using PMO tools ensuring that projects are delivered in a timely fashion within budget.
    • Knowledge/experience   content management and training management, quality management, eTMF, submission management, data collection/processing of EDC, and safety data. 
    • Work in concert with the user community to actively manage and optimize solutions through their lifecycle

    About You:

    • BS/BA; MBA preferred
    • 7-8+ years overall experience in drug development with at least 3 years program management experience in the biopharmaceutical industry
    • Working experience supporting Enterprise Document Management, Regulatory Information Management and Quality Systems in a validated environment a must.
    • Outstanding communication, analytical, and organizational skills.
    • Proven ability to balance the strategic needs of the program with tactical day-to-day activities.
    • Strong interpersonal skills with the ability to motivate others, influence without authority, and negotiate conflict situations.
    • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders and colleagues.
    • A passion for addressing the critical unmet medical needs of patients.
    • Willingness to embrace and demonstrate the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself.

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  • 12/17/15--07:21: Director, Corporate Tax
  • Department: Other Job Opportunities

    Job Title: Director, Corporate Tax

    Job Location: Waltham, MA

    Description:

    TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of patients with cancer. Our team of passionate associates develops and will commercialize safer and more effective supportive care agents and therapeutics. We take our responsibility to patients seriously. Reporting to the VP Finance and Administration, this position will be responsible for the following:

    Seeking individual who wishes to be responsible for managing both tax compliance and tax strategic planning related to all domestic (Federal and State) and international aspects for a newly commercial, expanding, public biotechnology Company. Position is responsible for ensuring proper tax provision preparation and all financial reporting requirements related to income and other taxes.

    Key Responsibilities:

    • Set timelines, prepare requested documents, support permanent and temporary differences, provide relevant updates, and review final tax returns/filings.
    • Working closely with the accounting and financial reporting team, manage the quarterly tax close and reporting process, including the tax provision, effective tax rate analysis and deferred taxes. Review, analyze and maintain support for valuation allowances and stock compensation impacts. Prepare tax footnotes and disclosures for SEC filings; coordinate with the accounting team, external advisors and external auditors.

     

    Work with CFO and finance department to:

    • Oversee tax strategy projects, including potential establishment of sales corporation, certification of the R&D tax credit and various NOL support initiatives, including monitoring Sec. 382 limitations.
    • Working with the CFO and financial planning and analysis team, assess and implement domestic and international corporate tax strategic planning. Assist with determining the impact of significant transactions, events and potential changes in business operations.
    • Develop, improve and maintain all tax-related compliance and business processes involving VAT, sales and use tax, personal property tax, franchise tax, foreign withholding and other taxes.
    • Ensure that tax policies and procedures adhere to Sarbanes-Oxley compliance effort including assisting with process design changes and documentation of relevant portions of control cycles.
    • Conduct tax research and provide timely assistance/leadership of various additional projects as they arise.

     

    Abilities Needed for Success:

    • Proven ability to work with a high level of integrity, accuracy, and attention to detail
    • Strong technical/analytical skills to identify and solve problems.
    • Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.
    • Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget.
    • Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
    • Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.
    • Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strengthen decision-making.
    • Proactively seeks out and recommends process improvements.
    • Entrepreneurial, enjoys working in a fast-paced, small-company environment.
    • Flexibility in handling work flow in a multi-tasking environment.
    • Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of confidentiality.

     Job Requirements:

    • CPA with minimum of 8-10 years of relevant work experience and “Big Four” or large regional accounting firm experience.
    • Experience working with biotechnology/pharma/life science companies preferred. Experience with international subsidiaries preferred.
    • Individual must be detail oriented, able to work independently at a high level of complexity and have strong communication and analytical skills.
    • Individual must be able to work in a fast-paced dynamic team environment.

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    We seek an experienced Associate Director/Director, Regulatory Affairs who will be responsible for developing regulatory strategies for our innovative gene therapy oncology programs.  This position will be responsible for the preparation, submission and approval of INDs and CTAs, pediatric investigation plans, orphan drug designations, and managing corresponding interactions with regulatory authorities.Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.

    About the role:

    • Proactively participate in design of regulatory strategies for the development of gene therapy products for oncology in the US and the EU. 
    • Manage preparation and submission of high-quality regulatory dossiers in the US and the EU according to set timelines; this will require cross-functional interactions, excellent project management and writing skills, as well as a good understanding of the underlying science.
    • Manage transparent and proactive regulatory agencies interactions for oncology projects
    • Collaborate with regulatory-CMC function to ensure seamless integration of CMC components to all submissions
    • Drive adherence to regulatory guidelines for development of gene therapy products.
    • Participate in regulatory intelligence activities; monitor regulatory guidelines and trends.

    About you:

    • BA/BS degree in life sciences, MS/PhD preferred
    • At least 5-10 years of pharmaceutical product development, preferably oncology biologics
    • Well-versed in regulatory strategy, and regulatory science writing
    • Experience as primary regulatory author for IND and CTA documents
    • Knowledgeable in ICH, FDA and EMA guidelines
    • Understanding of advanced therapy products development
    • Ability to work independently and thrive in a fast-paced environment.
    • Excellent people leadership skills
    • Excellent communication skills and ability to influence across multiple functions
    • Experience in the development of biomarker in oncology and immuno-oncology, and translation of these biomarkers into use in clinical trials, including development of laboratory developed tests (LDTs) and in vitro diagnostics (IVDs)
    • Experience in the field of gene or cell therapy and orphan diseases
    • BLA/MAA experience

     

     

    • Ability to execute and follow-through to completion and documentation.
    • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
    • Independently motivated, detail oriented and good problem solving ability.
    • Excellent communication skills and ability to influence across multiple functions.
    • Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

     


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