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Career postings for the Massachusetts Biotechnology Council

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    Primary Duties:

    This position has two primary responsibilities:
    1. Global Health Economics (GHE) Center of Excellence related responsibilities. Function as an Health economic (HE) expert to provide expertise in the design, analysis and dissemination plan(s) of GHE data
    2. Global Health Economics , Outcomes Research and Epidemiology (GHEORE) Product (s) lead responsibility for the coordination and articulation of the integrated GHEORE global product strategy and representation of GHEORE in the company wide product related working groups (Global Value Team (GVT), product development team (PDT), DDT etc.)

    Responsibilities:

    40%
    GHE Center of Excellence Responsibilities
    * Propose, develop and implement GHE studies agreed upon by the GVT in order to maximize commercial opportunities for Shire products
    * Lead the design and execution of GHE studies
    * Ensure effective, efficient and timely execution of GHE deliverables
    * Contribute and collaborate during the product strategy development process and plans for dissemination of HE data
    * Proactively contribute and support the GHEORE Therapeutic Area (TA)/BU lead(s) in the development of the global product strategy and the implementation of the GHE agreed upon deliverables.
    * Provide professional HE consultation to GHEORE Product Leads or other department members (non economists) on HE projects/deliverables regarding strategic or methodological issues related to HE, when needed
    * Ensure the scientific quality and integrity of all GHE projects to which you contribute either as a lead or as an advisor

    40%
    Product Lead responsibilities
    * Coordinate and contribute to the development of GHEORE global product strategy in support of:
    * Drug development and commercialization programs
    * Go/no go decisions for product candidates
    * Market access plans for global markets and global reimbursement strategy
    * Represent and garner support for the GHEORE product strategy within Shire's product teams such as the GVT, PDT and product marketing teams as necessary.
    * Be the point person for the assigned product(s) across the company for all GHEORE related issues including product strategy, deliverables and a reference point for all problems facing the product team related to GHEORE for the specific product
    * The GHEORE proposed product strategy will by its nature be comprehensive and interdisciplinary including PRO, HE, EPI and OR. The product lead is responsible for :
    * Leading a GHEORE product team
    * Ensuring that the product global strategic needs are identified and addressed by obtaining input from the product teams and the GHEORE product team members from all GHEORE centers of excellence
    * Engaging the GHEORE product team members and coordinating and monitoring the execution of the plan
    * Communicating and collaborating effectively with GHEORE product team members

    10%
    Leadership & managerial responsibilities

    10%
    Maintain awareness of global HEOR requirements, regulatory legislation, payers and HTA trends & requirements
    * Follow and review current professional literature in order to keep current regarding changing requirements and developing trends in HTA and other reimbursement authorities
    * Follow the HE literature

    Education and Experience Requirements
    Masters degree in Health Economics, Pharmacoeconomics, decision sciences (or similar) with 7 or more years experience in global biopharmaceutical or medical device industry or PhD in Health Economics, Pharmacoeconomics, decision sciences (or similar) with at least 5 years experience.

    Experience in interfacing with internal cross-functional decision making teams, external scientific bodies, & preference for experience with interactions with reimbursement agencies globally.

    Other Job Requirements
    Travel will be required (up to 20%)
    Experience and willingness to work in a global environment is essential
    Recruitment, management, development, and retention of health economists

    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 accommodatio

    Application URL:http://www.aplitrak.com/?adid=amRpZXR6Ljc3NDY3LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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    Org Marketing Statement
    All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

    Role Description
    The Muscle Metabolism group in the CVMED research unit seeks a talented and driven postdoctoral fellow to participate in the Pfizer WRD Postdoctoral Program. The successful candidate will work with mentors and Pfizer colleagues to define and perturb metabolic pathways in diabetic skeletal muscle, seeking to characterize the metabolic adaptations that occur in the diabetic state and identify novel sites of therapeutic intervention and future drug targets for T2DM. Under the guidance of research mentors, the successful candidate will drive the project forward with individual effort and independent study.

    Responsibilities
    The successful candidate will be required to:
    * Under the guidance of mentors, design and implement studies and interpret results
    * Effectively communicate and present data and concepts at internal and external forums
    * Obtain and publish key results in a timely manner
    * Develop independent research ideas and implement them

    Qualifications
    PhD in one of the following or an equivalent field: Molecular biology, biochemistry, pharmacology, physiology, cell biology.

    * Experience with skeletal muscle models is preferred: in vivo, ex vivo, or in vitro
    * Experience with stable isotope assisted metabolic flux analysis and familiarity with cellular metabolism work is preferred
    * Expertise with standard molecular biology techniques is required, including: western blots, elisas, qPCR, enzymatic metabolite quantification.
    * Familiarity with Adeno-Associated Virus or other viral mediated gene delivery is preferred
    * Experience with rodent models of T2DM and standard rodent handling and methods is preferred, including: GTT, blood collection, rodent IP, IV, SC, and PO dosing.

    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.

    Sunshine Act
    Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

    Application URL:http://www.aplitrak.com/?adid=ZWRkeS5uaWNvbGFzLjY3MzIxLjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


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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 successful candidate will be responsible for leading the in vivo pharmacology platform to support the development of novel therapeutic agents for the cardio-renal syndrome. This individual will be a key contributor to the cardiovascular group and utilize scientific and hands-on expertise in cardio-renal physiology and animal models of disease to advance an innovative drug discovery portfolio. The successful candidate will thrive in a fast paced and goal oriented, project team environment with unique opportunities for scientific and professional development.

    Responsibilities
    -Lead the development of the in vivo pharmacology platform to support the execution of the drug development strategy in the area of cardio-renal disease.
    -Design and execute pre-clinical in vivo studies to test the efficacy of novel compounds for heart failure and kidney disease, enabling progression of assets from pre-clinical to clinical development stage.
    -Contribute to the target identification and validation effort supporting the development of novel therapeutic approaches to the cardiorenal syndrome.
    -Conduct analysis of in vivo study data, including in-life data (cardiac/renal function and tissue remodeling endpoints), and data derived from ex vivo measurements (biomarkers, histology and biochemistry endpoints, function endpoints); present study results at internal and external meetings.
    -Provide expert training to junior scientists

    Qualifications
    -PhD in pharmacology, physiology or related field with 4+ years laboratory experience; industry experience preferred.
    -Strong hands-on expertise in performing surgical procedures in rodents including subtotal nephrectomy, coronary artery ligation, ischemia-reperfusion injury in heart and kidney, and aortic constriction. Experience with compound dosing through intravenous, intraperitoneal, subcutaneous and oral gavage routes.
    -Deep understanding of cardio-renal physiology in humans and animals and ability to apply scientific knowledge of the cardio-renal system in the design of pre-clinical in vivo studies to test efficacy of therapeutic agents.
    -Excellent communication, presentation and writing skills with an ability to multitask and troubleshoot. Strong organizational skills and attention to detail in the conduct of hands-on experiments and generation of data. Strong record of scientific accomplishment.
    -Effective project leadership skills built on collaboration with partner lines, vendors, and external experts to impact goals. Ability to work in a fast-paced environment and meet aggressive timelines. Team player.

    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=amVmZnJleXN0b25lLjg1NTM5LjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


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    ovartis Institutes for BioMedical Research (NIBR) is seeming a Highly motivated molecular biologist with significant flow cytometry background and expertise to join our Oncology Team

    This Scientist will be responsible for flow cytometry and other cell-based assay development to support oncology preclinical and clinical research programs and help assess and drive novel technologies, including assays centered on multi-parametric cell analysis.  

    ADDITIONAL REQUIREMENTS

    • PhD in molecular biology, immunology, or relevant scientific field with 2 years plus experience in an industrial or academic setting.
    • Significant experience and knowledge in operation of modern flow cytometry and cell sorting platforms and associated data systems including knowledge and application of sample preparation methodologies as applied to flow cytometry techniques.
    • Set up and validate FACS-based assays as well as analyze cell populations and operate a FACS sorter.
    • Responsible for maintenance of FACS laboratory equipment and supplies.
    • Experience and thorough knowledge of molecular biology techniques such as tissue culture, western blot analysis, FISH, and DNA/RNA analysis is highly desirable. 
    • Excellent written and oral skills to be able to analyze results and provide oral and written reports to Lab Head and group meetings.
    • Follow scientific literature and demonstrate initiative for new approaches and innovative technical solutions.
    • Independently adapt and troubleshoot technical protocols according to experimental needs and work with lab head on experimental conduct and data analysis.
    • Provide support to other research associates and labs.

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    First Light Biosciences is developing breakthrough automated medical diagnostic products for rapid, sensitive, automated, and cost-effective detection of the microbes that cause hospital infections. The products address the key medical need to rapidly determine the right antibiotic to cure these life-threatening infections. Based on its proprietary MultiPath™ digital imaging technology, First Light’s products will combine the performance of the most advanced automated commercial laboratory tests with unprecedented affordability and ease-of-use. First Light Biosciences is a well-funded Bedford MA company offering a stimulating environment with a culture of excellence in science, engineering, and business.

    Job description

    Successful candidates will work collaboratively with and be trained by our experienced scientists. You will be part of an integrated interdisciplinary team developing powerful new medical diagnostic products using advanced immunochemical, nanoparticle, and digital imaging technology for rapid detection of microbial pathogens.  The laboratory work will support the development and validation of high performance immunoassays and will also include analysis using microbiological culture methods.

    Required Skills

    • · Strong microbiological culture (including sterile technique) and/or immunoassay techniques
    • · Broad laboratory and experimental skills
    • · Self-motivated, organized, able to prioritize and organize time effectively
    • · Excellent record keeping, written and oral skills
    • · Highly organized, attention to detail, completes assigned tasks on time
    • · Proactively communicate with supervisor and team
    • · Motivated to find ways to improve personal and company efficiency

    Required Experience/Education

    • · BS in a life science field with >2 years industry experience
    • · Industry experience using microbiology and/or antibody-based methods
    • · Experience following standard operating procedures
    • · Must be authorized to work in the U.S.

    Competitive salary and benefits.  Title and compensation depends on experience and education.

    Please apply by email only to jobs@firstlightbio.com. To insure proper processing include the Job Code RANOV15MBC in the subject line of the email.


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    First Light Biosciences is developing breakthrough automated medical diagnostic products for rapid, sensitive, automated, and cost-effective detection of the microbes that cause hospital infections. The products address the key medical need to rapidly determine the right antibiotic to cure these life-threatening infections. Based on its proprietary MultiPath™ digital imaging technology, First Light’s products will combine the performance of the most advanced automated commercial laboratory tests with unprecedented affordability and ease-of-use. First Light Biosciences is a well-funded Bedford MA company offering a stimulating environment with a culture of excellence in science, engineering, and business.

    Job description

    We are seeking a senior scientist or principal scientist with a strong background in in-vitro diagnostic assay development. You will be part of an integrated interdisciplinary team developing powerful new medical diagnostic products using advanced immunochemical, nanoparticle, and digital imaging technology for rapid detection of microbial pathogens. As the leader of a group with several research associates developing one of the company’s infectious disease tests, you should be a results-focused, team-oriented, bench scientist. The job responsibilities center on the design, development, optimization and validation of diagnostic assays.

    Responsibilities:

    • Design, optimize and validate the assays for multiple projects
    • Develop and apply rational design techniques to optimize key parameters of assay development
    • Serve as a technical expert in immounoassays and/or microbiological technologies within the organization and provide support to multiple projects
    • Identify, manage and contribute to external collaborations relevant to the program
    • Maintain accountability for project success and results delivery
    • Contribute to scientific and strategy discussions to advance and enhance the platform and assay candidates
    • Communicate research and development findings internally and externally
    • Supervise junior scientists working in the team

    Required Skills

    • Strong in experimental design, scientific analysis, critical thinking, trouble shooting abilities
    • Outstanding communication skills
    • Strong leadership and  management skills
    • Ability to multi-task to meet aggressive timelines, and technology development goals
    • Strong microbiological, protein chemistry, and immunological methods skills
    • Ability to think critically and creatively as part of a fast-paced research team
    • Strong project management skills
    • Highly organized, attention to detail, attains project milestones on time
    • Motivated to find ways to improve personal, team, and company efficiency
    • Ability to develop clear work instructions and test plans

    Required Experience/Education

    • PhD or MA in a life sciences field
    • A track record of successful IVD development including >3 years industry experience
    • Should have taken products through regulatory approval and launch
    • Industry experience using microbiology and/or antibody-based methods
    • Experience working under a quality system designed to meet FDA requirements
    • Strong background and experience in microbiology and immunoassays are preferred
    • Clinical microbiology laboratory experience a plus
    • Project management experience in an industry setting
    • Experience in supervising direct reports
    • Must be authorized to work in the U.S.

    Position type: Full-time

    Competitive salary and benefits.  Title and compensation depends on experience and education.

    Please apply by email only to jobs@firstlightbio.com. To insure proper processing include the Job Code SSNOV15MBC in the subject line of the email.


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    First Light Biosciences is developing breakthrough automated medical diagnostic products for rapid, sensitive, automated, and cost-effective detection of the microbes that cause hospital infections. The products address the key medical need to rapidly determine the right antibiotic to cure these life-threatening infections. Based on its proprietary MultiPath™ digital imaging technology, First Light’s products will combine the performance of the most advanced automated commercial laboratory tests with unprecedented affordability and ease-of-use.

    First Light Biosciences is a well-funded Bedford, MA company offering a stimulating environment with a culture of excellence in science, engineering and business.

    The Principle Software Engineer will lead our software team developing novel products based on First Light’s powerful new technology.

    Responsibilities:

    • Lead the software design and development of our automated analyzer instrument including robotics control and scheduling, system diagnostics, image analysis, user interface, data base storage and reporting, and external laboratory information system interface.
    • Work closely with an interdisciplinary engineering team and assay development scientists.
    • Oversee analyzer software and system integration, verification, validation, and manufacturing transfer.

    Qualifications:

    • Principle engineer; BS in Computer Science or related engineering discipline.
    • At least 10 years’ experience developing automated medical diagnostic platforms.
    • Demonstrated success leading the development of robust software for mission critical systems.
    • At least 5 years’ experience in Java development.
    • Demonstrated ability to develop innovative solutions and make sound design decisions in complex products.
    • Experience with agile development methodologies.
    • Familiarity with development for Linux platforms and embedded processors preferred.

    Position type: Full-time

    Competitive salary and benefits. Title and compensation depend on experience and education

    Please apply by email only to jobs@firstlightbio.com. To ensure proper processing include the Job Code PSENOV15MBC in the subject line of the email.


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    First Light Biosciences is developing breakthrough automated medical diagnostic products for rapid, sensitive, automated, and cost-effective detection of the microbes that cause hospital infections. The products address the key medical need to rapidly determine the right antibiotic to cure these life-threatening infections. Based on its proprietary MultiPath™ digital imaging technology, First Light’s products will combine the performance of the most advanced automated commercial laboratory tests with unprecedented affordability and ease-of-use.

    First Light Biosciences is a well-funded Bedford, MA company offering a stimulating environment with a culture of excellence in science, engineering, and business.

    The Program Manager will achieve program objectives in alignment with BARDA contract, budget and timeline while implementing First Light’s powerful new technology.

    Responsibilities:

    • Responsible for leading large, complex product development efforts that consist of one or more programs for a specific platform
    • Responsible for planning, scheduling and tracking progress to program milestones and managing the team through conflict and project constraints
    • Responsible for planning, conducting and documenting bi-weekly program status meetings with government contracting agency (BARDA)
    • Responsible for providing  written monthly program status, agenda and meeting reports to BARDA
    • Act as primary contact for program team related information
    • Facilitate program team meetings, cross-functional communication and decision making
    • Ensure alignment with internal and external stakeholders
    • Responsible for coordinating all aspects of program development from the start of the Concept or Definition Phase through successful completion of the Launch Phase and Program closeout (i.e. commercialization and transition of product into normal business operations or Life Cycle Management processes)
    • Lead the team in achieving cost, schedule, and performance goals of the program, including commercial success

     Required Experience and Education:

    • Bachelor's Degree; Master’s in technical field or MBA preferred
    • PMI certification or equivalent desired
    • Ten or more years of program leadership in product development with progressively increasing complexity of assignments
    • Experience in a regulated environment; preferably a medical device, biotechnology or pharmaceutical company
    • Knowledge of:
      • Product Development Phase Gate Methodology
      • Product Development Performance Metrics
      • Sigma Methodology e.g. DFSS DIMAC desired
      • Project Management Methodology

    Position type: Full-time

    Competitive salary and benefits. Title and compensation depend on experience and education

    Please apply by email only to jobs@firstlightbio.com. To ensure proper processing include the Job Code PMNOV15MBC in the subject line of the email.


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    Takeda is seeking a Consultant to join them for a 6 month assignment, with the possibility of extension.  Interested candidates may email resumes directly to Jaclyn.Keefe@takeda.com for immediate consideration.

    OBJECTIVE: 

    The purpose of this position is to provide compound level / development phase statistical expertise and leadership by:

    • Independently designing, analyzing and interpreting clinical studies at a compound level for early phase or less complex programs.
    • Providing strategic statistical input for feasibility assessments, development plans, cross-study analyses and regulatory submissions.
    • Improving and using standards to maximize global data integratability, interpretability and compound level efficiency
    • Leveraging internal and external resources to achieve quality, timely and cost-effective compound level and submission deliverables.
    • Independently representing Statistics function in interactions with regulatory authorities.

     

    ACCOUNTABILITIES: 

    • Independently represent statistics function on global teams in support of clinical studies and compound level programs.
    • Provide strategic statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions. Negotiate timelines (statistical) at compound level.
    • Plays a leadership role in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.
    • Oversee definition and implementation of compound-level database (including derived database), analysis and reporting standards.  Improve or use existing standards to ensure maximization of global integratibility and interpretability of data and enhance efficiency at compound level.  Coordinate with Data Management, Programming, Clinical and PV to target high quality databases and specifications at compound level.
    • Plan and direct compound level analysis and reporting activities (eg, tables, listings, graphs) including work of other statisticians and programmers.
    • Identify compound level vendor requirements and participate in the evaluation/selection of vendors. Provide compound level analytical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
    • Identify and interact with external statistical experts for issues related to study design, methodology and results.
    • Anticipate and communicate internal and external resource and quality issues that may impact deliverables or timelines of the compound level program.  Propose and implement solutions. Escalate issues to management as appropriate in a timely manner.
    • Lead the implementation of department standards and process improvements.
    • Lead evaluation and implementation of alternative analysis methodology and data presentation techniques.
    • Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analysis methods, and implement innovative approaches at a compound level.

     

    EDUCATION, EXPERIENCE AND SKILLS: 

    • Generally requires MA in statistics or biostatistics with at least 5 years of relevant experience or MS in statistics or biostatistics with at least 7 years of relevant experience. 
    • Experience with advanced study design or at least one NDA/CTDs or other global regulatory submissions.
    • Advanced knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics.
    • Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents.
    • Extensive knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
    • Good knowledge of statistical programming languages (including SAS), software, techniques, and processes. Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS (e.g., Microsoft OfficeÒ products).
    • Excellent oral and written communications skills.
    • Strong project management skills.
    • Strong collaborative skills and ability to work with a cross-functional team.

     

    PHYSICAL DEMANDS: 

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    • Ability to sit and stand for long periods of time.
    • Carrying, handling and reaching for objects.
    • Ability to lift and carry over 25 pounds.
    • Manual dexterity to operate office equipment i.e. computers, phones, etc.

     

     


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  • 11/02/15--09:11: Sr.QA Engineer (15-116)
  • The Position:

    The Sarepta Quality Assurance Unit is seeking to fill a Full-Time position for a Quality Engineer for QA Compliance to assume responsibilities associated with providing general Quality and Compliance oversight to Sarepta Therapeutics Operations in support of GMP  both internal and external operations.

    • Provide QA support and guidance to internal and external customers and support teams related to current regulations and industry best practices for maintaining quality compliance.
    • Investigation activities (Deviations, Laboratory Investigations, Corrective and Preventive Action activities, Change Control activities)
      • Work with cross functional teams during development and pilot scale batch production, scale-up/transfer trial at new or existing CMOs.
      • Generation and reporting of Quality Metrics (APRs), drafting, review and approval of Controlled Documents,
      • May assist with compliance audits as and interface with regulatory agencies as required.
      • Support the improvement and maintenance of quality systems
      • Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
      • Participates in developing Standard Operating Procedures to ensure quality objectives are met.
      • Interfaces with contract manufacturers as well as internal departments to address compliance issues.
        • Demonstrates strong proficiency in application of QA Systems principles, concepts, industry practices and standards.

    The successful candidate will have experience with general Quality Management Systems in a regulated environment, ability to collaborate with small teams to meet program deliverables, job history with a focus on Quality Assurance Compliance, and will be expected to interact with many groups of different levels across Sarepta. Knowledge of risk assessment processes, root cause analysis and change control is also preferred.

    This appointee will be responsible for working closely with the Sr. Manager of QA Compliance and Departmental staff in support of the ongoing maintenance and continuing improvement of Sarepta’s QMS.   

    This position reports to the Sr. Manager QA Compliance.

    Education and Skills Requirements: 

    • Bachelor’s Degree required; Bachelor’s Degree or higher in a scientific discipline preferred
    • Minimum 5+ years’ experience in a regulated industry required; in a Quality Assurance Compliance role preferred
    • Other requirements include:  Excellent organizational skills; ability to work independently and in team environments; understanding of FDA/EU GMP Quality Requirements; familiarity with FDA current Good Manufacturing Practices
    • Must have technical knowledge of API, finished Pharmaceuticals/Biologics manufacturing and laboratory operations.
    • Proficiency in Microsoft Word, including editing, formatting, utilizing templates, creating forms and embedding hyperlinks, and basic experience and competency with Excel and Adobe Acrobat Professional is required
    • Travel required

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    First Light Biosciences is developing breakthrough automated medical diagnostic products for rapid, sensitive, automated, and cost-effective detection of the microbes that cause hospital infections. The products address the key medical need to rapidly determine the right antibiotic to cure these life-threatening infections. Based on its proprietary MultiPath™ digital imaging technology, First Light’s products will combine the performance of the most advanced automated commercial laboratory tests with unprecedented affordability and ease-of-use.

    First Light Biosciences is a well-funded Bedford, MA company offering a stimulating environment with a culture of excellence in science, engineering, and business.

    The Systems Engineer will lead our efforts in maintaining our Design History Files created while implementing First Light’s powerful new technology.

    Responsibilities:

    • Drive the technical requirements process for our MultiPath System from feasibility through commercialization.
    • Drive the design verification process to be sure that the produced product meets the requirements as specified including experimental design and analysis.
    • Perform trace matrix analysis
    • Maintain and perform the risk analysis process
    • Implement FMEAs as required

    Qualifications:

    • BS in Electrical Engineering or related engineering discipline.
    • At least 10 years’ experience developing automated medical diagnostic platforms.
    • Demonstrated success leading the systems efforts in electromechanical medical diagnostic development.
    • Significant experience with GDP systems with a focus on design history files.
    • Excellent communication skills.

    Position type: Full-time

    Competitive salary and benefits. Title and compensation depend on experience and education

    Please apply by email only to jobs@firstlightbio.com. To ensure proper processing include the Job Code SENOV15MBC in the subject line of the email.


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  • 11/02/15--09:15: Clinical Research Associate
  • Clinical Research 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.  Upon receiving regulatory clearance, we intend to commercialize T2Dx and T2 Candida and our goal is to launch these product candidates commercially in the United States in the first half of 2015.

    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.

    Summary:

    We are seeking a talented and highly motivated individual to join our team as a Clinical Research Associate. This position will report directly to the Vice President, Clinical, Regulatory and Quality Assurance.

    Responsibilities:

    Responsible for site management in the conduct of clinical trials, inclusive of the following:

    • Assists in the design of study protocol, case report forms, informed consent for sound and thorough data to support the device through the approval process.
    • Acts as the key liaison between the company, clinical investigators and study site personnel.
    • Initiates, monitors and conducts Study Close Out procedures at clinical study centers; inclusive of training of study site personnel, oversight of protocol adherence, data verification of source documents and accountability of all study supplies.  Must be able to troubleshoot and resolve routine study conduct issues. 
    • Prepares project status and study reports.
    • Provides prompt reporting and follow through of regulatory deviations and adverse event reporting.
    • Assures compliance of clinical studies with Good Clinical Practice (GCP), Federal regulatory requirements, and T2Biosystems’ Standard Operating Procedures (SOPs).  Timely reporting and follow up of compliance deviations.
    • Responsible for the management of all clinical study supplies.
    • Responsible for the preparation and maintenance of study master files.
    • Responsible for study enrollment tracking and reporting at individual study centers.
    • Coordinates all data entry activities with data management team including data clarification processing, review, and verification of investigator clarification responses.
    • Works with clinical sites and data management team to facilitate resolution of all data management queries.
    • Interfaces with clinical, regulatory, sales, marketing and administrative staff.

     

    Skills and Experience:

    • BS degree in in biology, physical sciences, nursing or other related field. 
    • Minimum of five years experience with clinical trials, either in industry or academic setting.
    • Knowledge of FDA guidelines and regulations governing conduct of clinical trials.
    • Interpersonal and communication skills necessary to interact with study site personnel and physicians.
    • Ability to travel approximately 30%-40% of time.
    • Strong organizational skills and ability to handle multiple priorities in a fast-paced environment.
    • Must have excellent computer skills including Microsoft Office, Word, Power Point, Excel, Access, and clinical database management software.

    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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  • 11/02/15--09:15: Bioinformatics Scientist
  • Placement Type: Contractor

    Position Summary:
    We are searching for a bioinformatics scientist to join the Oncology Molecular Genomics group part of the Oncology Drug Discovery Unit at Takeda.
    Individual will be joining a team responsible for testing, integrating and analyzing proprietary and public Next Generation Sequencing data while providing a more comprehensive pre-clinical understanding of target, indication and pathway modulation for Takeda’s first in class Oncology programs.

    Duties & Responsibilities:
    The candidate will assist in maintaining our genomic computational infrastructure system and will be responsible to evaluate, communicate and implement new computational methods or feature improvements.

    The candidate will evaluate data quality, consolidate and interpret data resulting from genomic scale data analysis on Next Generation Sequencing platforms including; Exome, RNA-SEQ, miRNA, Copy Number and Epigenetic modification.

    The candidate will work collaboratively with scientists and the Information Technology group to participate in data base design, modification and maintenance to house meta data summarization and experimental analysis results.

    The position requires open and efficient interactions and communications with team members, biologists, biostatisticians, information technologists and outsource partners in a cross functional matrix environment.

    Qualifications:
    MS or PhD in a computational, statistic or bio-informatics fields and 3- 5 years experience in a computational, genomic or molecular biology related field.
    Hands on experience with Next Generation Sequencing analysis is required.
    Candidate experience with Array Studio (Omicsoft), Metacore, genome scale analysis utilizing a UNIX grid environment and possessing programs and database skills; SQL, Perl, Python, C++ and R would be desired.
    The candidate will demonstrate strong organizational and interpersonal skills with proven ability to work well in a matrix team setting. Excellent oral and written communication skills are a must.


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    Biogen is seeking a motivated scientist with knowledge and expertise in mouse biology, pronuclear and blastocyst injection to join us and contribute to development and characterization of genetically engineered models (GEMs). The candidate will reside within the GEM Center of Biogen and interact with multidisciplinary project teams in Immunology, Neurobiology, and Hemophilia to support these teams with generation of a variety of GEMs.

    Primary responsibilities will include management of the supporting colonies, hormone regimen, microinjection and surgical transfers of the embryos. Secondary responsibilities may include culture and manipulation of mouse embryonic stem cells, preparing DNA or CRISPR/Cas reagents for injection and colony management. The candidate will also contribute to R&D initiatives aimed at technical advancement of genetic engineering from the GEM Center

     

    Qualifications

    • Thorough understanding of mouse biology, molecular and genetic aspects of genetically engineered models
    • Planning and execution of GEM development by pronuclear and blastocyst injection
    • Knowledge with rodent embryology work, including divergent mouse strains, rederivation, cryopreservation and cryo-recovery, will be given special consideration
    • Familiar with culturing of mouse embryonic stem cells and conventional gene targeting
    • Excellent written and oral communication skills
    • Proven ability to work independently as well as in a team environment
    • Attention to detail, good record keeping, and great trouble shooting ability will be essential for successful performance
    • Knowledge of health monitoring, biosecurity, quarantine programs and disaster planning/recovery
    • Application of standard software including experimental data management databases
    • Compliance with IACUC protocols and AAALAC international standards
    • Knowledge in neurobiology, immunology, tissue injury and fibrosis or hemophilia is desirable

     

    Education

    • Candidates should have earned a bachelor’s degree or higher in biology or a related field with at least 2 to 5 years of post-graduate experience in the area of rodent GEM development and breeding.

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    About OpenBiome:

    OpenBiome is a nonprofit healthcare startup expanding clinical access to Fecal Microbiota Transplantation (FMT), a highly effective therapy for C. difficile, the nation’s most common hospital-acquired infection. We are currently partnering with over 350 hospitals in 49 states to treat C. difficile patients while leading new research efforts in this emerging field.

     Position Overview:

    The Laboratory Operations Trainee position is a paid two-month contracted role during which you will learn how to process samples into treatments for fecal microbiota transplants (FMT) and gain an understanding for how to become an integral member of the Laboratory Operations team at OpenBiome. Your responsibilities as a Laboratory Operations Trainee will include: 

    Processing Responsibilities

    • Handling, logging, and processing stool samples within a biosafety cabinet
    • Managing and organizing sample inventory
    • Inventorying, forecasting, and ordering lab supplies
    • Preparing buffer solution for use in sample processing
    • Labeling, organizing, and preparing samples that have been processed for shipping
    • Processing and packaging daily shipments to hospitals
    • Cleaning and sterilizing the lab before and after processing and on regular basic

     Project Coordination Responsibilities

    • Overseeing and being accountable for whole processes within Laboratory Operations
    • Performing ad hoc tasks requiring coordination between Lab Ops and other functions

    As a Laboratory Operations Trainee, your time will predominantly be allocated to Processing (90%) with some time allocated to Project Coordination (10%). 

    Since OpenBiome typically operates its laboratory seven days a week, this role requires weekend staffing. Staffing is managed by the Laboratory Operations Manager, who will assign shifts (e.g., 7:00a-12:00p, 12:00p-7:00p, etc.). As part of staffing, you will be assigned a Saturday or Sunday shift, for which you will have a different day of the week off, to provide for five total working days.

     Qualifications:

    • Laboratory experience is not required as we offer a rigorous on-the-job training and certification program; however laboratory experience in either an educational or professional setting is preferred
    • Detail-oriented and open to feedback
    • Responsible and reliable
    • Able to commute to 196 Boston Avenue in Medford, MA
    • Passion, humility, and excitement for doing whatever it takes to meet a great public health need

    Start Date and Position Progression:

    This position is open to start immediately. 

    At the end of the two-month contract, trainees will be considered for a full-time role with benefits. Based on performance and formal review, we may extend one of the following positions at OpenBiome:

    • Laboratory Technician: 90% processing responsibilities and 10% project coordination responsibilities
    • Laboratory Associate: 50% processing responsibilities and 50% project coordination responsibilities

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  • 11/01/15--22:45: Sr. QA Specialist (15-117)
  • The Position:

    The Sarepta Therapeutics Quality Unit is seeking to fill a full-time position of Sr. Quality Assurance Specilalist to assume responsibilities associated with eQMS Application Support and/or Design supporting the Quality Operations providing technical oversight to Sarepta Therapeutics Operations in support of GMP systems operations.

    Primary responsibilities include:

    • Authoring and reviewing IQ, OQ, and PQ documents including ISD (Installation support document), IQSW (Installation Qualification of software and hardware components) and various change control documentation for validated systems
    • Develop and execute Installation & Configuration of Document Content Servers, or Document Webtop clients, or Document system Admin
    • Perform Requirement Analysis, Functional Studies and Quality Reviews
    • Project management of system deployment
    • Configure modules within EtQ Reliance by consulting with process owners
    • Validate configured modules within EtQ Reliance prior to implementation
    • Enhance and troubleshoot existing modules within the eQMS platform
    • Partner with IT department as well as external vendor technical support to ensure continued positive performance of system.

    Education and Skills Requirements: 

    • Bachelor’s Degree required in a scientific discipline required.
    • Minimum 5 years in the Pharmaceutical or Medical Device industry.
    • Knowledgeable in quality systems and quality processes
    • Project management skills, team collaboration, detail-oriented
    • Experience with eQMS applications such as, EtQ Reliance 
    • Experience with enterprise application software used within life science companies
    • Experience using development and support tools
    • Other requirements include:  Excellent  organizational skills; ability to work independently and in team environments; understanding of FDA GMP Quality Requirements; familiarity with FDA current Good Manufacturing Practices and Good Documentation Practices; and experience training personnel on Quality Management and Quality Assurance concepts

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  • 11/01/15--22:50: Senior Scientist
  • Senior Scientist

    This is an opportunity for a ADME scientist with 4-6 years of experience in the pharmaceutical/CRO industry to assist in running and managing ADME assays at a fast-paced international company, the world leader in ADMET innovation.

    Cyprotex US, LLC is seeking a hands-on, highly motivated scientist to apply fundamental cell biology, biochemistry, and analytical techniques to conduct routine ADME assays. The successful candidate will actively participate in experimental design, performing experiments, and troubleshooting, as well as performing data analysis, interpretation, and report writing. The ideal candidate will be independent, self-motivated, collaborative, organized, and able to multitask effectively.  You will work in a collaborative, international team environment with other colleagues at Cyprotex US, LLC (US) and Cyprotex (UK).

    Requirements

    ▪   Experience working in drug discovery programs in pharmaceutical companies or CROs

    ▪   Have performed routine in vitro ADME assays and/or bioanalysis.

    ▪   Excellent written and verbal communication skills.

    ▪   The ability to work independently.

     

    Basic Qualifications

    ▪   Results-oriented MS/Ph.D.-level scientist with ands-on experience in designing/conducting ADME/DMPK assays

    ▪   A minimum of 4 years of pharmaceutical/CRO industry experience

    Preferred Qualifications

    ▪   Working experience in testing compounds in cell based or biochemical assays

    ▪   Experience in handling LC/MS/MS instrumentation and knowledge of small molecules/peptide LC-MS/MS methods development

    ▪   Experience with laboratory automation equipment is a plus

     

    Principals only. Relocation assistance not provided.

    To apply, email your résumé to US-careers@cyprotex.com


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  • 11/01/15--22:52: Sr. QA Manager (15-118)
  • The Position:

    The Sarepta Quality Assurance Unit is seeking to fill a Full-Time position of Quality Assurance Manager to assume responsibilities associated with managing the process for Batch Approval, Lot Release and Product Disposition in support of a GMP Quality Management System. 

    The position will encompass various tasks including but not limited to the following:

    • Working hand in hand with Contract Manufacturing Organizations (CMO) and Contract Testing Laboratories regarding review of Batch Records and Testing Data
    • Developing, implementing and improving a quality system for Lot Release and Disposition of Critical Raw Materials, Drug Substance and Drug Products intended for use in Clinical Trials, as well as commercial use
    • Implementing a standard, metric based release program that facilitates lot release planning
    • Additional responsibilities will include assisting in Investigation activities, Corrective and Preventive Action activities, Change Control activities and providing general quality assurance support for the overall Quality System in place at Sarepta

    The successful candidate will have experience with general Quality Management Systems in a regulated environment, personnel management of small teams, job history with a focus on Lot Release and Product Disposition, and will be expected to interact with many groups across Sarepta, at all levels within the organization.

    This appointee will be responsible for working closely with Sarepta Management and Departmental staff in support of the Quality Management System.   

    Primary responsibilities will include the following:

    • Tracking and reporting release metrics
    • Work with various user groups to facilitate Lot Release workflow processes
    • Providing general quality assurance support for the overall Quality System in place at Sarepta and at Sarepta’s CMOs and CTLs

    Education and Skills Requirements: 

    • Bachelor’s Degree required; Bachelor’s Degree or higher in a scientific discipline preferred
    • Minimum 7+ years’ experience in a regulated industry required; in a Quality Assurance Lot Release role preferred
    • Other requirements include:  Excellent organizational skills; ability to work independently and in team environments; understanding of FDA GMP/GCP/GLP Quality Requirements; familiarity with FDA current Good Manufacturing Practices and Good Documentation Practices; and experience training personnel on document control systems and Quality Assurance concepts
    • Proficiency in Microsoft Word, including editing, formatting, utilizing templates, creating forms and embedding hyperlinks, and basic experience and competency with Excel and Adobe Acrobat Professional is required
    • Experience in working within document control systems is preferred
    • Experience with Electronic Document and Quality Management Systems preferred

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  • 11/01/15--23:41: Manager Strategic Planning
  •  

     Job Description:

    The Strategic Planning Manager will lead OvaScience’s strategic planning process cross-functionally to help support decision-making and resource planning. The role will also support business strategy projects through problem definition and structuring, fact gathering and analysis, synthesis of findings into compelling recommendations, stakeholder alignment, presentation to leadership, execution and tracking of progress. The position will not have any direct management responsibility in the near-term, though will involve working with and influencing a broad range of internal stakeholders.  The position reports to the Associate Director, Strategic Planning.

    Essential Functions:

    • Work cross-functionally to develop and manage integrated corporate strategic plan, highlighting key milestones and risks for management
    • Develop metrics / dashboards and other reporting tools to drive decision making
    • Track progress of corporate strategic plan and provide regular updates to management
    • Support the overall process of corporate strategic decision-making to ensure the organization maximizes its short and long-term goals by developing appropriate analytics, metrics, and tools

    Education:

    • BA/BS +5 years or MBA + 3 years strategy consulting experience in a management consulting firm and/or corporate strategic planning experience.
    • Relevant experience in pharma/biotech is a plus but not required.

    Knowledge, Skills and Abilities

    • Ability to build strong relationships with cross-functional teams
    • Excellent interpersonal skills including communication and influencing skills
    • Results oriented with excellent decision making and facilitation skills
    • Expertise in project management
    • Strong analytical and quantitative skills
    • Experience developing metrics to measure success against goals
    • Self-starter and resourceful
    • High degree of flexibility exhibited in a “can do” attitude
    • Excellent Microsoft Excel and Power Point skills to drive analysis and decision-making  

     

     

     

     

     

     


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  • 11/01/15--23:52: Administrative Assistant
  • Aphios®, an emerging-growth biotechnology company, is developing enabling technology platforms and enhanced therapeutics for health maintenance and the prevention and treatment of cancer and supportive care, infectious diseases such as HIV and CNS disorders such as Alzheimer’s disease.  We are seeking a qualified individual to fill the following position:

    Job Title:  Administrative Assistant

    Job Code:  APH-1511-01

    Job Category:  Administrative

    ADMINISTRATIVE ASSISTANT -- Aphios Corporation is seeking an energetic and qualified individual to assist with daily administrative duties and marketing tasks.  Administrative duties include, but not limited to, answering phones, greeting clients, filing, copying, document organization, written communications and updating websites. Marketing tasks include, but not limited to, establishing and coordinating conference calls and meetings with strategic corporate partners and investors as well as social media and Internet marketing. 

    Candidate must be an organized professional and a self-starter with excellent written and oral communication skills.  Candidate must have the ability to multi task and be proficient in Microsoft Office.  Knowledge of HTML, Joomla, Salesforce and social media a plus.  Candidates must have a Bachelor degree in business administration or marketing and 2-5 years of work related experience.  Excellent opportunity to apply your skills in a dynamic life science environment and learn new skills in a health related industry.  

    Send resume with cover letter to careers@aphios.com with job code in the subject line.

    Dr. Trevor P. Castor

    Aphios Corporation

    3-E Gill Street, Woburn, MA 01801

    Web Sites:  www.aphios.comwww.aphioshwc.com 

    E-mail:  careers@aphios.com

     

    No telephone calls please                                        An equal opportunity employer


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