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Career postings for the Massachusetts Biotechnology Council

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  • 12/28/15--09:00: Clinical Supply Manager
  • Merrimack is a fully integrated biopharmaceutical company that views cancer as a complex engineering challenge. Through systems biology, which brings together the fields of biology, computing and engineering, Merrimack aims to decrease uncertainty in drug development and clinical validation, and move discovery efforts beyond trial and error. Such an approach has the potential to make individualized treatment of patients a reality. With five candidates in clinical trials, several in preclinical development and multiple biomarkers designed to support patient selection, Merrimack is building one of the most robust oncology pipelines in the industry. Merrimack has a New Drug Application under review for its lead product candidate, MM-398, for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. For more information, please visit Merrimack's website at www.merrimack.com or connect on Twitter at @MerrimackPharma.

    We are looking for a talented Clinical Supply Manager to join our team in Cambridge!

    Job Responsibilities: 

    • Work closely with Clinical Operations to monitor and track clinical trial enrollment plans and actual enrollment

    • Collaborate with Clinical Trial Managers, clinical packaging sites, applicable internal Merrimack functional areas, CROs, and others as applicable to evaluate and maintain up-to-date status records and reporting for all clinical supply-related activities across projects / products

    • Develop, manage, and utilize appropriate inventory reporting tool(s), including Oracle, for maintaining clinical supply inventory and forecast records

    • Manage communication and review process for recommended clinical packaging plans

    • Communicate clinical packaging plans to applicable contract packaging sites, and ensure effective management of clinical packaging site activities

    • Develop and maintain information and reporting, in collaboration with Regulatory Affairs and Quality Assurance, to ensure alignment of regulatory filing status and Quality disposition status with availability of appropriate clinical trial inventory

    • Develop and maintain information and reporting, in collaboration with Quality Control, to ensure transparency of project / product current expiry periods, and plans for expiry extension

    • Collaborate with Supply Chain Planning to develop and manage routine Supply & Ops Planning meeting for clinical projects / products

    • Collaborate with Supply Chain External Supply to develop and maintain reporting of end-to-end supply chain status for clinical trial inventory, inclusive of logistical activities

    • Assist is coordinating and monitoring change control activities relative to clinical trial products

    • Develop and maintain a master clinical trial inventory tracking report

    • Collaborate with Clinical Operations, packaging CROs, Merrimack QA and regulatory agencies to develop regulatory compliant labels for finished product

    • Assess, manage, and track the purchase, distribution and labeling of comparator products and other miscellaneous ancillary clinical trial material

    • Collaborate with Clinical Trail Managers to develop the drug distribution strategy for each trial and lead the development, review and acceptance testing of IVRS when applicable

    • Monitor and report on clinical supply inventory for each project / product

    • Manage and track inventory at site level and place manual orders as needed

    • Develop and maintain applicable metrics to monitor performance relative to clinical trial inventory and planning

    • Other duties and activities as defined by management to enhance management of clinical trial inventory

    • Collaborate with Clinical Trial Managers and Project Leads to both gather project / product clinical trial forecast requirements and demand history data, and generate / revise clinical trial inventory forecast requirements for planning purposes

    • Collaborate with Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, number of countries, etc.

    • Collaborate with Supply Chain Planning to ensure that clinical supply inventory and forecast information is included in the integrated planning process 

    Requirements: 

    • Bachelor’s degree in an applicable discipline

    • 7 - 10 years clinical supply management or equivalent experience in the pharmaceutical / biopharmaceutical industry

    • Strong background in working within ERP systems, preferably Oracle

    • Ability to communicate effectively both orally and in writing both within Merrimack, and with external vendors and partners

    • Ability to work both independently, and in a team environment

    • Ability to work in a fast paced and dynamic environment

    • Strong working knowledge of standard business software, including MS Excel, Word, and PowerPoint

    • Strong analytical and organizational skills

    • Minor travel may be required, up to 10%

     To apply please go to: https://app.jobvite.com/j?cj=osrO1fws&s=Mass_Biotech_Council


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  • 12/28/15--09:00: Clinical Research Scientist
  • Merrimack is a fully integrated biopharmaceutical company that views cancer as a complex engineering challenge. Through systems biology, which brings together the fields of biology, computing and engineering, Merrimack aims to decrease uncertainty in drug development and clinical validation, and move discovery efforts beyond trial and error. Such an approach has the potential to make the more individualized treatment of patients a reality. To that end, Merrimack has five candidates in clinical trials and several in preclinical development, and has identified multiple biomarkers that may inform a more efficient treatment selection. Merrimack has a New Drug Application under review for its lead product candidate, MM-398, for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.

    The ideal candidate will Contribute to the strategic design of clinical trials and provide clinical oversight of the study execution in collaboration with all members of the clinical study team. He or she will understand the current clinical landscape and future implications for relevant indications/patient populations, based on previous pivotal trials and ongoing trials and identify potential Investigators and clinical sites; and contribute to site selection and/or site activation.

    Job Responsibilities:

    • Contribute to the strategic design of clinical trials
    • Author and/or review Clinical Protocols and Amendments, Investigator Brochures, regulatory documents, annual reports, strategic documents, risk management plans, publications and abstracts/presentations for internal and external audiences
    • Conduct literature searches to keep updated with medical and other scientific developments relevant to the product and competitor products
    • Identify Key Opinion Leaders in the field, and participate in advisory board meetings
    • Understand the current clinical landscape and future implications for relevant indications/patient populations, based on previous pivotal trials and ongoing trials
    • Provide clinical oversight of the study execution in collaboration with all members of the clinical study team
    • Identify potential Investigators and clinical sites; and contribute to site selection and/or site activation
    • Provide scientific expertise to study managers on both scientific and operational issues related to the study, and serve as a resource to clinical operations/CTMs to address any questions or clarify issues arising during the conduct of the study
    • Review draft CRFs and provide input into CRF design process
    • Participate in the compilation and analysis of study data to draw conclusions for both internal  and external presentation
    • Participate in the tracking and analysis of safety data, identify any potential safety signals within a given trial and across trials
    • Interface with  physicians, hospitals, patient advocacy groups, and any other necessary group to support the development of the project
    • Provide a functional link connecting translational research to the clinic

    Requirements:

    • An advanced degree (in life sciences) with 5+ years of relevant clinical research and/or clinical development experience within biotech/pharma preferred.  A Bachelor’s degree with 10+ years of relevant clinical research and/or clinical development experience within biotech/pharma will also be considered
    • Oncology experience preferred; ex-US experience a plus
    • Experience contributing to the strategic design of clinical trials
    • Experience authoring and/or reviewing clinical documents
    • Understanding of the current clinical landscape and future implications for relevant indications/patient populations
    • Experience providing both scientific and operational expertise to clinical studies
    • Ability to interface with physicians, hospitals, patient advocacy groups, etc.
    • Strong written and verbal communication skills
    • Passion for fighting Cancer

     


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  • 12/28/15--06:17: Manager Clinical Supply
  • Our biotechnology client is a world leader in improving lives. Their highly collaborative and growing Clinical team is on the hunt for an experienced manager of Clinical Supply. This position will be working with both Clinical Operations and Medical Affairs to plan and manage supplies for investigator initiated studies.  In addition you will be working closely with external vendors to ensure critical information is communicated with respect to manufacturing, packaging and labeling of clinical drug supplies in a timely manner.

    REQUIREMENTS:

    • Minimum of Bachelor’s degree in Chemistry, Pharmacy or related technical field with 3-5 years in Pharma industry on investigational product supplies for studies in both US and Global markets.
    • Understanding of GCP’s, GMP’s and ICH guidelines.
    • Basic understanding of IRT and ERP systems

    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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    T2 Biosystems, founded in 2006 by renowned scientists from MIT and Mass General Hospital, is an in vitro diagnostic company that has developed an innovative and proprietary technology platform that offers a rapid, sensitive and simple alternative to existing diagnostic methodologies.     We are using our T2 Magnetic Resonance platform, or T2MR, to develop a broad set of applications aimed at reducing mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier.  T2MR enables rapid detection of pathogens; biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, and can detect cellular targets as limits of detection as low as one colony-forming unit per milliliter, or CFU/ml.  Our initial development efforts utilizing T2MR target sepsis and hemostasis, which are areas of significant unmet medical need in which existing therapies could be more effective with improved diagnostics. We have completed a pivotal clinical trial for our T2Dx diagnostic instrument, or T2Dx, and T2 Candida panel, or T2Candida, which have the ability to rapidly identify the five clinically relevant species of Candida, a fungal pathogen known to cause sepsis.

    On September 22, 2014, T2 Biosystems received market authorization from the U.S. Food and Drug Administration (FDA) for its first two products, the T2Candida® Panel and the T2Dx® Instrument for the direct detection of Candida species in human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. T2Candida and T2Dx, for the first time, provide sensitive detection of specific sepsis-causing pathogens directly from a whole blood specimen in approximately four hours. All other currently FDA-cleared detection systems require cultured blood samples for species-specific identification and take two to five days or more to provide results.

    T2 Biosystems was named to the FierceMedicalDevices "Fierce 15" list in 2012, received the prestigious SBANE award in 2013 and received the Most Promising Company award at the Personalized Medicine World Conference in 2014.

    We are seeking a talented and highly motivated individual to join our Research and Development Team working on a novel diagnostics platform, as Manager/ Sr. Manager, Assay Development

    Responsibilities:

    • Manage a molecular diagnostics assay development project and team in a hands-on manner through all stages of development under design control, FDA submission and during pre-launch activities
    • Achieve assay, reagent, and controls performance metrics while maintaining QSR compliance of project documentation and processes
    • Effectively plan, resource and achieve milestones and timelines
    • Provide direction in the assay development process to ensure project deliverables are achieved and results are high quality
    • Provide technical leadership in assay and reagent QC methods and process development
    • Coach and support team members to ensure best practice in the execution of product development projects
    • Participate in project-specific technical discussions with external parties as needed
    • Develop and maintain effective working relationships with contract research and manufacturing organizations as needed
    • Oversee remedial action and troubleshooting to support manufacturing, QC and technical support as needed

     

    Skills and Experience:

    • Ph.D. or M.S. in a Physical or Life Sciences discipline
    • Minimum of 6 years of relevant experience and IVD industry experience in molecular diagnostics assay development, experience with bacterial pathogens a plus.
    • Demonstrated technical, managerial, and leadership expertise in assay development
    • Development experience in FDA-approved products
    • Experience with one or more of the following:  QC test method development, reagent formulation development and optimization, materials and formulated reagent QC or process development for reagents and controls
    • A strong work ethic and ability to generate high quality work under tight deadlines
    • Demonstrated management skills and self-motivation
    • Ability to motivate and guide others to meet objectives

    To apply, please go to www.t2biosystems.com and send your résumé and cover letter through our careers  portal. 


    0 0

    T2 Biosystems, founded in 2006 by renowned scientists from MIT and Mass General Hospital, is an in vitro diagnostic company that has developed an innovative and proprietary technology platform that offers a rapid, sensitive and simple alternative to existing diagnostic methodologies.     We are using our T2 Magnetic Resonance platform, or T2MR, to develop a broad set of applications aimed at reducing mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier.  T2MR enables rapid detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, and can detect cellular targets as limits of detection as low as one colony forming unit per milliliter, or CFU/ml.  Our initial development efforts utilizing T2MR target sepsis and hemostasis, which are areas of significant unmet medical need in which existing therapies could be more effective with improved diagnostics. We have completed a pivotal clinical trial for our T2Dx diagnostic instrument, or T2Dx, and T2 Candida panel, or T2Candida, which have the ability to rapidly identify the five clinically relevant species of Candida, a fungal pathogen known to cause sepsis.

    On September 22, 2014, T2 Biosystems received market authorization from the U.S. Food and Drug Administration (FDA) for its first two products, the T2Candida® Panel and the T2Dx® Instrument for the direct detection of Candida species in human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. T2Candida and T2Dx, for the first time, provide sensitive detection of specific sepsis-causing pathogens directly from a whole blood specimen in approximately four hours. All other currently FDA-cleared detection systems require cultured blood samples for species-specific identification and take two to five days or more to provide results.

    T2 Biosystems was named to the FierceMedicalDevices "Fierce 15" list in 2012, received the prestigious SBANE award in 2013 and received the Most Promising Company award at the Personalized Medicine World Conference in 2014.

    We are seeking a talented and highly motivated individual to join our team as a Senior Systems Engineerreporting to the Vice President of Systems Engineering. 

    Responsibilities:

    • Design and development of mechanical and electromechanical subsystems.
    • Integrate and transfer new assays and assay components onto automated systems.
    • Design and development of consumables used with automated test systems.
    • Develop and refine specifications for consumable, instrument, software, and assay interfaces.
    • Development and execution of formal V&V testing and reports.
    • Generation of design documentation, especially control drawings.
    • Develop new tools and metrics for tracking the performance of automated assays and systems.
    • Provide mentoring for junior systems engineers

    Education and Required Skills:

    • B.S. in Engineering (Mechanical, Electrical or Chemical) with 3-7 years of experience depending on degree level
    • Knowledge of electromechanical systems test and control.
    • Knowledge of automated liquid handling, robotics, motion control, and thermal control systems.
    • Experience with FDA Design Controls.
    • Experience with Risk Management and ISO 14971.
    • Good understanding of system modeling and analysis.
    • Excellent written and oral communication skills. 

    The successful candidate will be highly motivated, results driven, exceptionally talented, analytical, and a team player.


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  • 12/28/15--00:07: Molecular Research Associate
  • If you are looking for an opportunity to join an incredibly fun, fast paced, and collaborative team please keep reading! Our client, a vibrant young startup, is seeking highly motivated, easily trainable and upbeat individual to join their team. You will have the chance to use your expertise in molecular cloning, tissue culture, protein expression, protein purification, and DNA, RNA and protein assay development. You will also have the chance to work beside incredibly talented scientists to create and conduct experiments.
    The ideal candidate will have the following:
    • Master’s Degree in a scientific discipline with at least 2-7 years of relevant experience
    • Molecular biology skills including: Western blot, PCR, ELISA, and protein purification
    •CRISPR/ Cas 9 experience a BONUS!
    Experience with viral vectors and Vector NTI software
    If this sounds like the right opportunity for you, apply today!
    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™


    0 0
  • 12/28/15--00:33: Medical Director
  • If you are an industry (biopharmaceutical) experienced individual with strong leadership qualities this is a not to be missed opportunity for you!

    Our client, a clinical development focused biopharmaceutical company in the Bay area is looking for an experienced Medical Director to join their team. This opportunity is at an extremely progressive & innovative company working on a very exciting science that will create an exponential increase in the quality of life for patients. This crucial role will give the right individual the opportunity to truly make a difference and orchestrate efforts to clinical trials with their on a quick path to NDA.

    For this high profile position, the selected individual will join a dynamic team in a cohesive, collaborative environment. The right individual should be comfortable facilitating recruitment efforts for the clinical operations group, engaging & relationship building with foundations and partners, and making sure protocols are followed as written.

    REQUIREMENTS:
    • MD degree
    • Industry experience
    • phase 3 experience preferred
    • Gastroenterology experience or Generalist
    • Willingness to collaborate and share innovative ideas throughout the company
    • Exhibit strong leadership qualities & handle day to day medical functions
    • Possess ability to build positive collaborative relationships and handle outreach to relevant foundations & partners

    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™


    0 0

    Senior Bioinformatics Scientist
    Location: Cambridge, MA

    Who We Are:

    Founded by pioneering scientists in fabrication, genetics, and bio-engineering, the Gen9 vision is one of democratizing synthetic biology. Our goal is to enable broad adoption of powerful synthetic biology techniques by providing custom DNA constructs of the highest possible quality. 

     

    Using our proprietary BioFab® platform, we make synthetic DNA easier to design, easier to use, and easier to access.  With our custom gene synthesis and library products, scientists can design more, build more, and test more.  We believe that synthetic biology will be the cornerstone of future advancements in therapeutics, clean technology, agriculture and many other industries, and we are excited to partner with our customers as we synthesize the future together.

     

    Position summary:


    Gen9 is looking for a senior bioinformatics scientist to develop software architecture for our next-generation DNA synthesis platform.  The ideal candidate will be comfortable with a range of responsibilities as a member of a small, efficient team.  

     

    Responsibilities:

     

    • Create and promote novel algorithms and solutions for cutting-edge high throughput DNA synthesis platform

     

    • Collaborate closely with laboratory scientists for experimental design and analysis toward new product development

     

    • Develop tools and pipelines ranging in context from individual scientist use to automated manufacturing processing

     

    • Plan, develop, implement, and validate new software solutions and technologies for the full application stack

     

    • Serve as knowledge source for bioinformatics domain information, providing guidance to other developers

     

    Requirements:

     

    • PhD / MS in bioinformatics, biophysics, computational biology, computer science, or related degree with 5+ years of industry experience, or equivalent combination of education and experience

     

    • Demonstrated proficiency with Python, C/C++, and Linux/Unix environments

     

    • Demonstrated expertise with bioinformatics algorithms and ability to vault beyond existing tools focused on genomics applications

     

    • Advanced ability in large-scale data analysis, particularly with next generation sequencing. 

     

     

    • Experience with some or all of the following technologies or equivalents:  SQL, SQLAlchemy, AWS

     

    • Experience with revision control systems (e.g. git), continuous integration, and task/issue trackers

     

    • Demonstrated ability to work effectively with minimal supervision in a small collaborative team and to multi-task and manage numerous activities simultaneously

     

    • Demonstrated ability to build constructive relationships within and across teams to facilitate collaboration, brainstorming and problem solving.   Ability to present information clearly and succinctly to a range of individuals.

     

    • Strong documentation skills

     

    HOW TO APPLY:

    Send resume & cover letter to: resumes@gen9bio.com.   Please briefly describe your skills, knowledge, and experience with the Required Qualifications in your cover letter/email.


    0 0

    Senior Bioinformatics Scientist
    Location: Cambridge, MA

    Who We Are:

    Founded by pioneering scientists in fabrication, genetics, and bio-engineering, the Gen9 vision is one of democratizing synthetic biology. Our goal is to enable broad adoption of powerful synthetic biology techniques by providing custom DNA constructs of the highest possible quality. 

     

    Using our proprietary BioFab® platform, we make synthetic DNA easier to design, easier to use, and easier to access.  With our custom gene synthesis and library products, scientists can design more, build more, and test more.  We believe that synthetic biology will be the cornerstone of future advancements in therapeutics, clean technology, agriculture and many other industries, and we are excited to partner with our customers as we synthesize the future together.

     

    Position summary:


    Gen9 is looking for a senior bioinformatics scientist to develop software architecture for our next-generation DNA synthesis platform.  The ideal candidate will be comfortable with a range of responsibilities as a member of a small, efficient team.  

     

    Responsibilities:

     

    • Create and promote novel algorithms and solutions for cutting-edge high throughput DNA synthesis platform

     

    • Collaborate closely with laboratory scientists for experimental design and analysis toward new product development

     

    • Develop tools and pipelines ranging in context from individual scientist use to automated manufacturing processing

     

    • Plan, develop, implement, and validate new software solutions and technologies for the full application stack

     

    • Serve as knowledge source for bioinformatics domain information, providing guidance to other developers

     

    Requirements:

     

    • PhD / MS in bioinformatics, biophysics, computational biology, computer science, or related degree with 5+ years of industry experience, or equivalent combination of education and experience

     

    • Demonstrated proficiency with Python, C/C++, and Linux/Unix environments

     

    • Demonstrated expertise with bioinformatics algorithms and ability to vault beyond existing tools focused on genomics applications

     

    • Advanced ability in large-scale data analysis, particularly with next generation sequencing. 

     

     

    • Experience with some or all of the following technologies or equivalents:  SQL, SQLAlchemy, AWS

     

    • Experience with revision control systems (e.g. git), continuous integration, and task/issue trackers

     

    • Demonstrated ability to work effectively with minimal supervision in a small collaborative team and to multi-task and manage numerous activities simultaneously

     

    • Demonstrated ability to build constructive relationships within and across teams to facilitate collaboration, brainstorming and problem solving.   Ability to present information clearly and succinctly to a range of individuals.

     

    • Strong documentation skills

     

    HOW TO APPLY:

    Send resume & cover letter to: resumes@gen9bio.com.   Please briefly describe your skills, knowledge, and experience with the Required Qualifications in your cover letter/email.


    0 0
  • 12/28/15--01:56: Inside Sales Representative
  • Inside Sales Representative

    Location: Cambridge, MA

     

    Who We Are:

    Founded by pioneering scientists in fabrication, genetics, and bio-engineering, the Gen9 vision is one of democratizing synthetic biology. Our goal is to enable broad adoption of powerful synthetic biology techniques by providing custom DNA constructs of the highest possible quality. 

     

    Using our proprietary BioFab® platform, we make synthetic DNA easier to design, easier to use, and easier to access.  With our custom gene synthesis and library products, scientists can design more, build more, and test more.  We believe that synthetic biology will be the cornerstone of future advancements in therapeutics, clean technology, agriculture and many other industries, and we are excited to partner with our customers as we synthesize the future together.

     

    Position Summary

    We are looking for a talented and competitive Inside Sales Representative who thrives in the kind of fast-paced environment that can only be found in a cutting-edge, early stage technology company.  The successful candidate will play a essential role in achieving our ambitious customer acquisition and revenue growth objectives.  The successful incumbent must be comfortable making dozens of calls per day, working with internal and field-based colleagues, generating and sustaining customer interest, qualifying prospects and closing sales.

     

    Responsibilities

    • Maintain, develop, and expand existing customer relationships, primarily in the academic vertical, to close sales and achieve quarterly quotas.  Research accounts, identify key players and generate interest.in Gen9’s unique synthetic biology portfolio

     

    • Source new sales opportunities through inbound lead follow-up and outbound cold calls and emails, performing effective online demos to prospects.  Route qualified opportunities to the appropriate sales representative for further development and closure.

     

    • Understand customer needs and requirements and provide consistent feedback to Sales and Marketing groups on Gen9’s success in meeting those needs and requirements.

     

    • Maintain and expand your database of prospects within your assigned territory.

     

     

    Requirements

    • BA/BS degree or equivalent in a life sciences discipline is required.
    • 2+ years of inside sales experience is required; experience in a headquarters-based customer service team is a plus.

     

    • Demonstrated track record of successfully and consistently achieving/ over-achieving quota is required.

     

    • 1-2 years’ experience working with Salesforce.com or similar CRM and demonstrated proficiency with corporate productivity and web presentation tools is required.

     

    • Strong verbal communication skills and phone presence required to successfully qualify leads, build and expand customer relationships, discuss and understand customer needs.  Requires persistence and commitment in dialing dozens of calls per day.

     

    • Demonstrated skill in listening to prospects and customers to understand their needs and translate into Gen9 requirements and demonstrated presentation skills to support online demos.

     

    • Demonstrated ability to multi-task, prioritize, and manage time effectively

     

    HOW TO APPLY:

    Send resume & cover letter to: resumes@gen9bio.com.   Please briefly describe your skills, knowledge, and experience with the Required Qualifications in your cover letter/email.


    0 0
  • 12/28/15--02:04: Quality Control Associate
  • T2 Biosystems, founded in 2006 by renowned scientists from MIT and Mass General Hospital, is an in vitro diagnostic company that has developed an innovative and proprietary technology platform that offers a rapid, sensitive and simple alternative to existing diagnostic methodologies.     We are using our T2 Magnetic Resonance platform, or T2MR, to develop a broad set of applications aimed at reducing mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier.  T2MR enables rapid detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, and can detect cellular targets as limits of detection as low as one colony forming unit per milliliter, or CFU/ml.  Our initial development efforts utilizing T2MR target sepsis and hemostasis, which are areas of significant unmet medical need in which existing therapies could be more effective with improved diagnostics. We have completed a pivotal clinical trial for our T2Dx diagnostic instrument, or T2Dx, and T2 Candida panel, or T2Candida, which have the ability to rapidly identify the five clinically relevant species of Candida, a fungal pathogen known to cause sepsis.

    On September 22, 2014, T2 Biosystems received market authorization from the U.S. Food and Drug Administration (FDA) for its first two products, the T2Candida® Panel and the T2Dx® Instrument for the direct detection of Candida species in human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. T2Candida and T2Dx, for the first time, provide sensitive detection of specific sepsis-causing pathogens directly from a whole blood specimen in approximately four hours. All other currently FDA-cleared detection systems require cultured blood samples for species-specific identification and take two to five days or more to provide results.

    T2 Biosystems was named to the FierceMedicalDevices "Fierce 15" list in 2012, received the prestigious SBANE award in 2013 and received the Most Promising Company award at the Personalized Medicine World Conference in 2014.

    We are seeking a talented and highly motivated individual to join our team as a Quality Control Associate.

     

    Responsibilities:

    • Ensuring the quality of incoming raw materials, in-process, stability and release testing of samples following SOPs, Work Instruction (WI) and GMP guidelines
    • Document all analysis following approved work instructions and GMP guidelines.
    • Assist with the maintenance of QA monitoring programs, such as internal audits.
    • Support new product development and continuous improvement by integrating QC tools and techniques.
    • Create and maintain required QC process documentation. Generate certificate of analysis.
    • Participate in lab investigations; respond to corrective and preventive actions related to laboratory investigations.
    • Support manufacturing and other lab operations.
    • Trouble shooting of equipment issues.
    • Other duties, which may be assigned, based on the need.

     

    Our ideal candidate will possess:

    • B.S. science related degree (such as Biochemistry, Molecular Biology, Biotechnology etc.) with 1-3 yrs. in an industry setting (in-vitro diagnostic environment a plus).
    • Understanding of molecular biology, assay development, and DNA diagnostic chemistry is highly desirable.
    • Experience in laboratory techniques such as RT-PCR, UV/VIS, and pH is highly desirable.
    • Understanding and awareness of cleanliness in a PCR laboratory to avoid contamination is required.
    • Strong analytical and problem solving skills.
    • High attention to detail adhering to regulatory guidelines.

    In addition, you will:

    Work in a team-based cross functional organization,

    Be highly self-motivated, an excellent communicator, highly analytical, and

    Have the ability to work in a fast-paced environment and maintain focus on deliverables

     

    To apply, please follow the link to our careers page at: http://www.t2biosystems.com/careers/

     

    T2 Biosystems is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, gender, pregnancy, national origin, age, military service eligibility, veteran status, sexual orientation, marital status, disability, or any other protected class.

     

     


    0 0
  • 12/28/15--02:05: Inside Sales Representative
  • Inside Sales Representative

    Location: Cambridge, MA

     

    Who We Are:

    Founded by pioneering scientists in fabrication, genetics, and bio-engineering, the Gen9 vision is one of democratizing synthetic biology. Our goal is to enable broad adoption of powerful synthetic biology techniques by providing custom DNA constructs of the highest possible quality. 

     

    Using our proprietary BioFab® platform, we make synthetic DNA easier to design, easier to use, and easier to access.  With our custom gene synthesis and library products, scientists can design more, build more, and test more.  We believe that synthetic biology will be the cornerstone of future advancements in therapeutics, clean technology, agriculture and many other industries, and we are excited to partner with our customers as we synthesize the future together.

     

    Position Summary

    We are looking for a talented and competitive Inside Sales Representative who thrives in the kind of fast-paced environment that can only be found in a cutting-edge, early stage technology company.  The successful candidate will play a essential role in achieving our ambitious customer acquisition and revenue growth objectives.  The successful incumbent must be comfortable making dozens of calls per day, working with internal and field-based colleagues, generating and sustaining customer interest, qualifying prospects and closing sales.

     

    Responsibilities

    • Maintain, develop, and expand existing customer relationships, primarily in the academic vertical, to close sales and achieve quarterly quotas.  Research accounts, identify key players and generate interest.in Gen9’s unique synthetic biology portfolio

     

    • Source new sales opportunities through inbound lead follow-up and outbound cold calls and emails, performing effective online demos to prospects.  Route qualified opportunities to the appropriate sales representative for further development and closure.

     

    • Understand customer needs and requirements and provide consistent feedback to Sales and Marketing groups on Gen9’s success in meeting those needs and requirements.

     

    • Maintain and expand your database of prospects within your assigned territory.

     

     

    Requirements

    • BA/BS degree or equivalent in a life sciences discipline is required.
    • 2+ years of inside sales experience is required; experience in a headquarters-based customer service team is a plus.

     

    • Demonstrated track record of successfully and consistently achieving/ over-achieving quota is required.

     

    • 1-2 years’ experience working with Salesforce.com or similar CRM and demonstrated proficiency with corporate productivity and web presentation tools is required.

     

    • Strong verbal communication skills and phone presence required to successfully qualify leads, build and expand customer relationships, discuss and understand customer needs.  Requires persistence and commitment in dialing dozens of calls per day.

     

    • Demonstrated skill in listening to prospects and customers to understand their needs and translate into Gen9 requirements and demonstrated presentation skills to support online demos.

     

    • Demonstrated ability to multi-task, prioritize, and manage time effectively

     

    HOW TO APPLY:

    Send resume & cover letter to: resumes@gen9bio.com.   Please briefly describe your skills, knowledge, and experience with the Required Qualifications in your cover letter/email.


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    Senior Bioinformatics Scientist
    Location: Cambridge, MA

    Who We Are:

    Founded by pioneering scientists in fabrication, genetics, and bio-engineering, the Gen9 vision is one of democratizing synthetic biology. Our goal is to enable broad adoption of powerful synthetic biology techniques by providing custom DNA constructs of the highest possible quality. 

     

    Using our proprietary BioFab® platform, we make synthetic DNA easier to design, easier to use, and easier to access.  With our custom gene synthesis and library products, scientists can design more, build more, and test more.  We believe that synthetic biology will be the cornerstone of future advancements in therapeutics, clean technology, agriculture and many other industries, and we are excited to partner with our customers as we synthesize the future together.

     

    Position summary:


    Gen9 is looking for a senior bioinformatics scientist to develop software architecture for our next-generation DNA synthesis platform.  The ideal candidate will be comfortable with a range of responsibilities as a member of a small, efficient team.  

     

    Responsibilities:

     

    • Create and promote novel algorithms and solutions for cutting-edge high throughput DNA synthesis platform

     

    • Collaborate closely with laboratory scientists for experimental design and analysis toward new product development

     

    • Develop tools and pipelines ranging in context from individual scientist use to automated manufacturing processing

     

    • Plan, develop, implement, and validate new software solutions and technologies for the full application stack

     

    • Serve as knowledge source for bioinformatics domain information, providing guidance to other developers

     

    Requirements:

     

    • PhD / MS in bioinformatics, biophysics, computational biology, computer science, or related degree with 5+ years of industry experience, or equivalent combination of education and experience

     

    • Demonstrated proficiency with Python, C/C++, and Linux/Unix environments

     

    • Demonstrated expertise with bioinformatics algorithms and ability to vault beyond existing tools focused on genomics applications

     

    • Advanced ability in large-scale data analysis, particularly with next generation sequencing. 

     

     

    • Experience with some or all of the following technologies or equivalents:  SQL, SQLAlchemy, AWS

     

    • Experience with revision control systems (e.g. git), continuous integration, and task/issue trackers

     

    • Demonstrated ability to work effectively with minimal supervision in a small collaborative team and to multi-task and manage numerous activities simultaneously

     

    • Demonstrated ability to build constructive relationships within and across teams to facilitate collaboration, brainstorming and problem solving.   Ability to present information clearly and succinctly to a range of individuals.

     

    • Strong documentation skills

     

    HOW TO APPLY:

    Send resume & cover letter to: resumes@gen9bio.com.   Please briefly describe your skills, knowledge, and experience with the Required Qualifications in your cover letter/email.


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    T2 Biosystems, founded in 2006 by renowned scientists from MIT and Mass General Hospital, is an in vitro diagnostic company that has developed an innovative and proprietary technology platform that offers a rapid, sensitive and simple alternative to existing diagnostic methodologies.     We are using our T2 Magnetic Resonance platform, or T2MR, to develop a broad set of applications aimed at reducing mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier.  T2MR enables rapid detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, and can detect cellular targets as limits of detection as low as one colony-forming unit per milliliter, or CFU/ml.  Our initial development efforts utilizing T2MR target sepsis and hemostasis, which are areas of significant unmet medical need in which existing therapies could be more effective with improved diagnostics. We have completed a pivotal clinical trial for our T2Dx diagnostic instrument, or T2Dx, and T2 Candida panel, or T2Candida, which have the ability to rapidly identify the five clinically relevant species of Candida, a fungal pathogen known to cause sepsis.

    On September 22, 2014, T2 Biosystems received market authorization from the U.S. Food and Drug Administration (FDA) for its first two products, the T2Candida® Panel and the T2Dx® Instrument for the direct detection of Candida species in human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. T2Candida and T2Dx, for the first time, provide sensitive detection of specific sepsis-causing pathogens directly from a whole blood specimen in approximately four hours. All other currently FDA-cleared detection systems require cultured blood samples for species-specific identification and take two to five days or more to provide results.

    T2 Biosystems was named to the FierceMedicalDevices "Fierce 15" list in 2012, received the prestigious SBANE award in 2013 and received the Most Promising Company award at the Personalized Medicine World Conference in 2014

    We are seeking a talented and highly motivated individual to be part of our Reagent Development Team as a Manufacturing Technician-Contract. This position reports directly to the Senior Development Scientist

    The successful candidate will be responsible for supporting T2 Bacteria and T2 Lyme manufacturing processes from material receipts through shipments including, but not limited to: inventory control, training, formulations, filling, and maintenance of GMP compliance.

    Responsibilities will broadly include:

    • Complete batch records, WOs, and associated production documentation with attention to detail and quality.
    • Assist in the management of inventory, including receipt and inspection of materials.
    • Report any deviations and non-conformances to Manager to ensure proper documentation.
    • Support the scale up to commercialization.
    • Support Verification Panel and other T2Candida internal requests.
    • Performs other duties as assigned.

    Required Experience:

    • Bachelor’s degree in Biology, Chemistry, or related field or comparable industry experience
    • 0-2 years industry experience
    • Experience in a regulated environment, GMP, ISO, FDA, and Aseptic techniques is desired

    In addition, you must have:

    • Excellent organizational, record keeping and communication skills (oral and written)
    • A strong work ethic to generate high quality work under tight deadlines, collaborative and proactive attitude a must
    • Self starter and able to work in a fast-paced environment within a matrix organization
    • A desire to get a product to market

    The successful candidate will be highly motivated, results driven, exceptionally talented, analytical, and a team player.

    To apply, please follow the link to our careers page at: http://www.t2biosystems.com/careers/

    T2 Biosystems is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, gender, pregnancy, national origin, age, military service eligibility, veteran status, sexual orientation, marital status, disability, or any other protected class.

     


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    Org Marketing Statement
    A career at Pfizer offers opportunity, ownership and impact.

    All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

    Role Description
    The Lab Head for GPCR Signaling and Target Identification will be responsible for leading a group of 3 - 5 scientists and postdoctoral fellows working to develop and implement tools for GPCRs and identify and validate new targets for CNS disease relevant to the Neuroscience and Pain Research Unit's therapeutic areas of interest.

    Responsibilities
    * Develop new capabilities to assess GPCR signaling and how these are modulated by compounds of interest
    * Identify and validate new targets and mechanisms in the context of CNS disease.
    * Assess GPCR targets in human disease models, developing an integrative approach to CNS disease that includes bioinformatics, genetics, cellular, molecular and circuit neurobiology.
    * Work closely with human biologists in the Neuroscience and Pain and other Research Units to translate assays in animal models to humans.
    * Be a clear thinker, dynamic speaker and a scientifically focused, visible leader in academics or industry, and develop research interests in the lab they lead.
    * Maintain and engage a strong external network of collaborators, and engage ongoing international collaborations.
    * Publish world class, cutting edge research in top tier scientific journals.
    * Develop an interactive scientific environment which engages colleagues across the Neuroscience and Pain Research Unit, and contributes to projects across the Unit.

    Qualifications
    * Ph.D., M.D. or M.D./Ph.D.
    * 3+ years of postdoctoral research experience
    * Track record of leading a scientific team in academia or industry
    * 2-5 years industry experience preferred
    * Established record of high quality scientific research and publications in top tier journals
    * Established national and emerging international scientific reputation
    * Experience in mentoring junior scientists and postdoctoral fellows
    * Deep insight and knowledge of GPCR biology and CNS disease
    * Comprehensive knowledge of cutting edge cellular and circuit targets in neurons, glia and other CNS cells
    * Able to implement emerging technologies and approaches

    EEO & Employment Eligibility
    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

    Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy4wNDUwNC4zMTY3QHBmaXplci5hcGxpdHJhay5jb20


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  • 12/29/15--01:17: MD Monitor / MD Oncology
  • Senior MD Consultant with Oncology Trial experience.

    Various Senior Level Consulting roles: Medical Monitor / Senior MD Oncology Consultant

    Aid in the development of clinical strategy by providing strategic input and assistance in development activities where applicable; interface with KOLs and CROs as required.

    Consultant will also assist with various areas of of clinical trial expertise : including strategy, and assisting in preparation for Pre-IND meeting and IND submission.


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    Senior Regulatory Affairs Consultant

    Director level Pharma Industry experience

    Provide Non-Clinical and Clinical consulting support in areas of Quality, Regulatory and CMC with specific deliverables including, strategic input, Quality System Development, SOP Development and vendor qualifications/audits for various programs.   Weekly work will approximate 8-15 hours.


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    The Receptionist/Event Coordinator is primarily responsible for the timely and professional handling of visitors and callers to Anika Therapeutics. The position will provide process support for Quality Systems, Finance and Human Resources as well as general administrative support for other departments as needed

    Entry level position, ideal for a recent college graduate looking to learn and grow!

    Required Qualifications:

    • Bachelor’s degree in the Business or related field or relevant equivalent experience
    • 1-2 years of experience within the private sector
    • Professional verbal communication skills and personal presentation
    • Demonstrated proficiency with Microsoft Office suite, specifically Word, Excel and PowerPoint

    Click on company link below to apply!

    http://www.anikatherapeutics.com/careers/explore-jobs/posting/receptionist/

     


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    Title: Sales Manager

    Territory: East coast US

    Company Overview:   Our client, a world leader in the development of bioinformatics software, has developed a core software engine that visualizes high dimensional data sets in 3D to identify hidden structures and patterns in real time. This tool enables researchers to more clearly interpret bioinformatic data to enable drug discovery and development.  Our client partners with organizations including academic researchers, pharma, biotech, non-profits, and government labs across numerous disease indications.   Our client has clients in over 25 countries and the software tools have been utilized in more than 250 client publications.

    Position Description:  Our client is looking for a highly motivated entrepreneurial sales professional with proven success selling into research markets. This position is preferably based in the Boston area, but potentially could be located in other life sciences hubs on the east coast.  This position will focus on US market expansion and will be the first full time sales hire in the US. This role is ideal for a self-starter who can seamlessly manage their time, deliverables, and customer expectations.  The individual hired will be responsible for developing and expanding customer relationships, developing sales and revenue forecasts, and managing their territory.  The individual hired should be familiar with selling into academic labs as well as pharma, biotech, non-profits and government labs and be comfortable selling informatics based solutions. Knowledge of bioinformatics analysis tools is required. The position will require travel to client sites and periodic travel to the main office in Sweden.  This is an exciting opportunity to join a dynamic, growing European company.

     

    Position Requirements:

    • Master of science, preferably with a big data analysis focus, in an area such as bioinformatics, mathematics, physics, statistics, biophysics or related area. 
    • Familiarity with genomic and proteomic bioinformatic tools is required.   
    • Software sales or field application specialist background with > 3+ years of experience selling / supporting software solutions into the preclinical and /or clinical research markets.
    • Consultative sales background with experience doing live software demonstrations to small and large groups.
    • Experience managing all steps of the sales process, from lead generation to account management of existing customers. 
    • Success building relationships across all levels of an organization
    • Proven ability to thrive in an entrepreneurial environment.  International experience is a plus
    • Good technical understanding of software and computers
    • The work will involve travel both domestically and internationally, anticipated at 40% travel.

     


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    GENERAL SUMMARY OF POSITION:

     

    The Associate Deputy Director, Regulatory Affairs is responsible to develop and oversee strategic approaches to ensure that MassBiologics' IND and licensed products meet regulatory agency requirements and industry current practices both nationally and internationally.

    MAJOR RESPONSIBILITIES:

    • Designated as MassBiologics' authorized representative to the US FDA and international regulatory agencies as applicable.
    • Leads negotiations as primary liaison with regulatory agencies.
    • Responsible for establishing fiscally responsible organizational strategy to ensure regulatory compliance in all jurisdictions where MassBiologics places its products as well as strategies to support CMO client products.
    • Ensures that all aspects of MBL-sponsored clinical trials meet regulatory requirements. Set and prioritize project timelines.
    • Manages the coordination and preparation of document packages for all regulatory submissions, internal audits and FDA inspections. Includes, but is not limited to, Biologic License Applications and Amendments (BLAs), Establishment License Applications and Amendments (ELAs), Investigational New Drug (IND) Applications and Amendments, responses to all FDA queries and inspections, labeling Transmittals for Product Labels, Circulars and Promotional and Advertising Materials.
    • Oversees all regulatory submissions, license applications, and renewals required by regulatory agencies. Ensures that the proper documents have been compiled and submitted.
    • Oversees regulatory document tracking systems and initiates new and improved tracking systems to meet organization's goals
    • Provides input to the MassBiologics Quality System by providing technical input to the deviation and change management processes to assure consistency with current regulatory status or to initiate an appropriate regulatory submission.
    • Recommends changes for labeling, manufacturing, marketing and clinical protocols for regulatory compliance and ensures the changes are completed.
    • Maintains current knowledge of all applicable regulations. Responsible for circulating information to Senior Staff. Provides expert analysis and evaluation of regulations. Evaluates risk, impact and analyzes trends of government regulatory activities.
    • Ensures that reports of Adverse Events are documented appropriately, circulated to appropriate personnel, tracked internally and submitted to FDA as needed. Submit Periodic Adverse Event Report for all licensed products every January.
    • Prepares and submits annual reports for active IND products and BLAs.
    • Directs Clinical Trials Operations ensuring that clinical trials are executed in accordance with MassBiologics strategy, scientific plan and Good Clinical Practices.
    • Ensures that all aspects of MBL-sponsored clinical trials meet regulatory requirements. Set and prioritize project timelines.
    • Performs additional job related duties as required

    REQUIRED QUALIFICATIONS:

    • Requires a doctorate degree (PhD, MD) and demonstrated senior leadership experience or a Bachelor's degree and 15 years experience including senior management experience. Prior experience as a senior leader of regulatory affairs for a Biologics Manufacturing organization is required.
    • Demonstrated ability to effectively manage: processes, others, performance, and set and prioritize departmental goals
    • Excellent time management and organizational skills, demonstrated ability to manage and prioritize multiple teams, multiple projects and meet deadlines
    • Excellent written and verbal communication skills
    • Excellent customer service skills
    • Experience in any of the following areas preferred: IND submissions, BLA submissions and ELA applications/amendments, submissions to regulatory agencies in other countries
    • May require frequent travel between the Mattapan and Fall River campuses
    • May require national and international travel
    • Ability to work extended and sometimes unusual hours to meet business needs.

    Must be able to carry out the essential functions of this position, with reasonable accommodation if disabled



    Apply Here

    PI92607706


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