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Career postings for the Massachusetts Biotechnology Council

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    Our client is a fast growth biologics company that is seeking a Sr. QA specialist. The qualified candidate will be responsible for establishing, maintaining and updating quality systems and documentation to ensure compliance with regulatory and company standards.

    Responsibilities

    • Participate in setting up and maintaining quality systems that are compliant with applicable clinical regulations and standards
    • Monitor and approve in process testing
    • Review and approve of Batch Records Schedule and perform internal and external audits
    • Administer the Deviation and CAPA program
    • Revise QA SOPs
    • Release Raw Materials and In-House Finished Products

    Requirements

    • Bachelors of Science in related discipline
    • A minimum of 2 years of experience in a Quality Assurance role in the medical device, pharmaceutical or biotech industry
    • Strong initiative and ability to work with minimal supervision in the laboratory
    • Fluency in Windows and Microsoft Office (Word, Excel, Access, Powerpoint)
    • Strong verbal and written communication skills
    • Strong analytical ability and project management skills
    • Able to multi-task with a strong attention to detail

    Please send resume to: mdaniel@biomedicalsearch.com

    For more information, please visit: www.biomedicalsearch.com


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  • 11/07/12--00:38: Business Development Manager
  •  Business Development Manager.

        Discovery Life Sciences, Inc. seeks a highly motivated, proven sales and business development professional for our exciting, highly entrepreneurial business environment who can thrive in our fast paced, multi-functional clinical research products and services organization.  

     The candidate for this position will be self- motivated to achieve high levels of sales production, disciplined to develop solid long term business relationships and have the ability manage multi-point communications for complex service programs.

     The candidate for this position will believe in a consultative sales approach and working closely with our CEO/Senior Management and clients in the Life Sciences Industry (Bio-Pharm, Medical Device and Biotechnology) to advance business opportunities.  

     The candidate will be responsible for every phase of sales management: lead generation, account introduction, needs assessment, quote generation (assisted by internal resources), program negotiation, and relationship management.

     Discovery Life Sciences is a service driven corporation therefore , excellent communication and interpersonal skills are essential.

     Qualifications:

    + Bachelor’s or Master’s Degree Biology, Biochemistry or related scientific discipline.

    + Strong Business Skills and Communication Skills are Essential.

    + 5 or more years of proven sales experience selling clinical research services, research products or related research products to Life Science, Biotech, and Bio Pharmaceutical industry clients.

    + Competitive salary and benefits package commensurate with experience and qualifications. 

     Send resumes to: humanresources@discoverylifesciences.com     

    Contact name: Steven Raia

    Position Location: Boston, MA.

    Web: www.discoverylifesciences,com

     


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    Our client, with proficiency and market leadership in the creation and commercialization of novel molecular based diagnostics, has an immediate need for a Senior Scientist to join their team as the liaison between product development and manufacturing to transition the products from product development to manufacturing.  This is an exciting opportunity to play a critical role in multiple product development teams providing scientific and technical input throughout all phases of product development including; final assessment of product development documents, review of product design, designing studies to support product performance, and identifying product performance and use requirements to draft product Instructions for Use.

    This position requires a BS in Molecular Biology with a minimum of ten years industry experience, with at least five years at a Senior Scientist level responsible for independent product development.  Additional requirements include experience with PCR technologies (including RT-PCR), Quality Assessment System for IVD Class I devices, regulatory processes associated with FDA 510(k) filings as well as experience with technology assessment for molecular assay development and for the development of nucleic acid test platforms.           

    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.

    StratAcuity, CHEMISTRY IS EVERYTHING.


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  • 11/07/12--01:47: Administrative Assistant
  • Administrative Assistant

    We are seeking an experienced and enthusiastic administrative assistant to support our growing and dynamic company. This is a fast paced environment where an individual needs to adapt quickly to changing deadlines and priorities while demonstrating a positive, "can-do" approach.

    Duties and responsibilities

    • Manage the reception area
    • Telephone – handle incoming and outgoing phone calls as directed. Transfer and screen calls for the team as needed.
    • Meet and greet guests and visitors
    • Coordinate visitor needs
    • Coordinate deliveries, mail distribution, FED EX/UPS shipments, couriers, etc.,
    • Set up internal meetings: book rooms, provide refreshments, provide needed supplies
    • Assist in scheduling and coordinating candidate interviews
    • Set up newly hired employees with basic office supplies and facility access badges
    • Order supplies and manage inventory
    • Interface with landlord, building management, and others to coordinate repairs, move furniture, assemble office items, etc.
    • Maintain phone and email lists
    • Assist with various projects as assigned

    Requirements

    • Bachelor’s Degree or equivalent combination of education and experience with a minimum of two years directly related experience.
    • Positive, engaging,  “customer-service” approach is required
    • Ability to multi-task
    • Good communication skills
    • Strong organizational skills
    • Should be detail-oriented
    • Working knowledge of Microsoft Office software

     


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    ImmunoGen Inc. is seeking a Quality Control Analyst that will provide support for environmental monitoring, water system testing, and various microbiology laboratory testing activities in compliance with c-GMP's. This position will also maintain the laboratory testing areas, equipment, and supporting documentation for routine activities.  This position will also provide support for basic biochemical assays.  This position requires flexibility with changing priorities.

    Job responsibilities include but not limited to the following:

    • Performs environmental monitoring in classified cleanroom manufacturing areas testing for non-viable particles, viable airborne bacteria, and viable bacteria on surfaces
    • Samples and tests high purity water systems, and clean steam generators for bioburden, endotoxin, Conductivity, and TOC analysis
    • Performs bioburden testing of raw materials, in-process materials, and product materials
    • General laboratory support activities include reagent prep, equipment maintenance, growth promotion of culture media
    • Perform routine biochemica testing of products and intermediates

    BS degree in appropriate Biological Science plus at least1-2 years experience in EM monitoring and microbiology assays or a HS degree with an AA or AS associate degree in an appropriate field with 2-5 years experience.  Must also be able to don & work in cleanroom garments, able to lift 25 lbs, and possible evening and weekend work may be required.

    ImmunoGen, Inc. offers an excellent salary and benefits package including 100% paid health and dental insurance, 401(k) and tuition assistance.  Please send a detailed resume to: resumes@immunogen.com

    We are an Equal Opportunity Employer


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    ImmunoGen Inc. is seeking a Quality Control Analyst that will demonstrate a leadership role in QC, provide technical support for group members, applies knowledge of industry for problem solving and decision making.  This position requires the ability to work independently on moderately complex problems, assists with routine non-conformance issues, trains group on routine activities, independently identifies problems and communicates solutions, and consistently demonstrates technical proficiency and quality in their work.  

    Job responsibilities include but are not limited to the following: 

    • Performs environmental monitoring in classified manufacturing areas
    • Performs testing of raw materials, in-process and final product for endotoxin content, bioburden, and bacterial identification of isolates
    • Reviews data generated from internal and external testing
    • Train group members on routine activities, may train group members on more complex methods/instrumentation and provide technical direction
    • May act as project coordinator for reporting, prepares or writes reports
    • Works indepedently on complex assignments that require creative solutions and highly skilled techiques 

    A/BS degree in appropriate scientific field, a minimum of 4-6 years related experience in c-GMP regulated industry, or a High school/equivalent, certificate program or an AA/AS degree in a related field, 6-8 years related experience. Must be able to don cleanroom garments, able to lift 25 lbs, and may require evening and weekend work. 

    ImmunoGen, Inc. offers an excellent salary and benefits package including 100% paid health and dental insurance, 401(k) and tuition assistance.  Please send a detailed resume to: resumes@immunogen.com

    We are an Equal Opportunity Employer


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  • 11/08/12--09:00: Research Associate
  • The Cystic Fibrosis Foundation, a highly regarded national voluntary health services agency, is seeking a research assistant/associate for a new laboratory that is being established in the greater Boston area. The focus of the laboratory is on assay development and early discovery of molecules that can modulate expression and function of mutant CFTR protein, and that may eventually lead to new treatments for Cystic Fibrosis (CF). Applicants for this position are expected to perform cell culture work and cell-based electrophysiological assays.

    The ideal candidate will have a BS/MS degree in biological sciences and 2+ years of relevant experience in the biotechnology industry or academia. The candidate will join a small group of highly motivated scientists that work at the fore-front of CF research.  Hands-on experience with mammalian cell culture is required and the candidate is expected to independently perform routine tasks within a few weeks.  Experience with lab automation systems and in particular liquid handlers is considered a plus. 

    For immediate consideration, please visit the employment section of our website www.cff.org under jobs located in Boston and submit your resume, cover letter and salary requirements. You may also paste the following URL into your browser to be directed to the applicant page: http://tbe.taleo.net/NA12/ats/careers/requisition.jsp?org=CFF&cws=1&rid=2159


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    Reporting to the SVP of Corporate Strategy & Business Development, the Sr. Director, Search and Evaluation will generate deal flow through the identification and initial business fit and scientific evaluation of potential strategic opportunities for Vertex to in-source, including complementary assets and new technologies. Sourcing of new opportunities will involve a broad Vertex outreach that will include the Venture Capital community, early stage biotech companies, opportunistically larger pharma and biotech companies, and scientific and partnering conferences, among other sources.

    Key Responsibilities:
    - Lead therapeutic area and/or technology focused sourcing projects aimed at identifying in-licensing and/or acquisition opportunities.
    - Be Vertex’s initial interface with VCs, their portfolio companies and other early stage companies. Similarly interface with large pharma and biotech (in close coordination with the Business Development Execution team), where relevant, to monitor the availability of potential opportunities for Vertex to insource.
    - Create a presence at key scientific and partnering conferences and in coordination with the Business Development Execution team, develop a “Vertex Partnering” message and collateral to increase profile of the Company and its in-sourcing goals, at such meetings.
    - Conduct initial high level business fit and scientific evaluation of potential opportunities to determine if they are worthy of further, detailed functional evaluation.  If yes, work in a highly coordinated fashion with Business Development Execution team to transition opportunity in a manner that will appear seamless to the potential partners.
    -Ensure that the transition to the Business Development Execution team includes a thorough transfer of all early findings/learnings/considerations (relating to scientific, business and personality aspects, as applicable). Remain involved until such a point at which the Business Development Execution team feels there has been both a seamless transition from the partner’s point of view and that the full “learnings transfer” has occurred

    REQUIREMENTS:
    - PhD Required (MD PhD preferred)
    - A minimum of 5 years in a venture capital or business development role

    Preferred Qualifications:
    - Able to work independently, as well as part of a team.
    - Critical thinker with sound scientific and business judgment
    - Visionary – able to look beyond what is “on paper” in determining the potential of a program
    - Strong interpersonal skills, ability to:
    - Deliver company message and goals to outside parties (at both the scientific and business level)
    - Build and maintain relationship with the VC community, other biotech companies and other potential sources of opportunities
    - Able to assemble, synthesize and summarize a complex set of facts and assess how an opportunity may fit within the broader competitive and strategic context.
    - Adept at handling multiple projects in parallel and tight deadlines in a fast-paced environment.
    - Strong project management, presentation and communications skills.
    -Embody the Vertex Core Values of Uncompromising Commitment to Patients, Fearless Pursuit of Excellence, Innovation is Our Lifeblood and “We” Wins
    -Effective communication skills, both verbal and written
    -Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
    -A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society

    Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.

    Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

    To Apply for this position, please CLICK HERE


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  • 11/08/12--03:43: Quality Control Scientist I
  • Position Summary
    This position is responsible for performing routine and complex techniques associated with daily QC use and maintenance of laboratory equipment. It provides an in-depth investigative and technological orientation in implementing, executing and interpreting quality procedures. Successful candidate will substantially contribute to process and method improvements within the Quality Control laboratory.

    Core Responsibilities

    • Perform maintenance on complex laboratory equipment including HPLC and GC systems.
    • Investigate and troubleshoot Quality Control methods related to instrument issues.
    • Review QC equipment qualification and maintenance records for compliance to procedures and specifications.
    • Participate in training of less experienced staff on new technology.
    • Qualify and implement new equipment and technology from support groups to the QC laboratory.
    • Formulate solutions to laboratory issues through testing of hypotheses.
    • Develop and author complex and explicit documentation for new and current procedures and technical reports.

    Provide technical leadership and guidance for the successful completion of major laboratory
    projects:

    o Implement new quality control procedures.
    o Identify deviations from QC methods and develop appropriate CAPAs.
    o Recommend laboratory and equipment-related improvements.
    o Contribute substantially to the interpretation of equipment qualification and troubleshooting.
    o Work effectively with others to achieve shared goals and meet timelines.
    o Interact with internal and external personnel on technical matters requiring coordination between sites.
    o Work independently with minimal to no supervision and direction.
    o Work in compliance with cGMPs.

    Practice safe work habits and adhere to Genzyme's safety procedures and guidelines.

    Leadership Qualifications:
    An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services.

    This includes:
    • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
    • Being honest and treating people with respect and courtesy.
    • Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products.
    • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

    Basic Qualifications:
    • Bachelor's Degree in Life Sciences discipline and 6 years experience in cGMP lab environmentOr
    • Master's Degree in Life Sciences discipline and 4 year experience in cGMP lab Environment.

    Preferred Qualifications:
    • Proficient in MS Office and lab based data management systems.
    • Ability to present technical data.
    • Ability to work independently on scientific projects.
    • Familiarity with USP and global compendial regulations.
    • Scientific technical writing ability including authoring and revising SOPs or technical reports.
    • Experience troubleshooting of assay and equipment issues.
    • Experience with Dionex, GC, HPLC, Gel Electrophoresis, UV Vis Spectroscopy and wet Chemistry.
    • Experience with Empower software.

     

    To apply for this position, please CLICK HERE


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    Vertex Pharmaceuticals is currently searching for a Medical Director to join the Clinical Development team to assist with the advancement of several programs currently in the drug development process.

    The Medical Director serves as Medical Monitor for Clinical Trials, ensuring compliance with GCP regulations and monitoring the safety of enrolled subjects. Generally works on multiple trials or more than one program at a time comprised primarily of Phase I, Phase II, or Phase III studies. In this position you provide program level clinical support across multiple programs with a respiratory focus. Depending on experience level, the Medical Director could potentially oversee development strategy for any one of our exciting compound(s), align with the broader strategy and needs of other related projects, and coordinate the clinical studies to be carried out in support of the development plan for this compound(s).

    Key Responsibilities
    - Act as the Medical Monitor for clinical trials
    - Develops clinical protocols, investigator’s brochures and clinical development plans (in coordination with the Clinical Program Manager) with emphasis on scientific and safety matters, with minimal guidance
    - Represents Vertex to outside medical/scientific experts in the development of the clinical protocols, solicitation of input and opinion, and presents at conferences and symposiums
    - Utilizes novel and creative methods to resolve clinical development problems independently
    - Acts as liaison between clinical development department and internal regulatory affairs for assigned programs
    - Be a direct participant in clinical trials
    - Contribute to the production of regulatory documents such as IND filings, IND annual reports and EU regulatory submissions
    - Be the primary Vertex liaison to academic medical experts and investigators

    Depending on experience level, other responsibilities could include:
    - In conjunction with other relevant functional areas, develop the strategic development plan for a compound(s)
    - Act as the international clinical lead for the compound to both internally and externally facing stakeholders by providing high level input
    - Oversee the writing of protocols, the conduct of trials and the analyses of data for this compound
    - Interface with international regulatory authorities, as appropriate, in support of the development objectives for the compound and assist Regulatory Strategy staff in the compilation of submissions and in the responses to inquiries
    - Serve as a leading member, or participant, at multiple internal review groups and utilize novel and creative methods to resolve clinical development problems independently
    - Assist in the hiring, recruiting and retention of key high caliber staff in support of the development project(s)
    - Ensure compliance with Vertex SOPs, ICH, GCP and other national and international regulatory requirements
    - Draws esteem and renown to the company from outside clinical, technical and business communities
    - Ensures alignment of development strategy for a compound(s) with other projects within the therapeutic franchise area

    REQUIREMENTS:
    - MD, DO or equivalent ex-US medical degree
    - 5+ years of basic or clinical research experience in an academic or industrial setting with experience in publications
    - 3+ years of experience in the pharmaceutical industry
    -Experience in filing and defending US IND's or similar ex-US regulatory submissions
    - Clinical drug development experience and excellent communication skills
    - Ability to work collaboratively in a team-based matrix management environment with minimal supervision
    - Possess a full understanding of applicable US and EU drug development regulations and GCP regulations
    - Have a working knowledge of biostatistics and pharmacokinetics
    - Experience in interactions with regulatory authorities

    Preferred Qualifications
    -Training in Respiratory/Pulmonary

    Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.

    Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

    To Apply for this position, please CLICK HERE


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    Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

    Quality Control Microbiology supports manufacturing activities at Genzyme's Framingham Campus by detecting, quantifying and identifying possible contaminants that may interfere with the quality of the product during the different stages of the manufacturing process. It aims to maintain a state of microbiological control in the Utility systems and within the environment where the manufacturing process is executed. It assesses the aseptic behavior of the personnel involved in these processes; and contributes to the guarantee that the end product will meet the pre-defined standards for safety, purity, identity and effectiveness.

    Budget
    - Provide input into the department budget.
    - Manage departmental budgetContinuous Improvements- Work collaboratively with inter-department and cross-functional teams to lead changes in a timely and effective manner.
    - Identify opportunities to improve Quality processes and practices.
    - Ensure Quality management tools/systems and documentation (SOPs, MBR's, OJTs) are accurate.
    - Position SummaryThis position provides key leadership and direction to the Microbiology department while providing Microbiological expertise and support to Manufacturing and Quality operations on-site.

    Core Responsibilities
    - Maintain a safe, efficient, functional and compliant laboratory developed to the required standards in accordance with site and corporate guidelines.
    - Provide microbiological expertise and support for product investigations, improvements, etc. to ensure continued compliance with regulations.
    - Develop and implement Quality Control systems for Framingham Microbiology lab.
    - Oversee day to day operations of QC Microbiology lab, and effectively interacting with Manufacturing, Quality, MTS & other groups.
    - Provide Microbiological assurance technical oversight as required.
    - Additional Responsibilities

    Staff Management
    - Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
    - Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
    - Coach and mentor staff in all aspect of their job performance and career development including training, feedback, rewards and disciplinary action.
    - Develop work plans, assign tasks, and supervise a large team or multiple small teams.
    - Manage staff requirements based on CQO corporate projects.
    - Provide organizational and managerial structure that supports the various levels in the organization.
    - Ensure timely issue escalation to Quality senior management and cross-functional support teams.
    - Maintain staffing levels and meet approved hiring plans.

    An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services.

    This includes:
    - Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
    - Being honest and treating people with respect and courtesy.
    - Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products.
    - Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

    Leading People
    - Genzyme's leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers.

    Leading the Business
    - Genzyme's leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.

    Delivering to Customers
    Genzyme's leaders understand patient and customer needs and build relationships as required to meet manufacturing goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence.

    - In collaboration with the Director participates in strategic planning and corporate development activities to include presentation of information related to quality assurance, internal capacity, timelines for implementation and corporate direction.
    - Align department objectives with CQO business objectives.
    - Collaborate with senior leadership team in meeting corporate and CQO goals.
    - Establish key performance indicators, maintain, and report applicable department or organizational metrics.
    - Sponsor and direct the development of projects and conducts follow-up and reporting.
    - Represent business unit in Project Team meetings related to global initiatives.
    - Interact with project teams and research groups as they impact the quality operation.
    - Perform internal audits of the SOPs and documentation related to QS Enterprise Systems and other functions that receive CQO QA oversight.
    - Support CQO in the creation, training, and implementation of Corporate Quality Standards.
    - Interface with external regulatory agencies.
    - Ensure projects are managed in compliance with all Genzyme and legal requirements.
    - Ensure all Micro lab operations meet current cGMP and Corporate compliance requirements aligned with "Lean lab" philosophy.
    - Utilize quality systems to measure, analyze, and improve team performance.
    - Design department training plan and manage execution.
    - Manage Investigations and CAPA for major and critical deviations.
    - Ensure minor, major and critical deviations are closed in a timely manner.
    - Participate in inspections conducted by external regulators.
    - Comply with requirements from Genzyme's Safety Program including Health and Safety regulations and OSHA requirements.

    BASIC QUALIFICATIONS
    - 15 plus yrs experience in Quality Control operations including experience in cGMP and pharmaceutical quality systems.
    - 10-15 years management experience.

    PREFERRED
    - Bachelor's Degree in a scientific discipline Experience in project management and microbiology.
    - Excellent communication skills both verbal and written.
    - Effective time management and organizational skills.
    - Strong attention to detail and cross functional team experience.
    - Strong leadership skills, ability to drive accountability, compliance and efficiency throughout the department.

    To apply for this position, please CLICK HERE


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  • 11/08/12--03:54: Sr. Advisor to the CSO
  • This is a newly created role of Senior Scientific Advisor who would work with the Broad Institute’s Chief Scientific Officer to help chart the scientific course of the Institute. We are looking for a self-motivated individual with scientific breadth and the ability to interact with the Broad’s diverse scientific community to identify new scientific opportunities, help develop plans for new initiatives, and help with the scientific assessment of existing research activities. The incumbent will assist the CSO in his responsibilities of facilitating the development and articulation of the overall scientific vision for the Institute, overseeing scientific review of Programs and Platforms, and helping to evaluate priority of specific goals and investments of the Institute. The ideal candidate will also act as ambassador for the CSO within and outside of the Broad Institute, serving as a primary CSO contact for all Broad programs, platforms and initiatives.

    CHARACTERISTIC DUTIES
    - Works with the CSO to evaluate scientific opportunities - by working ideas with members of the Broad scientific community, and assessing external experience. Prepares written reports of assessments and recommendations.
    - Assists the CSO in monitoring specific projects - by staying informed of scientific progress of key Institute activities, and reporting on progress.
    - Works with other Institute leaders to help solve organizational challenges that impact Broad research.
    - Works with research groups (directed by faculty members who are independently responsible for their own labs) to understand their scientific vision and goals, and help them to realize them. Also works to align those goals with Institute goals and priorities, and, when relevant to identify research capabilities that might be made more broadly available across the Institute.
    - Advises CSO on the implementation and status of plans and goals; recommends shifting of priorities as necessary.
    - Drafts grant proposals to government agencies, foundations and biopharmaceutical companies, and drafts progress reports for same.
    - Helps prepare CSO for key presentations and deadlines.
    - At various times, represents the Institute at scientific conferences and other engagements; may also include speaking and presenting on behalf of the CSO.
    - Functions as a key resource for the development of the Institute’s current scientific goals, priorities and obligations to funding sources.
    - Performs other related responsibilities as necessitated by the position.

    - M.D. or Ph.D. in biomedical research, with post-doctoral training and demonstrated scientific contributions to the field.
    - Post graduate leadership and supervisory experience preferred.
    - A minimum 10 years of research experience, with a track record of scientific accomplishment.
    - Must have very strong scientific writing skills.
    - Ability to adjust to rapidly changing scientific priorities and technologies.
    - Excellent communication skills (both in writing and presenting), analytical, and interpersonal skills.
    - Must demonstrate outstanding personal initiative and the ability to work effectively as part of a team.

    To apply for this position, please CLICK HERE


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    ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.

    Summary 

    The Director, Analytical Development is responsible to ensure that all analytical requirements for ARIAD’s drug substances and drug products are proactively identified and addressed to meet the regulatory and business needs in context with the global development and commercialization of ARIAD’s small molecule oncology products. The Director, Analytical Development provides leadership and direction to all internal and external contributors engaged in the analytical development of ARIAD’s clinical and commercial products. This includes substantial hands-on involvement and authoring of documentation, as well as constructive and productive partnering with other departments and companies. In addition to directing the personnel within the Analytical Development department, the Director guides cross-functional activities in close collaboration with ARIAD’s analytical sciences, process development, formulation development, manufacturing and quality functions. The Director, Analytical Development guides and coordinates the analytical activities at contract labs and contract manufacturers on multiple continents to meet the analytical, quality and regulatory requirements on time and on budget.

    Duties and Responsibilities

    The major duties and responsibilities of the Director, Analytical Development, include, but are not limited to:

    • Lead the integration of analytical methodology and concepts in QbD for DS and DP development
    • Provide effective Analytical Knowledge management for development and commercial products
    • Perform analytical method development & validation for key intermediates, DS & DP
    • Ensure effective characterization of key intermediates, DS & DP
    • Perform comparability assessment of key intermediates, DS & DP upon tech transfer, process improvement & scale-up
    • Ensure effective design & execution of stability studies for DS & DP
    • Lead effective specification development for DS & DP
    • Provide QC support & data review
    • Provide analytical support of process & formulation development
    • Author of reports & CMC sections for IND & NDA
    • Direct the personnel and activities within the Analytical Development department
    • Lead cross-functional analytical development activities in close collaboration with ARIAD’s analytical sciences, process development, formulation development, manufacturing and quality functions
    • Guide and coordinate the analytical activities at contract labs and contract manufacturers on multiple continents to meet the analytical, quality and regulatory requirements on time and on budget
    • Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
    • Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization. 

    Requirements

    • Ph.D. in analytical sciences with emphasis on small molecule organic chemistry and pharmaceutical process chemistry.
    • Minimum of 15 years relevant experience in the pharmaceutical industry, at least 5 years at Director level.
    • Experience with strategic planning for accelerated development of clinical candidate compounds
    • Experience with writing portions of the CMC sections of Regulatory filings
    • Experience with key intermediates and active pharmaceutical ingredients
    • Comprehensive analytical GMP experience with both drug substances and drug products.
    • Analytical development experience with both clinical and commercial products.
    • Experience in analytical support of process development and formulation development.
    • Excellent verbal and written communication skills.
    • Experience with oncology medicines would be a plus.
    • Proven ability to fulfill the overall role summarized above and successfully meet the above described duties and responsibilities under tight timelines
    • Strong commitment to business ethics
    • Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.



    Submitting a resume online at a job site could cause valuable screening information to be missed.

    Click here to apply:

    http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=207&company_id=16419&version=1&jobboardid=306

    ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.


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  • 11/08/12--07:56: IT Project Manager
  • Position Summary

    Oversee the information technology roadmap and resources including the selection and maintenance of software applications ensuring compliance with FDA and other regulatory agencies.   

    Responsibilities

    •  Prepare and maintain IT plan for the company. 
    • Identify systems requirements and propose software purchase and installation schedule.
    • Work with user groups to define needs, design and implement new computer related systems appropriate to the changing business needs of the company. 
    • Work with Systems Administrator to enhance, maintain and document system operations providing database administration, custom reports and end user support.
    • Document procedures and protocols necessary to meet CFR Part 11 standards.
    • Advise management team on requirements.
    • Coordinate implementation teams including vendors for new software installations.
    • Provide end user support assisting with questions about systems and provide user training.
    • Interface with RA/QA and users to determine validation needs. 
    • Maintain procedures and protocols for systems.
    • Oversee service(s) provided by outside systems and programming firms.

     Education and Experience Required

    •  BS in Computer Science or a related field required
    • Minimum 8-10 years related experience preferred
    • Experience with cGMP validation requirements highly preferred

     Skills Required

    •  Broad skill base related to all software applications commonly used by life science companies
    • Strong interpersonal skills
    • Strong verbal and written communication skills
    • Ability to work independently and as part of a team
    • Strong organizational and prioritization skills

    Please click here to apply: 

    https://home.eease.adp.com/recruit/?id=2887521


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    With supervision, assist in developing and executing clinical research studies in compliance with applicable regulations. Execution of activities with direction and assistance as guided by project priorities, timings and quality specifications. Most activities will utilize the services of a CRO

    • With assistance write protocols, clinical study reports, clinical investigational brochures and clinical sections of government submissions
    • Initiate, monitor and close out clinical studies
    • Ensure timely collection and maintenance of study documentation files and all assigned duties
    • Design,prepare,plan ,implement and review clinical trial while ensuring GCP ,regulatory and ethical standards-
    • Knowledge of GCP and Regulatory compliance
    • Excellent written and verbal skills
    • Effective communication with KOL's and CRO's
    • Organize workload with project priorities and execution
    • Able to work in a group as well as independently
    • Willing and able to travel

    Qualification Requirements

    • Bachelor's degree or higher with 2-5 yrs. experience in clinical research.

    Candidates must live local and be a US Citizen or Green Card Holder

    Email resume to: jobs@cwsciences.com

    Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

    Commonwealth Sciences, Inc.

    www.cwsciences.com

     


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    Looking for a candidate to assist the lab manager in supervising a small chemistry group.  Responsibilities will include training of technicians, troubleshooting issues that arise and keeping the team on track.

    Requirements:

    BS/MS Chemistry/Biochemistry with 5 years of lab experience

    Supervisory experience is a must

     

    Candidates must live  local and be a US Citizen or Green Card Holder

     

    Email resume to:  jobs@cwsciences.com

     

     

     

    Commonwealth Sciences is  a professional recruiting firm specializing in science, engineering and green  technologies. We unite industry professionals with exciting career opportunities  by leveraging our technical expertise,advanced recruiting  tools and years of staffing experience. CWS works with a variety of  disciplines and levels from Research Associates to Scientists, Engineers,  Managers and Directors. Our clients value the basic integrity, customer service  and industry expertise that defines our organization.

     

     

     

    Commonwealth  Sciences, Inc.

     

    www.cwsciences.com


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    Looking for a candidate to join a chemistry lab to perform routine analytical testing.

    Requirements:

    BS Chemistry/Biochemistry with 2-3 years of laboratory experience, MS Chemistry/Biochemistry 0-1 year of laboratory experience

     

     

    Candidates must live  local and be a US Citizen or Green Card Holder

     

    Email resume to:  jobs@cwsciences.com

     

     

     

    Commonwealth Sciences is  a professional recruiting firm specializing in science, engineering and green  technologies. We unite industry professionals with exciting career opportunities  by leveraging our technical expertise,advanced recruiting  tools and years of staffing experience. CWS works with a variety of  disciplines and levels from Research Associates to Scientists, Engineers,  Managers and Directors. Our clients value the basic integrity, customer service  and industry expertise that defines our organization.

     

     

     

    CommonwealthSciences, Inc.

     

    www.cwsciences.com

     

     


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    Moderna Therapeutics is the first biopharmaceutical company dedicated to the discovery and development of a new class of drugs, NativeTM proteins therapeutics. Leveraging the natural way in which proteins are made by humans, our proprietary modified messenger RNA (mRNA) enables the patient’s protein translation machinery to synthesize therapeutics without inducing an innate immune response.  This approach envisions dosing a patient with stable, modified RNA that encodes a therapeutic protein of interest, that upon translation in a cell type, results in therapeutic treatment with high efficacy, low immunogenicity, and more biologically relevant dosing. The technology alleviates the need for laborious and expensive in vitro tissue culture or protein manufacture and purification.  Our manufacturing process is cell-free.  The technology is therefore a quantum advance in the field of drug development with great promise for novel ways of treating disease with direct application in the worldwide market of therapeutic biologics, which includes peptides, proteins, and antibodies.  We are looking for smart, committed individuals who are looking to change the world by bringing new drugs to patients.

    Overview: The Chemistry Manufacturing and Controls (CMC) group is looking for a Manufacturing Associate to help in the production and purification of materials for research use. 

    Reports To: Manufacturing and Quality Manager

    Responsibilities:

    • The candidate will be responsible for the operation and development of a high-throughput robotics platform capable of producing 90 novel therapeutics per day
    • Utilize automation to increase manufacturing throughput
    • Perform purification of research materials by a variety of methods
    • Conduct molecular biology analytical assays as necessary
    • Record experiments routinely and at a high level

     Requirements:

    • The ideal  candidate will have a BS degree in Biochemistry, or Molecular Biology 
    • Molecular biology experience (nucleic acid purification, PCR, in vitro     transcription, gel electrophoresis, bioanalyzer) is required 
    • Experience with automation, both operation and development/script     writing/troubleshooting, is required 
    • Impeccable attention to detail and ability to problem solve required 
    • Five plus years of industry experience is a must 
    • GMP experience in a biotech or pharma company 
    • Excellent documentation skills necessary 
    • Working as part of cross functional teams, the candidate must be comfortable presenting data in a variety of settings and with coworkers at a variety of levels

     Preferences:

    • The candidate should be outcome-oriented and attentive to detail with strong analytical and communication skills 
    • Candidate must be able to work independently

    PLEASE APPLY ON LINE BY FORWARDING YOUR RESUME WITH COVER LETTER

    Moderna Therapeutics is an equal opportunity employer, welcoming diversity in our workforce.


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    Commonwealth Sciences, Inc. is a Boston area recruiting firm specializing in life sciences, engineering and green technologies. We work with scientific and engineering professionals at a variety of levels and disciplines primarily in the Biotechnology, Pharmaceutical, Medical Device and Green Technology industries.  

    We are currently seeking energetic, outgoing individuals to join our growing business as a Sr. Account Manager / Scientific Recruiter. Responsibilities include developing new business with pharmaceutical, biotech, engineering and green technology companies through inside and outside sales activities including lead generation, cold calling, networking and marketing campaigns. Activities require extensive phone work and coordinating multiple activities. Duties also include sourcing and recruiting technology candidates through the internet, networking events, call marketing, job fairs and campus recruiting.  

    Commonwealth Sciences offers an ethical and entrepreneurial atmosphere where your independence, creativity and drive can develop and flourish. We invest heavily in the latest recruiting tools and technology to optimize your ability to compete and succeed in a competitive market place. We also offer one of the most lucrative commission plans in the business.  

    Qualifications must include a Bachelor's Degree in a technology or business discipline with outstanding communication and interpersonal skills. Candidates must have experience in sales and/or recruiting in the life sciences, engineering, high-tech or staffing industry with a stable and proven track record. Candidates must have a strong drive and work ethic with the ability to operate independently in a fast paced environment. Local candidates are highly preferred. 

    Candidates must live local to Norwood MA

    Recent Graduates with an interest in technology sales are encouraged to apply.

    Email resume to: rick@cwsciences.com 

    Commonwealth Sciences, Inc.

    www.cwsciences.com


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