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Career postings for the Massachusetts Biotechnology Council

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    Codiak Biosciences is leveraging recent advances in the biology of extracellular vesicles and their role in intercellular communication.  Codiak aims to become the world’s leading company in developing exosomes as a new therapeutic and diagnostic modality for the treatment of a wide array of diseases, including cancer. Recent discoveries have demonstrated that exosomes derived from normal cells can act as a potent and safe delivery system for multiple therapeutic payloads. These small vesicles, which leave cells and travel throughout the body, can mediate dramatic effects in animal models of disease.  The group has also shown that exosomes derived from cancer cells contain specific proteins on their surface that can be used to quickly detect and characterize cancer from a sample of patient’s blood. They can also be used to monitor the response to cancer treatment, and to detect relapses.

     

    Codiak Biosciences is seeking a creative and accomplished exosome/extracellular vesicle biologist with a demonstrated record of exosome production, isolation, and characterization.  The position is for a bench scientist who can design and execute studies that address fundamental questions of exosome biology while helping to scale early exosome production for pre-clinical and early clinical studies.

    Success in this role will rely heavily on flow cytometry, ELISA, and protein engineering, but an ability to pick up diverse characterization tools and methods will be necessary as research progresses.  Cell culture experience is a plus.

    This is a unique opportunity for a strong scientist to contribute experimentally, as well as intellectually, to both a drug discovery and a diagnostic development research program.  As part of a start-up the candidate will be uniquely exposed to the full range of company activities within and outside the lab. The candidate will also play a critical role in helping shape Codiak’s scientific and business direction.

    Qualifications

    • PhD in biology, biochemistry, drug discovery, or a related subset thereof. Post-doc experience is appreciated, but not necessary. 
    • Should be a motivated biologist with a background in oncology, immunology or cell biology.
    • Development experience with cell and biochemical assays.
    • The ability to work well independently, and as part of the growing Codiak team, and be able to quickly design and execute thoughtful experiments. 
    • An aptitude for efficient and dynamic experimental design is critical in early development and the need to prioritize, and then re-prioritize, diverse studies is invaluable.

    Additional qualifications include, but are not limited to;

    • Exosome isolation and characterization
    • Primary cell and ex-vivo analysis of cells and tissues
    • Flow cytometry and ELISA assays
    • Vector construction and transduction
    • Experience with design and execution of mouse trials
    • Experienced in protein, DNA and RNA methods including western blot analysis, recombinant DNA technology, and RT-PCR
    • Diagnostic development and validation experience is a plus

     

    Those interested in contributing to Codiak Biosciences’ development of the nascent and exciting field of exosome biology may email their CV and any relevant credentials to Careers@codiakbio.com.


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    Charles River Laboratories 

    The drug research and development process is highly complex, lengthy and expensive, yet essential for delivering safe and effective therapies to patients.

    To help our clients navigate this process, Charles River Laboratories offers a wide range of products and services that span the entire drug discovery and development continuum and can be tailored to specific research conditions.

    Specialties: Research Models & Services, Preclinical Services, Discovery Research Services, Biologics Testing Solutions, Endotoxin Detection & Microbial Identification

    WE ARE SEEKING TO ADD TO OUR TEAM:   Associate Director, Regulatory Compliance

     

    Responsibilities

    BASIC SUMMARY:

    Responsible for managing the Good Laboratory Practice (GLP) Quality Assurance program at a Charles River Laboratories Preclinical site. Work with site, divisional and corporate management to ensure consistency with meeting business objectives and for ensuring compliance with all federal and state regulations. Responsible for assuring compliance with all appropriate GLP regulations, Charles River corporate policies, USDA and DEA regulations. Provide regulatory direction in the development and implementation of the site Quality System programs.

     

    ESSENTIAL DUTIES AND RESPONSIBILITIES:•Communicate all identified compliance and quality risks related to U.S. Preclinical Services operations to the Corporate Vice President, Regulatory Affairs and Compliance. •Manage direct reports at sites; ensure that Quality Assurance Unit (QAU) responsibilities are fulfilled as defined in 21 CFR Part 58 GLP regulations; develop and review departmental policies and procedures to support GLP requirements. •Update and maintain required QA audit programs (internal and external) and related documentation •Manage the development, implementation and maintenance of Quality Assurance programs and activities in a regulated environment to ensure compliance with federal/state regulations. •Ensure that objectives of the Quality programs are defined and communicated across site operational groups. •Maintain a close working relationship with Charles River’s management (direct and indirect reporting relationships) to ensure a unified approach to managing Quality programs. •Provide guidance to operational management in preparation for regulatory inspections. •Serve as key company representative during agency inspections (FDA, EPA, USDA etc.); interface and host inspections; develop positive working relationships and ensure that compliance objectives are met. •Develop and/or review all site-specific responses to regulatory agency and client QA inspections and corrective action commitments in collaboration with corporate quality; ensure timely responses are generated. •Apprise management of the status of commitments to the regulatory agency. •Ensure that corporate Quality policies are implemented and administered consistently across sites. •Ensure that appropriate training is provided to staff as well as GLP training to all facility personnel. oParticipate in the development and planning of agency/client inspection readiness training, conduct focused GLP training as necessary. •Ensure that all client qualification inspection reports are responded to in a timely manner. •Manage Quality Assurance, archive and document control functions at designated site. •Ensure Quality Assurance oversight and involvement in computer validation projects. •Establish and maintain a periodic review system to assure compliance with standard operating procedures and GLP. •Ensure QA review of programs and procedures in support of USDA/IACUC compliance. •Direct and administer programs for measuring compliance by establishing metrics on critical quality endpoints and provide periodic reports to management with recommendations for continuous quality improvements. •Participate and contribute to all projects having a quality impact across sites (e.g. facility projects, Preclinical Services regulatory initiatives, Corporate Quality audit programs, etc.). •Participate in Global Quality meetings, QA web page updates, corporate QA/RA policy development and relevant QA/RA strategic planning sessions. •Direct activities of assigned group(s) to ensure effective performance of function. •Assist other company divisions on related quality issues. •Develop and maintain Quality Assurance consulting projects. •Performs all other related duties as assigned.   MANAGEMENT RESPONSIBILITIES:•Interview and select qualified exempt-level departmental personnel. Recommend, review and approve personnel actions, including hiring, promotions and raises. Partner with Human Resources in the handling of disciplinary issues. Prepare and/or approve appropriate personnel action paperwork. •Ensure that management training and development needs are identified and programs initiated. Direct the development of departmental orientation and other training programs. •Monitor performance of direct reports. Provide regular coaching and counseling. Prepare and deliver salary and performance reviews; review and approve performance and salary appraisals initiated by direct reports. •Monitor and determine appropriate levels of departmental overtime. Review and approve vacation/time off requests for direct reports. •Develop short- and long-range operating objectives, organizational structure, and staffing requirements. Oversee the development of a departmental plan for backup and succession of key departmental personnel. •Develop and recommend departmental budget. Authorize expenditures in accordance with budget. Approve budget and expenses of subordinates. •Ensure optimum performance of group function. Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices. •Direct the development and communication of departmental systems, SOPs, policies and procedures. Partner with Human Resources to develop and approve departmental job descriptions; ensure communication of duties and responsibilities to employees. •Support and affirm the Company’s policies of equal opportunity through Affirmative Action. •Perform all other related duties as assigned. 

    Qualifications 

    •Education: Bachelor’s degree (B.A. /B.S.) or equivalent in a scientific discipline or related field.   •Experience: Seven to ten years related experience in a Biotechnology based industry with a minimum of five years of direct responsibility for Quality Assurance/Regulatory Affairs. •An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.   •Certification/Licensure: None.   •Other: Demonstrated leadership skills required. Working knowledge of GLP regulations or regulatory affairs pertaining to the pharmaceutical and biotechnology industries required. 

    Equal Employment Opportunity

    Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet

     


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    Codiak Biosciences is leveraging recent advances in the biology of extracellular vesicles and their role in intercellular communication.  Codiak aims to become the world’s leading company in developing exosomes as a new therapeutic and diagnostic modality for the treatment of a wide array of diseases, including cancer. Recent discoveries have demonstrated that exosomes derived from normal cells can act as a potent and safe delivery system for multiple therapeutic payloads. These small vesicles, which leave cells and travel throughout the body, can mediate dramatic effects in animal models of disease.  The group has also shown that exosomes derived from cancer cells contain specific proteins on their surface that can be used to quickly detect and characterize cancer from a sample of patient’s blood. They can also be used to monitor the response to cancer treatment, and to detect relapses.

     

    Codiak Biosciences is seeking a protein engineer to help optimize the company’s core technology platform.  Responsibilities will include providing scientific expertise and leadership in the field of antibody and protein engineering, expression, and purification. 

    Success in this position will rely heavily on vector design, protein expression optimization, and characterization, as well as a willingness to develop a strong understanding of related biochemistry, particularly as it pertains to exosome biology.  Cell culture experience is a plus.

    This is a unique opportunity for a strong scientist to contribute experimentally, as well as intellectually, to both a drug discovery and a diagnostic development research program.  As part of a start-up the candidate will be uniquely exposed to the full range of company activities within and outside the lab. The candidate will also play a critical role in helping shape Codiak’s scientific and business direction.

    Qualifications

    • PhD in biology, protein/chemical engineering, tissue engineering, or a related subset thereof.  
    • Should be an experienced engineer with a background in immunology or cell biology.
    • Experience with diverse protein assay development is required, and having conducted past imaging studies is valuable, but not necessary.   
    • The successful candidate will have the ability to work well independently, and as part of the growing Codiak team, and be able to quickly design and execute thoughtful experiments. 
    • An aptitude for efficient and dynamic experimental design is critical in early development and the need to prioritize, and then re-prioritize, diverse studies is invaluable.

    Additional qualifications include, but are not limited to;

    • Exosome isolation and characterization
    • Cloning and protein fusion engineering
    • Electroporation, flow cytometry, and ELISA assays
    • Biodistribution and in vivo imaging studies
    • Experience with design and execution of mouse trials
    • Experienced in protein, DNA and RNA methods including western blot analysis, recombinant DNA technology, and RT-PCR
    • Diagnostic development and validation experience is a plus

     

    Those interested in contributing to Codiak Biosciences’ development of the nascent and exciting field of exosome biology may email their CV and any relevant credentials to Careers@codiakbio.com.


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  • 12/29/15--22:37: Multimedia Designer
  • Charles River Laboratories 

    The drug research and development process is highly complex, lengthy and expensive, yet essential for delivering safe and effective therapies to patients.

    To help our clients navigate this process, Charles River Laboratories offers a wide range of products and services that span the entire drug discovery and development continuum and can be tailored to specific research conditions.

    Specialties: Research Models & Services, Preclinical Services, Discovery Research Services, Biologics Testing Solutions, Endotoxin Detection & Microbial Identification

    WE ARE SEEKING TO ADD TO OUR TEAM:   Multimedia Designer

    Responsibilities

    BASIC SUMMARY:

    Responsible for combining graphic design with animation to create electronic illustration, multimedia and video to be incorporate into advertising, marketing materials and presentations.

     

    ESSENTIAL DUTIES AND RESPONSIBILITIES:

    • Design and produce multimedia deliverables to support corporate and business unit initiatives, including but not limited to animated banners, video, web design and any other multi-media pieces.
    • Develop and refine creative concepts for marketing initiatives.
    • Advise internal customers of solutions, strategies and design directions for best use of media devices to meet their objectives.
    • Oversee the development and production of direct marketing and corporate communication materials. Ensure high-quality integrated, interactive/traditional communications against strategic business objectives.
    • Provide recommendations on overall strategic direction of the branding initiative across all communications and provide tools and templates to ensure consistency and integrity of company brand.
    • Ensure overall marketing and brand consistency across business units and throughout corporate collateral.
    • Assist in any print design as necessary.
    • Perform all other related duties as assigned.

    Qualifications 

    • Education: Bachelor’s degree (B.A. /B.S.) or equivalent in graphic arts or related field.
    • Experience: Five plus years related experience and/or training.
    • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
    • Certification/Licensure: None
    • Other: Specific training and/or experience in the visual arts. Must have experience with Multimedia Software. 

    Equal Employment Opportunity 

    Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet

     


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  • 12/29/15--22:42: RNA Scientist I
  • Codiak Biosciences is leveraging recent advances in the biology of extracellular vesicles and their role in intercellular communication.  Codiak aims to become the world’s leading company in developing exosomes as a new therapeutic and diagnostic modality for the treatment of a wide array of diseases, including cancer. Recent discoveries have demonstrated that exosomes derived from normal cells can act as a potent and safe delivery system for multiple therapeutic payloads. These small vesicles, which leave cells and travel throughout the body, can mediate dramatic effects in animal models of disease.  The group has also shown that exosomes derived from cancer cells contain specific proteins on their surface that can be used to quickly detect and characterize cancer from a sample of patient’s blood. They can also be used to monitor the response to cancer treatment, and to detect relapses.

    Codiak Biosciences is seeking an RNA engineer to help design payloads and optimize therapeutic efficacy of the company’s core technology platform.  Responsibilities will include providing scientific expertise and leadership in the field of both messenger and silencing RNA sequencing, formulation, and target delivery characterization.

    Success in this position will rely heavily on siRNA engineering, molecular mechanism characterization, and selective tissue targeting, as well as a willingness to develop a strong understanding of related biochemistry, particularly as it pertains to exosome biology.  Past experience with siRNA delivery optimization in various cancer models is a plus.

    This is a unique opportunity for a strong scientist to contribute experimentally, as well as intellectually, to both a drug discovery and a diagnostic development research program.  As part of a start-up the candidate will be uniquely exposed to the full range of company activities within, and outside, the lab. The candidate will also play a critical role in helping shape Codiak’s scientific direction.

    Qualifications

    • PhD in biology, RNA engineering, genetic sequencing, or a related subset thereof.
    • Should be an experienced molecular scientist with a strong background in immunology or oncology.
    • Experience with diverse protein assay development is required, and having conducted past RNA-specific imaging studies is valuable, but not necessary.   
    • The successful candidate will have the ability to work well independently, and as part of the growing Codiak team, and be able to quickly design and execute thoughtful experiments. 
    • An aptitude for efficient and dynamic experimental design is critical in early development and the need to prioritize, and then re-prioritize, diverse studies is invaluable.

    Additional qualifications include, but are not limited to;

    • Exosome isolation and characterization
    • RNA/DNA sequencing
    • Electroporation, flow cytometry, and ELISA assays
    • Biodistribution and in vivo imaging studies
    • Experience with design and execution of mouse trials
    • Experienced in protein, DNA and RNA characterization methods including western blot analysis, recombinant DNA technology, and RT-PCR
    • Diagnostic development and validation experience is a plus

     

    Those interested in contributing to Codiak Biosciences’ development of the nascent and exciting field of exosome biology may email their CV and any relevant credentials to Careers@codiakbio.com


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  • 12/29/15--22:44: Sr. IT Buyer
  • Charles River Laboratories 

    The drug research and development process is highly complex, lengthy and expensive, yet essential for delivering safe and effective therapies to patients.

    To help our clients navigate this process, Charles River Laboratories offers a wide range of products and services that span the entire drug discovery and development continuum and can be tailored to specific research conditions.

    Specialties: Research Models & Services, Preclinical Services, Discovery Research Services, Biologics Testing Solutions, Endotoxin Detection & Microbial Identification

    WE ARE SEEKING TO ADD TO OUR TEAM:   Sr. IT Buyer

    Responsibilities

    BASIC SUMMARY:

    Procure equipment, materials and services for assigned areas requiring specialized product knowledge or interpretation of technical requests. Contact vendor(s) to obtain equipment, supplies, and materials at the lowest competitive cost for product and services.

     

    ESSENTIAL DUTIES AND RESPONSIBILITIES:  •Obtain critical materials and components, equipment and services through interviewing and/or visit vendors to ensure supplier is qualified. •Review, interpret, and verify purchase order requests. •Verify quantity, anticipated costs and practical application of supplies/materials requested. •Research sources, solicit bids, and compare areas of quality, cost, delivery and warranty/guarantee policies. •Commit company funds to vendors and expedite orders/shipment/delivery, updating end-user as necessary. •Establish and maintain automated purchase inventory files and records. •Authorize payment to vendor and establish adjustments as required. •Partner with QA department to perform supplier audits. •Perform all other related duties as assigned.  

    Qualifications 

    •Education: Bachelor’s degree (B.A. /B.S.) or equivalent in Business Administration or related discipline.   •Experience: Four to six years related experience and/or training. •An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.   •Certification/Licensure: None   •Other: None  

    Equal Employment Opportunity 

    Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet

     


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    Our Greater Boston area client, a recognized industry leader in their delivery technology, has an urgent need for a strong Scientist who can play an integral role in protein and antibody purification for a variety of programs.  The ideal candidate will have exposure to early, late stage or even commercial experience, and for candidates who possess experience all these stages, a higher title (Senior Scientist I) is possible.  If you are a PhD with 2-8 years experience, with strong exposure to protein downstream purification, as well as process scale-up and protein chemistry, then this is the role for you.

    What We Need:

    • PhD in Biochemistry, Chemistry or Chemical Engineering with 2-8 years experience
    • Hands-on experience with process purification and analytical techniques
    • Strong communication skills, including external communication experience in working with CMOs
    • Excellent written skills, including experience with change controls and contributing to regulatory documentation
    • Commercial Process Development experience and previous management experience is preferred

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

    CHEMISTRY IS EVERYTHING™


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  • 12/29/15--22:49: Web/Copy Editor
  • Charles River Laboratories 

    The drug research and development process is highly complex, lengthy and expensive, yet essential for delivering safe and effective therapies to patients.

    To help our clients navigate this process, Charles River Laboratories offers a wide range of products and services that span the entire drug discovery and development continuum and can be tailored to specific research conditions.

    Specialties: Research Models & Services, Preclinical Services, Discovery Research Services, Biologics Testing Solutions, Endotoxin Detection & Microbial Identification

    WE ARE SEEKING TO ADD TO OUR TEAM:   Web Copy Editor

    Responsibilities

    BASIC SUMMARY:

    The Web/Copy Editor is responsible for the quality assurance and scientific integrity of the copy used on the web and in various marketing materials.

     

    ESSENTIAL DUTIES AND RESPONSIBILITIES:•Edit web content, ad copy, eblasts, technical datasheets, scientific posters, white papers, catalogs, etc., for accuracy, grammar, spelling, consistency and adherence to established style guidelines •Review and approve updates/additions made to the website by various contributors through our content management system before they go live to ensure consistency with corporate guidelines and objectives. •Create web pages for unique URLs used in targeted marketing campaigns in order to track customer response. •Monitor overall website traffic using analytic platforms to identify trends in user behavior •Monitor company’s website rankings in the major search engines for a list of top keyword phrases and use metadata and other methods to optimize pages for increased organic rankings when necessary. •Develop, communicate and enforce Internet Style Guide. •Provide ad hoc writing support as needed •Perform all other related duties as assigned.

    Qualifications 

    Education: Bachelor’s degree in English or Science preferred. •Experience: Two to four years related experience and/or training. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. HTML, CSS, JavaScript, Flash or jQuery experience a plus.   •Certification/Licensure: None   •Other: Must possess a thorough knowledge of the mechanics of writing, be proficient with word processing, be detail oriented, and have the ability to deliver work in a timely fashion to meet scheduled deadlines. Familiarity with Chicago Manual of Style a plus.

     

     

    Equal Employment Opportunity 

    Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet

     


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  • 12/29/15--23:02: HRIS Analyst
  • Responsibilities

     

    BASIC SUMMARY:

     

    Responsible for defining specifications, implementing and providing technical assistance in support of the corporate Human Resources Information System (HRIS) application system.

     

    ESSENTIAL DUTIES AND RESPONSIBILITIES: 

    •In conjunction with users and HR managers, define requirements, document specifications, implement and support the Company’s HRIS application (PeopleSoft) to meet the needs of Charles River globally.

    •Participate as team member to define, design, implement, support and test the solution through the system development life cycle.

    •Implement and plan for improvements, enhancements, and new applications to the system.

    •Identify, prioritize, escalate (as necessary) and facilitate resolution of project issues and ensures complete and quality delivery.

    •Participate, where required, in testing and validation of the application.

    •Ensure solutions are transitioned smoothly through the production cut-over process.

    •Lead training and / or ensure effective knowledge transfer to those responsible for training. Partner with other technical staff to plan, fix and implement patch releases as required and governed. Manage user expectations through timely communications.

    •May oversee the completion of projects including planning, assigning, monitoring and reviewing progress and accuracy of work; evaluating results, etc.

    •Perform all other related duties as assigned.

    Qualifications

    •Education: Bachelor’s degree (B.A./B.S.) or equivalent in computer science, engineering, business administration or related discipline.

    •Experience: Minimum of 5 years related experience in HR, with significant involvement in direct support of HR-related systems, including 5+ years experience with PeopleSoft (version 9.1 or higher) enterprise applications, including Benefits Administration,TAM / Candidate Gateway, HCM, Payroll Interface and vendor integration.

    •An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

    Certification/Licensure: None

    Other: oKnowledge of PeopleTools –Application Engine preferred. Knowledge of XML Publisher, SQR strongly preferred. oProficient in the use of Access and other MS Office tools (Excel, Word, PowerPoint). oIn-depth knowledge of current IT technologies and state-of-the-art practices, particularly in program management.

    Equal Employment Opportunity

    Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet

     




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  • 12/29/15--23:31: Quality Control Scientist
  • Our “A” level research group located in the biopharma hotbed of the nation is looking for a talented QC scientist.  If you have the ability to work effectively in a collaborative team environment, see how your expertise can have an impact using cutting edge gene therapy.  This amazing opportunity is looking for someone who also meets the following requirements:

    • BA / BS with approx. 2-5 years of industry experience in QC GMP environment with exposure to biologics programs

    • Strong working knowledge of cGMP/ICH/FDA/EU regulations

    • Experience with cell culture, qPCR, Flow Cytometry

    • History of compiling and verifying data in the CMC sections of regulatory filings

    • Experience with external vendors

    • Excellent organizational and communication skills working across many levels

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

    CHEMISTRY IS EVERYTHING™

     


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    Responsibilities

    BASIC SUMMARY:

    Direct the development, administration, and management of the company’s Global Regulatory Affairs program. Ensure the company is compliant with all applicable international, national, and state regulations and corporate policies to avoid business disruptions. Direct all regulatory agency activities including Biological License Agreements (BLA), supplements and new product application filings, as well as site registrations and licenses.

    ESSENTIAL DUTIES AND RESPONSIBILITIES:

    •Provide overall direction, administration, and management of the company’s Regulatory Affairs program.  

    •Maintain current knowledge of foreign and domestic (US) regulations as they pertain to regulated business units as well as ISO certification requirements.  

    •Responsible for all interactions with regulatory agencies including responses to regulatory inspections, regulatory submissions, responses to regulatory submissions, and meetings with regulatory agencies.  

    •Provide Regulatory Affairs expertise and guidance for all regulatory filings, submissions and correspondence across the company’s regulated international businesses.  

    •Develop Regulatory logistics, planning and guidance for product licensing and distribution.  

    •Develop, revise, maintain and organize the Global Regulatory Affairs program and communicate the status of regulatory compliance to senior management through periodic meetings and presentations.  

    •Review and implement all corporate Regulatory Affairs and Compliance policies.  

    •Ensure that all contracts between the company and its clients are properly reviewed for regulatory coherence and are amended when necessary to assure that the appropriate regulations are cited and the level of compliance is attainable by both parties.  

    •Responsible for regulatory reviews of client agreements and recommendations for revisions.  

    •Responsible for assuring the maintenance of the company’s regulatory records, regulatory agency correspondence and submissions, including inspection records, client agreements Regulatory Affairs and Compliance standard operating procedures (SOPs).  

    •Engage in Due Diligence and Post Merger Integration initiatives as assigned.  

    •Direct activities of assigned group(s) to ensure optimum performance of the group/function.  

    •Establish close working and communication relationship with QA site leads.  

    •Ensure Business Leaders are aware of regulatory status of filings, communications and projects.  

    •Establish strong communication relationships with key corporate stakeholders (legal, procurement, EHS, etc).  

    •Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.  

    •Develop short- and long-range operating goals, organizational structure, staffing requirements and succession plans.  

    •Integrate activities with those of other major organizational units (e.g. segments, departments, functions).  

    •Develop and recommend departmental budget and authorize expenditures.  

    •Develop and oversee the implementation of departmental training programs, including orientation.  

    •Support the policy of equal employment opportunity through affirmative action in personnel actions.  

    •Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].  

    •Perform all other related duties as assigned.

    Qualifications

    Education: Bachelor’s degree (B.A. /B.S.) or equivalent in a scientific or related discipline.

    Experience: Eight to ten years related experience in a Pharmaceutical/Biotechnology/Medical Device- related industry having direct responsibility for Regulatory Affairs. •An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

    Certification/Licensure: Member of Regulatory Affairs Society (RAPS)

    Other: In-depth knowledge of US 21 CFR parts 58, 210/211, and 820 and OUS related guidance documents. Excellent interpersonal and communications skills required.  

    Equal Employment Opportunity

    Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet


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  • 12/30/15--06:36: Sr Clinical Program Manager
  • Tokai Pharmaceuticals is seeking an experienced Senior Clinical Program Manager (Sr. CPM) to add to their team.  The Sr. CPM is responsible for overall management, coordination, and supervision of a large, global clinical trial to ensure timely delivery of required objectives and timelines within the scope of clinical trial agreement and project budget.  This person will be an excellent team leader with an established record of seeing tasks through to completion.  The Sr. CPM will have a wide functional area of expertise, including: 1) study planning, training, implementation, and completion; 2) selection and management of Principal Investigators; 3)  selection and management of Contract Research Organizations and other outside consultants and vendors; 4) and creation and management of project budgets.

    Essential Job Duties and Responsibilities

    • Develop clinical development operational plans and study timelines.  Take the lead role in drafting or oversight of developing clinical protocols, Investigator Brochures, Information/Consent forms, Clinical Study Reports, CRF’s, diary cards, training material, and other clinical documents, as required by the project, including clinical sections of regulatory submissions.
    • Arrange and manage resources to conduct clinical trials, including Contract Research Organization and Consultants.  This will involve assisting the Director of Clinical Operations with identifying and selecting resource providers and evaluating these services on an ongoing basis.
    • Coordinate with other functional areas (e.g., Regulatory Affairs, Medical).
    • Negotiate and develop contracts and budgets to ensure required services are contracted as cost-efficiently as possible and ensuring appropriate internal review, as applicable.
    • Manage budgets and timelines. Make sure that all tasks are completed that contribute to the conduct of a clinical study, ensure that they are within budget and appraise the Head of Clinical Operations & Program Management of progress and situations as they arise.
    • Provide guidance on the resolution of issues as they arise in consideration of applicable regulatory guidelines and appropriate Quality Systems.
    • Wide functional area of expertise including primary Sponsor review of Statistical Analysis Plans, Data Management Validation Plans, Data Handling Reports, Clinical Study Report Appendices including Statistical Output, Tables and Listings
    • Chair meetings of internal and external teams to ensure smooth running of clinical programs.
    • Provide support for Clinical Operations, as required.   This could include writing and reviewing department and company SOPs, maintain files, contribute to regulatory filings, etc.
    • Other duties, as assigned.
    • Provide innovative solutions to situations as they arise and contribute ideas to improve department functioning and the future development of clinical programs.

    Experience Requirements

    • BA/BSc degree required, advanced degree optional (e.g., MSc, MPH, PhD). More than 5 years industry experience in clinical research management (CTM-III or equivalent), including global clinical trials.  Experience in oncology highly preferred.
    • Training and experience in applicable regulatory guidelines, including but not limited to: Good Clinical Practices, Good Manufacturing Practice, Code of Federal Regulations.
    • A good scientific background for understanding technical and regulatory issues relating to the development of vaccines is required.
    • Excellent team player with good interpersonal, coordination, organization, and communication skills.
    • Ability to problem solve by seeking guidance while presenting solutions

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     Anika Therapeutics is a global medical technology company at the forefront of pain management, tissue regeneration and wound healing. We are committed to delivering innovative medical solutions that help patients feel better faster, look and feel younger and remain active. With over 7 million procedures performed over the past twenty years utilizing our proprietary technology, Anika is helping individuals all over the world return to life naturally.

    Anika Therapeutics currently has an opening for a Product Development Scientist. The position will collaborate with internal and external stakeholders and vendors to plan, execute and advance product development initiatives pertaining to the use of established products and new product candidates in orthopedics. This will include technology searches, laboratory testing, verification and validation, and animal testing.

    The Company offers and competitive compensation and benefits package including medical, dental, life and disability insurance, and 401(k) retirement planning.

    Additional information on benefit offerings and a complete position description can be found on the Careers page of the website at www.anikatherapeutics.com.


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    GENERAL SUMMARY OF POSITION:

    Under the direction of the Director or designee, the Project Coordinator I provides analysis and support for projects, administrative, and general operations. Responsible for independent action on multiple projects as assigned. Tasks vary according to the priorities of the department.

    In addition to job responsibilities, the following elements will be required:

    • Maintaining national and/or international working group and/or consortia lists and communications between the difference centers and individuals involved. This will require complex task of communications with different level participants (funding institution, physicians, leadership goups, nurses, etc) .
    • Within UMMS the project coordinator ail be responsible to assist the Director of the newly established Liver Institute in establishing membership, procedures, maintaining communication, meeting and seminar planning and communication with outside agencies.
    • Conference organization, travel to regional, national or international meetings may be involved.
    • Availability beyond the regular work hours by email/phone is expected on the per needed basis.
    • The professional position will require flexibility in the work hours to provide timely completion of tasks.
    • Minimum of 1 year direct experience preparing manuscripts and grants.

    THIS IS A 32 HOUR PER WEEK POSITION

    MAJOR RESPONSIBILITIES:

    • Organize and plan work activities of the Department for review with appropriate senior staff
    • Implement and manage tasks in accordance with departmental objectives
    • Participate as a member of project teams
    • Assist senior staff with project development activities: compiling data, drafting reports, and assisting with special projects
    • Maintain project plans in Microsoft Project and produce related project reports
    • Compile and analyze data, and draft project reports for review by senior staff
    • Initiate and maintain contact with key personnel including staff, department heads and external parties
    • Update the Director or designee on project details and changes in a timely manner
    • Review pertinent correspondence, communications and other background materials on a daily basis to remain current on project and operation details
    • Draft routine correspondence, meeting minutes, management reports for the Director or designee and department staff
    • Prepare multi-media presentations and reports utilizing a variety of software applications including, but not limited to: Microsoft Word, PowerPoint, and Visio
    • Develop and maintain time schedules for department staff, project events and office activities
    • Maintain project files and support materials
    • Perform other duties as required

    REQUIRED QUALIFICATIONS:

    • Bachelor's degree in business administration, a related field, or equivalent experience

    • 1 year of experience coordinating and planning projects

    • Ability to work in a team and meet performance deadlines in a dynamic environment
    • Excellent oral and written communication skills necessary to interact with clients and staff
    • Demonstrated experience in using computer-based tools including electronic mail, word processing, spreadsheet and database products.



    Apply Here

    PI92620514


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  • 01/01/16--02:30: Business Development Manager
  • ABOUT KINIKSA

    Kiniksa Pharmaceuticals is a privately held biotechnology company focused on developing and delivering therapeutics to patients with devastating diseases and unmet medical needs. The company has an experienced management team with demonstrated history of success, significant funding and a clear vision of building a global, generational company. The company is assembling a pipeline through innovative transactions and is actively looking to acquire or in-license additional programs and technologies across all stages of development.

    POSITION SUMMARY

    The candidate will aid in:

    (1) the commercial and scientific assessment of in-licensing and M&A opportunities;

    (2) conducting primary and deep-dive secondary market research to support in-licensing and M&A opportunities and in-line programs;

    (3) building complex models to support deal negotiations and internal strategic planning initiatives; and

    (4) supporting deal negotiations.  

    EDUCATION, SKILLS AND ABILITIES

    - Deep passion for bringing therapies to patients with devastating diseases

    - BS/BA in a life-science or highly quantitative discipline required (e.g., biochemistry, biophysics, engineering, chemistry), graduate degree highly preferred

    - Ideal candidate will have at least 1-2 years of experience in strategy consulting, private/public equity investment, investment banking or corporate development 

    - Broad-based scientific knowledge across human health therapeutic areas

    - Superior Excel and PowerPoint skills (knowledge of VBA a plus)

    - Experience with or ability to build complex quantitative models (including, but not limited to, risk-adjusted cash flow statements, Monte Carlo simulations, decision trees for real options analysis, etc)

    - Insatiable curiosity and willingness to learn

    - Tireless work ethic

    - Strong teamwork, networking, organizational, administrative and analytical skills, along with sound judgment

    - Ability to adapt to changes in plans/projects/priorities on short notice


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  • 01/01/16--04:35: Project Administrator
  • Project Administrator, German Accelerator Life Sciences, Boston/Cambridge

    German Accelerator Life Sciences (GALS) is a new initiative that helps German life science startups and young companies to succeed in the global market. Support provided by GALS ranges from free office space in the world's most dynamic life science innovation hub to mentoring and consulting by industry experts and accomplished leaders. GALS was launched in October 2015 and is located in Cambridge Innovation Center (CIC) at One Broadway.

    GALS is seeking to hire a Project Administrator to join the team in Boston/Cambridge. The successful candidate will be responsible for project administration and daily operations, and provide hands-on support for all communications and marketing activities of GALS in the US and Germany.

    Responsibilities

    Operations

    • Help GALS companies with the logistics of their stay in the US and serve as their first point of contact with any administrative questions.
    • Arrange meetings and conference calls, prepare presentations, and follow up on action items.
    • Plan and organize events such as workshops, lectures, and networking meetings in close collaboration with other team members.
    • Collect metrics on performance of GALS and create monthly reports.
    • Prepare budgetary reports and track expenses.

    Communications & Marketing

    • Establish and maintain CRM system, database, and any other digital tools that help GALS to manage its operations effectively and to stay in touch with all relevant stakeholders.
    • Create and update templates for documentation, reporting, and internal & external communications.
    • Maintain the GALS website and generate content in close collaboration with the Head of Strategy & Operations (US) and the Marketing & Strategic Partnerships Manager (Germany).
    • Collect and curate news and data relevant for GALS, participating companies, and other stakeholders such as entrepreneurs, investors, and industry partners. Share this content on various social media channels, newsletters, etc. and engage with the innovation ecosystem on these platforms.

    Your Qualifications

    • 2-5 years of experience in project administration and/or marketing in the lifecsciences.
    • Solid understanding of the life science innovation landscape based on hands-on experience in either academia or industry.
    • Strong written and verbal communication skills in English.
    • 1-3 years of experience with CMSs such as TYPO3 or WordPress and CRMs such as Salesforce, and strong business software skills (Excel, Word, PowerPoint).
    • Passion, humility, integrity, positive attitude, mission-driven, and self-directed.
    • MSc/MA degree preferred; BA degree required.

    Contact:

    Christoph Lengauer, PhD, MBA | CEO | German Accelerator Life Sciences Cambridge Innovation Center | 1 Broadway | Cambridge, MA 02142 Email: christoph.lengauer@germanaccelerator.com | Phone: +1 (617) 949-1177


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  • 01/06/16--09:00: Developer
  • Design and develop new tools for internal and external web users

    Enhance and maintain existing software tools used by the larger organization

    Build highly optimized responsive web pages and interfaces

    Create, edit or modify templates for a Django-based web platform

    Collaborate with R&D and business teams to create the best possible user experience

    Be a front-end developer who is passionate about user experience and visual storytelling

    Conduct data visualization projects for internal clients

    Proficient with a front-end javascript library (Angular.js, Backbone.js, etc.)

    Requirements

    You've developed highly optimized, responsive websites and have examples to show for it.

    You know how to slice and dice to create clean markup with the latest in HTML, CSS, and JavaScript libraries (jQuery) including:

    • Knowledge      of the semantic meaning of HTML elements.
    • Best      practices in CSS file organization and structure.
    • Knowledge      of the operators, variables, datatypes, objects, properties and methods.
    • Familiarity      with control structures such as objects, functions, conditional      statements, arrays, loops and expressions.
    • Forms      and regular expression validation and submitting data.
    • Knowledge      of how to apply logical operators and conditional statements.
    • Knowledge      of HTML objects and their properties.
    • Knowledge      of how to employ the jQuery library for visual effects, event handling,      and document manipulation.

    Methods to ensure browser & device compatibility

    Methods for degrading gracefully for older browsers and displays

    You have basic knowledge of any server-side language (PHP, Perl, Ruby, C#, etc)

    Familiarity with modifying Django templates to display data

    Understanding how to utilize Python to filter, process and output html, json, xml

    You have an eye for details that make a great user experience

    Ability to communicate with the research team, obtain requirements, find solutions and implement them in a clean and concise way

    Experience designing and developing static and dynamic visualizations (e.g. ggplot2, d3.js)

    An interest in immunology and cellular biology

    Strong quantitative, analytic and problem-solving skills

    Ability to adapt to an ever-changing environment

    Master's or Bachelor's degree in related field

     

     


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    We are seeking a highly motivated and strategic Program Manager of Early Phase Development to support the advancement of our checkpoint antibody candidates to IND and early phase clinical trials.   We are looking for an industry-experienced PM with the ability to facilitate local and cross-functional activities, apply procedural solutions to operations, and execute on project related decisions. \\Roles & Responsibilities  1. Drive CPM development candidates from lead development candidates through IND enabling programs to early phase programs and identify optimal resource allocation of development project resources 2. Provide accurate, traceable, up-to-date and consistent data as basis decision-making and planning, and transparency on portfolio risks, inter-dependencies, inconsistencies and need for alignment 3. Consult on harmonization of data sources, standardization of study designs, development project management and financial reporting tools 4. Engage multi-disciplinary and cross-functional project teams to constantly improve the ability of the organization to deliver on development commitments 5. Manage key stakeholders to increase alignment to strategic priorities 6.Ensure consistent communication of portfolio decisions and compliance to them, and ensure transparency on technology and product road-maps and their alignment with RPD strategy

    PhD Preferred

    3-5 years of professional experience, including project management, strategy development, budget development, and vendor management  • Advanced degree in life sciences (MSc/PhD preferred) or related technical discipline paired with a practical business background • Knowledge of antibody-drug development  • Solid organization and project management skills, ability to think strategically and systematically, analyze complex business issues and opportunities, and utilize sound judgment in deriving conclusions to establish the appropriate objectives and direction • Strong interpersonal skills to successfully perform in a complex global matrix environment, excellent stakeholder management skills, proven track record of consensus building and conflict management in challenging situations • Strong leadership skills in cross-functional teams with and without direct reporting lines; demonstrated ability to achieve results • Experience in multiple external partnerships in  early development and good understanding of research and laboratory operations  • Proven ability to manage multiple simultaneous projects  • Broad knowledge of research and biological testing, principles, concepts, methods, best practices  • Broad knowledge of pre-clinical in-vitro assays  • Extremely strong interpersonal skills, demonstrated ability to work in a highly collaborative environment and ability to achieve results through other managers and people  • Extremely strong written and oral communication and presentation skills


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  • 01/06/16--09:00: QC Analyst, Analytical
  • Title:  QC Analyst, Analytical

    Reference Number:  918

     

    RESPONSIBILITIES Analytical testing of in process, development, stability, raw materials and final product samples. Performance of testing in accordance with standard operation procedures. Perform job function in accordance with the Agenus Quality Policy and Manual, as appropriate. Work in compliance with cGMP’s

     

    REQUIRED TASKS Testing included but not limited to HPLC, SDS-PAGE, Western Blot, Bradford, ELISA and wet chemistry methods. Support the execution of approved protocols for the validation of analytical instruments and test methods. Revision and development of standard operating procedure, as needed. General laboratory support, including but not limited to, sample receipt, inventory control, reagent preparation and equipment and instrument maintenance. Monitoring of temperature controlled units using monitoring system. SPECIFIC SKILLS RELEVANT TO THE JOB Individual must be flexible, work well in a team environment and possess developed organizational skills. Prior knowledge of Empower software and other laboratory software preferred. Proficient in MS Office Prior knowledge of cGMPs.

     

    Requires B.S. in a scientific discipline or equivalent

     

    Minimum 1-3 years experience in a GMP laboratory environment


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  • 01/06/16--09:00: Preclinical Biostatistician
  • www.genocea.com

    Genocea Biosciences is a small fast-growing vaccine discovery and development company based in Cambridge, Massachusetts. Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines and immunotherapies. 

    Preclinical Biostatistician

    Position Summary

    We are seeking an experienced and motivated Biostatistician to join our fast-growing company to develop protein-based vaccines for the prevention and treatment of infectious diseases and cancers. The successful candidate will provide significant statistical expertise in preclinical study design and data analysis in the vaccine development and discovery research. He/She will also provide support and collaboration in analyzing large and complex data sets generated by Genocea’s ATLAS platform. The Biostatistician will have the opportunity to work on developing novel statistical methodologies and/or improve the current methodologies. He/She will contribute to the science through independent and collaborative research resulting in presentations and publications.

    Responsibilities

    • Serve as key biostatistician on preclinical study design and data analysis to identify novel protein candidates for vaccines
    • Help build statistical capabilities in vaccine development and discovery research by providing strategic input to analyze large and complex data sets from high throughput platforms.
    • Maintain and expand expertise in various computing tools to leverage internal and external data sets to drive decisions.
    • Develop and maintain good working relationships with discovery and clinical scientists, statisticians, computational biologists, and external collaborators to drive program decisions as part of a multidisciplinary team.
    • Proactively seek input and review from other experts within and outside the group on various projects and research activities, and share technical information when appropriate.
    • Propose opportunities for productivity improvements and implementation plans.

    Required Skills

    • Strong basis in statistical concepts and expertise in statistical methodologies such as predictive modeling and inference, machine learning methods, mixed effects models, multivariate analysis, etc.
    • Strong statistical programming skills with standard software, including R and SAS
    • Excellent communication, presentations and report writing skills, and the ability to explain complex technical details in simple language.
    • Work well in a team as well as independently, and be able to take leadership role with regard to methodological elements in projects.
    • Background in immunology and oncology would be a great asset
    • Background in analyzing high-throughput dataset would be a plus

    Education & Experience Required

    • PhD in Biostatistics or Applied Statistics
    • >1 year relevant academic/industry experience on topics related to immunotherapy, oncology, drug discovery, clinical genomics or other applications

    To apply for this position, please CLICK HERE


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