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QA Associate: GMP

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Expectations -
• Perform product changeover inspections
• Review and approve cleaning logs, calibration records, charts
• Issue batch records
• Inspect packaging of material for shipment
• Prepare labels for shipments and disposition material
• Coordinate document control functions
• Maintains current guidance library
• Prepares COAs for signing

Education/Experience/Requirements -
• Requires Bachelor’s Degree in science or equivalent with 0-2 years of relevant experience in a GMP environment.
• Some experience with Quality Assurance support for all phases of clinical trials.


VP / SrDir Business Development

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Acetylon Pharmaceuticals Inc. was formed in 2008 to commercialize innovative drug discovery technology emerging from collaborative research at Harvard University and the Dana-Farber Cancer Institute.  Acetylon is pursuing clinical development and commercialization of next generation, selective, small-molecule Histone Deacetylase (HDAC) inhibitors with enhanced therapeutic effectiveness and improved safety profiles.  Our lead drug candidate, ACY-1215, is an oral small molecule inhibitor of HDAC6 currently in Phase Ib clinical trials in multiple myeloma in North America.  The company has several additional pipeline programs for the development of selective HDAC inhibitors for neurodegenerative and inflammatory diseases, sickle disease and beta-thalassemia, and parasitic diseases which are approaching clinical development.  Acetylon has raised $55M to date from private investors, The Leukemia and Lymphoma Society, and Celgene.  Acetylon is located in a newly built facility in Boston's Seaport District / Innovation Zone.

We are seeking highly talented, motivated and energetic team members to join us in building our company and advancing our exciting therapeutic opportunities.

Open Position Title:  Vice President / Senior Director of Business Development

Responsibilities:

  • Direction/completion of corporate partnering / outlicensing projects
  • Collaboration with senior R&D staff to in-license/acquire new technology
  • Cross-functional leadership, coordination and negotiation of transactions
  • Evaluation/analysis of new business opportunities
  • Leadership of annual strategic planning cycle
  • Management team member, reports to President & CEO
  • Level of position is TBD commensurate with background

Background:

  • 5+ years experience in life sciences business development
  • Substantial experience developing and closing major partnering/licensing transactions
  • Current knowledge of pharmaceutical companies, prescribed drugs and medical practices in oncology and neurodegeneration is desirable
  • MBA or equivalent training in financial/strategic analysis required; Ph.D. in biology or chemistry preferred
  • HIgh energy, creativity, analytical intellect, and strong interpersonal and teamwork skills essential

Senior/Principal Scientist - Process Development CMC

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This position provides an opportunity to join a growing Drug Development Department and contribute substantially to the successful characterization, scale up, and manufacturing of novel CNS medications. In addition, there is an opportunity to expand your knowledge in the field of CNS research through day-to-day activities and close interactions with the Research and Clinical groups within EnVivo.

As a member of the CMC Drug Development Team, you will work closely with the Principal Scientist of Process Development on  the identification, technology transfer as well as scientific and project management of external CMC vendors.  In addition, the candidate will work with both the CMC and quality teams to ensure that high quality clinical trial materials and regulatory documentation are produced in support of on-going development programs.   The ideal candidate will have shown proficiency in both knowledge and ability to manage and solve CMC challenges in a highly regulated pharmaceutical environment.   The position requires a strong background in Process or Chemistry as the ideal candidate will be asked to develop and execute scientific strategies at external vendors, as well author/review documents for regulatory and patent purposes.  Large scale manufacturing experience required.  Preference will be given to candidates who have demonstrated excellent lab skills and the capability to problem-solve CMC challenges proficiently via sound experimental design. 

Responsibilities will include but are not limited to the following:

  • Generate technical packages and transfer to external contract manufacturers.  Manage project activities and timelines; organize and participate in cross-functional teams.
  • Generate, maintain and review drug development and CMC documents, vendor documents, manufacturing and batch records, and other study related documents.  
  • Liaison with vendor and/or CRO regarding project activities and deliverables
  • Generate and manage work plans
  • Participate in vendor trouble-shooting efforts.
  • Generate and/or review pertinent SOP and guidance documents pertaining to management and execution of CMC activities. Generation and review of regulatory filing materials for trials both in the US and abroad.
  • Support Quality Assurance to maintain and ensure high quality of documents in compliance with GMP
  • Perform evaluations, technical audits and site visits of vendors.  Work with Quality Assurance to support quality audits and establish quality agreements.
  • Work with Legal and Finance to generate MSAs, CDAs, and project orders in support of CMC projects.
  • Support the filing of CMC related patents.
  • Participate on cross-functional development teams.

Requirements

  • Ph.D. in Organic Chemistry with 5 years of pharmaceutical experience or MS Degree with 10 years pharmaceutical experience for Senior Scientist
  • Ph D in  in Organic Chemistry with 8 years of pharmaceutical experience or MS Degree with 15 years pharmaceutical experience for Principal Scientist

The following are preferred

  • Organic chemists with large scale process chemistry experience
  • Good understanding of analytical chemistry a plus
  • Excellent experience trouble-shooting issues at vendors responsible for cGMP manufacturing.
  • Good working knowledge of GMP and regulatory requirements.
  • Excellent interpersonal skills, with a demonstrated ability to work in a team environment.
  • Additional attributes include an ability to multi-task, be flexible, and to thrive in a fast-paced environment.
  • Excellent oral and written skills
  • CMC Regulatory Writing/Review experience a plus
  • Must be able to travel upon occasion to vendor and contract manufacturer sites

 NO AGENCIES, PLEASE

Associate Director – Epigenetics

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Associate Director – Epigenetics

RaNA Therapeutics is an energetic, rapidly growing early stage biotechnology company in Cambridge, MA founded by leading scientists from industry and Massachusetts General Hospital. RaNA’s mission is to discover and develop drugs to improve health for patients by modulating disease-associated epigenetic patterns, thereby restoring normal expression of individual targeted genes.

We are currently seeking a highly motivated and results-oriented Associate Director to join RaNA and lead a team of skilled epigenetic scientists.  Reporting to the Director of Biology, you will be responsible for determining the mechanism of action of RaNA compounds, building new lncRNA transcriptomes, contributing to RaNA’s IP portfolio, planning and execution within various RaNA timelines, as well as managing certain academic collaborations/publication efforts. Responsibilities will include, but not be limited to novel epigenetic assay development, target validation, identification of project risks and contingency planning while leveraging primary technical expertise in the area of epigenetics. Candidate will be responsible for developing novel transcriptomes from primary cell lines and tissues, collaborating with the bioinformatics group to jointly manage our NGS efforts and managing the group’s time and resources to ensure successful outcome against specific goals.

Qualifications:

  • The candidate must have a PhD in cell biology, biochemistry, molecular biology or a related area with a strong focus in epigenetics. A solid understanding and demonstrated achievements in applying epigenetic assays for drug screening is required.

 

  • Experience in epigenetic research, cellular functional studies and biochemical assays are essential.

 

  • Experience of developing novel assays and multi-parametric statistical data analysis is essential.

 

  • The candidate will have at least 6 years of practical experience in a laboratory environment.  Ideally this will have been gained within a pharmaceutical organization. 

 

  • A track record of successfully applying these skills to better understand the pathophysiology of disease and the action of drug-like molecules on cells/tissues is essential.

 

  • Ability to multitask and work independently and collaboratively as part of an interdisciplinary team in a matrix environment with 15-20 scientists. Excellent organizational and time management skills, the ability to generate high quality data analysis results under tight deadlines.

 

  • Supervisory experience is necessary as the group will expand over time

 

  • Ability to interact well across the organization and with external collaborators.

 

 

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S. RaNA employee benefits package include health/dental insurance, retirement plan, and more.

Senior Scientist/Assoc Director – In vitro drug discovery

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Senior Scientist/Associate Director – In vitro Drug Discovery

RaNA Therapeutics is an energetic, rapidly growing early stage biotechnology company in Cambridge, MA founded by leading scientists from industry and Massachusetts General Hospital. RaNA’s mission is to discover and develop drugs to improve health for patients by modulating disease-associated epigenetic patterns, thereby restoring normal expression of individual targeted genes.

We are currently seeking a highly motivated and results-oriented Senior Scientist/Associate Director to join RaNA.  Reporting to the Director of Biology, this position will be responsible for in vitro oligonucleotide screening, planning and execution within various RaNA timelines, as well as managing certain academic collaborations/publication efforts. Responsibilities will include, but not be limited to target identification, assay development, target validation, identification of project risks and contingency planning while leveraging primary technical expertise in the area of cell/tissue based assays. Candidate will be responsible for developing functional assays from cell lines and tissue samples and for managing time and resources to ensure successful outcome against specific goals.

Qualifications:

  • The candidate must have a PhD in cell biology, biochemistry or a related area. A solid understanding and demonstrated achievements in applying cell/tissue based assays using oligonucleotides/siRNA for drug screening is required.

 

  • Experience in cell culture, qRT-PCR, siRNA and miRNA research, cellular functional studies, biochemical assays, virology and molecular biology techniques are essential.

 

  • Experience of developing novel assays and multi-parametric statistical data analysis is essential.

 

  • The candidate will have at least 6 years of practical experience in a laboratory environment.  Ideally this will have been gained within a pharmaceutical organization. 

 

  • A track record of successfully applying these skills to better understand the pathophysiology of disease and the action of drug-like molecules on cells/tissues is essential.

 

  • Ability to multitask and work independently and collaboratively as part of an interdisciplinary team in a matrix environment with 15-20 scientists. Excellent organizational and time management skills, the ability to generate high quality data analysis results under tight deadlines.

 

  • Supervisory experience is necessary as the group will expand over time

 

  • Ability to interact well across the organization and with external collaborators.

 

 

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S. RaNA employee benefits package include health/dental insurance, retirement plan, and more.

Project Manager – Breeding Services

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There is a regular, full-time Project Manager position available in Breeding Services at The Jackson Laboratory in Bar Harbor, Maine.

This position offers a dynamic work environment where a close relationship is formed with multiple investigators to support their ongoing cutting edge research.   The project manager has opportunity to learn about wide ranging topics in mouse research, and have great influence over the success of important scientific studies.

The Project Manager works with investigators to define the project scope, goals and deliverables for contract breeding services.  The Project Manager will be responsible for preparing quotations, overall project coordination, execution and completion.  An in-depth understanding of genetics and mouse biology, a customer centric focus, excellent communication skills, and proficiency with available project tracking and communication tools are essential to success in this position.

Qualifications include:

  • A bachelor’s degree in biological science (or equivalent years of relevant experience).  Master’s degree is preferred. 
  • Knowledge of college level Mendelian genetics that can be obtained through a genetics course at an accredited college or university is preferred.
  • Knowledge of animal husbandry and colony management as acquired by attainment of a Baccalaureate degree in animal science /BS in a life science or three – five years experience in a position in which knowledge of animal husbandry and colony management played a large role in job responsibilities.
  • Excellent customer service to understand and react to the needs of the investigators.
  • Strong proficiency with a variety of software tools including Word, Excel, and Microsoft based database systems.
  • Superior organizational skills and attention to detail necessary to maintain project records and production of animals as scheduled.
  • Exceptional verbal and written communication skills.  Must be about to establish effective two-way communication with investigators and department heads regarding scientific needs and deadlines.
  • Ability to effectively negotiate with customers and JAX staff to meet project goals and to ensure customer satisfaction.
  • Dedication to project success in a fast-paced scientific and business driven environment.

This position offers opportunities for advancement, and fulfilling interactions both with internal and external groups.

All interested individuals should apply on-line at www.jax.org/careers, referring to job requisition #3562 by submitting a cover letter and resume as one document by copy & pasting or uploading. 

LIMS Software Engineer

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Are you familiar with the processes and procedures of a scientific laboratory? Do you have solid experience with .Net development in an agile environment? How would you like to work with a close-knit team that is implementing a enterprise Laboratory Information Management System in an organization working to discover precise genomic solutions for disease and empower the global biomedical community in our shared quest to improve human health?

 

If so, The Jackson Laboratory has a great opportunity for you in beautiful Down East Maine or potentially in a remote/telecommute environment. We are seeking Software Engineers with solid experience in .Net development and Laboratory Information Management Systems to contribute in a team-oriented environment to a multi-year implementation of an enterprise LIMS system across several dozen laboratories at multiple sites in the organization.  Successful candidates will work closely with laboratory personnel and the LIMS implementation team to configure user interfaces, process and workflow, provide data management, and develop systems integrations to meet the rapidly growing and highly integrated needs of laboratory service groups.

 

Responsibilities:

  • Participate in requirements development
  • Lead design and code development and review
  • Create, test, maintain and troubleshoot software
  • Author application and system design, implementation, and operation documentation
  • Becomes highly proficient in commercial enterprise LIMS software systems

 Qualifications/Skills

  • A bachelor's degree or greater in Computer Science or related field
  • 5-10 years of experience in object-oriented, n-tier application, and Web Services software development, including .Net, C# and related technologies, SQL, Jscript, VB Script, Visual Studio, and industry standard design patterns
  • Expertise with relational database design and programming (Oracle, SQLServer, MySQL) 
  • Experience with scientific lab automation and data and instrument integration
  • Experience with SDLC, multiple environment release management, and Team Foundation Server
  • Ability to work closely with laboratory users to advise/recommend functional optimizations and solutions
  • Able to cope with many different projects and initiatives simultaneously, and to deliver under pressure
  • Excellent written and verbal communication skills (both technical and functional)
  • Experience with STARLiMS preferred
  • Experience with GxP/CLIA preferred

 Benefits:

  • Contribute to cutting edge research and technology in a non-profit organization with a rewarding humanitarian mission
  • Enjoy a competitive compensation and benefits package
  • Work with the best technical and scientific staff in the field
  • Be part of an active, diverse community with an active health and wellness program, including an onsite fitness facility
  • Close proximity to the Northeast's greatest natural treasure – Acadia National Park and the beautiful Down East shoreline and waters

 Interested individuals should apply on-line at www.jax.org/Careers referring to job requisition #3564. 

Clinical Trial Manager

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Duties:

Negotiate and finalize clinical trial agreements, contract research organizations (CROs) agreements, general service agreements, consultancy agreements, and lab services. Identifies potential vendors and negotiates budgets. Collaborates with clinical trial team, study start up groups, Investigational sites and vendors to verify and develop budget and negotiated cost savings. Works closely with clinical trial team and study start up teams to ensure delivery of fully executed contracts in support of timely study start-up to meet departmental and organizational goals.

Requirements:

  • BS/MS with at least 5 years experience at a pharmaceutical company or CRO
  • Minimum of 3 years experience in contract negotiation and preparation and familiarity with legal terminology associated with the pharmaceutical industry.
  • Experience with the negotiation of contract terms, pricing, payment schedules, Confidentiality Agreements (CDAs), generation of the final contract, and management of ongoing vendor collaborations

 

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


Associate Director, JAX Services Business Development/Sr. Manager, JAX Services Business – NY/CT Territory

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There is a regular, full-time Services Business Development Manager position available to cover the states of New York and Connecticut and the Canadian Province of Ontario.  This role has the overall responsibility of ensuring revenue and management objectives are met and exceeded for the assigned area with an emphasis on bringing the value of the science of JAX as solutions to customers.  The incumbent will develop winning project proposals that involve multiple operational units and works closely with Business Unit Managers and JAX Mice and Services Sr. Managers to develop value propositions and incentives to support the acceptance of contracts aimed at increasing revenues and strengthening customer relationships. This dynamic role will develop and maintain strong customer relationships and provide consultative solutions and required customer support. 

Responsibilities include:

  • Providing regular, direct, personal contact to present and prospective customers
  • Providing consultative, problem solving services customers – with an understanding of customer needs and possible JAX solutions.
  • Developing a strong understanding of our overall customer organization structure, building relationships (establish credibility and rapport) throughout the scientific and executive levels of our customer base as well as in critical gate-keeping functions.
  • Working in a collaborative manner with a variety of internal teams throughout the organization to meet or exceed the financial goal(s) for highly complex services delivered by JAX.
  • Working closely with Business Unit Manager(s) to integrate agreement terms into customer workflow for JAX Mice and Services offerings. 
  • Actively participating in relevant committees and procurement subgroups to raise awareness of The Jackson Laboratory and increase influence of JAX Mice and Services.
  • Mentoring Opportunity Development Managers including  coaching and guidance in customizing specialized customer projects/plans and  maximizing territory penetration
  • Developing strategies to increase number of and magnitude of projects in excess of $30,000 on an ongoing/annual basis.
  • Providing solutions that create long standing relationships by addressing the unique needs of our customers.

 Required Skills

  • Excellent leadership and interpersonal skills.  Highly developed verbal and written communication skills.
  • The ability to build strong relationships across the organization and thrive in a culture that values diversity of thought
  • Strong analytical skills.
  • Strong consultative selling skills and proven capability to close sales. 
  • Consistently exceed goals.
  • Excellent business management skills—business acumen, organization, planning, budgeting, setting goals and objectives.
  • Ability to travel up to 60%.
  • Must possess valid driver’s license and the ability to safely operate a motor vehicle.

Required Experience

  • BS/BA required (preferable in Life or Animal Sciences), MS/MBA and/or Ph.D. preferred.
  • Associate Director; preceding requirement in addition to 5 years or more of direct business development in biomedical or animal science sales including documented, successful field territory management, strategic account development and a demonstrated ability to mentor peers and/or team.

To be considered for this position, please submit a cover letter and resume by uploading or copy & pasting as one document to www.jax.org/careers Requisition 3552.

 

Brand Lead

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Merrimack is creating a new division, Merrimack Healthcare Solutions (MHS), with the goal of implementing a novel, more effective approach to the commercialization of pharmaceuticals that is different from the traditional “playbooks” that have been used to date.  MHS is responsible for working with customers and partners to ensure the successful launch and rapid adoption of MM-398 and the rest of Merrimack’s future therapeutic and diagnostic products.  We are looking for experienced, innovative individuals who want to explore novel ways to commercialize Merrimack’s therapeutic and diagnostic products in tomorrow’s dynamic healthcare environment.

We are seeking an individual to be responsible for successfully guiding the pre-launch preparation and market launch of MM-398. The individual in this position will interact on a day-to-day basis with other leaders within MHS as well as the late-stage development team and senior management to ensure that the marketing and brand strategy for MM-398 is developed and implemented successfully.

Job Responsibilities

  • Leading the development and implementation of the overall brand strategy and objectives, including driving product positioning and competitive strategies
  • Translating clinical, scientific and market research data and insights into a coherent and compelling messaging platform for customers/stakeholders
  • Leading a cross-functional team to ensure launch readiness across all functional areas
  • Developing and monitoring of key performance metrics for the brand
  • Developing strong relationships with key opinion leaders, physician advisory board members and patient advocacy groups
  • Representing the commercial perspective in clinical development activities with the late-stage development team(s)
  • Hiring, managing and developing key team members
  • Leading the development and implementation of the overall brand strategy and objectives, including driving product positioning and competitive strategies
  • Translating clinical, scientific and market research data and insights into a coherent and compelling messaging platform for customers/stakeholders
  • Leading a cross-functional team to ensure launch readiness across all functional areas
  • Developing and monitoring of key performance metrics for the brand
  • Developing strong relationships with key opinion leaders, physician advisory board members and patient advocacy groups
  • Representing the commercial perspective in clinical development activities with the late-stage development team(s)
  • Hiring, managing and developing key team members

Requirements

  • 10+ years of commercial and marketing experience in the pharmaceutical or biotechnology industry, particularly in oncology
  • Pre-launch and launch experience
  • Global marketing experience desirable, but not essential
  • Creative, strategic thinking with proven success applying analytical approaches to business problem solving as well as turning data and/or qualitative insights into actionable recommendations and solutions
  • Proven ability to lead and manage interdisciplinary teams in a dynamic, cross-functional environment
  • Strong leadership and influencing skills
  • Experience managing and mentoring multiple team members
  • Excellent written and verbal communication skills
  • Passion for fighting cancer

Field Lead

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Merrimack is creating a new division, Merrimack Healthcare Solutions (MHS), with the goal of implementing a novel, more effective approach to the commercialization of pharmaceuticals that is different form the traditional “playbook” used by large biopharmaceutical organizations.  MHS is responsible for working with customers and partners to ensure the successful launch and rapid adoption of MM-398 and the rest of Merrimack’s future therapeutic and diagnostic products.  We are looking for experienced, innovative individuals who want to explore novel ways to commercialize Merrimack’s therapeutic and diagnostic products in tomorrow’s dynamic healthcare environment.
 
We are looking for an experienced and creative individual to be responsible for designing, developing and implementing the optimal field force model for Merrimack and scaling up the field team appropriately over time. The individual in this position will interact on a day-to-day basis with other leaders within MHS as well as the late-stage development team and senior management to ensure that the field force is trained successfully and deployed optimally to provide effective support and education to potential MM-398 customers.
 
Job Responsibilities

  • Identifying the optimal manner by which to engage with and provide support to physicians, other healthcare providers and related stakeholders
  • Generating creative models for field force engagement with stakeholders and conducting research to test potential alternatives
  • Recommending and obtaining internal buy-in for the optimal MHS field force strategy and implementing the appropriate model
  • Ensure that strategies, objectives and tactics for the brand are accurately translated to the field
  • Hiring key field force leaders and overseeing the execution of the field force hiring plan as MM-398 progresses towards launch
  • Identifying training needs and developing and supporting field force training programs
  • Leading the definition of the scale and scope of training and enabling operations teams

Requirements

  • 10+ years in sales/field management role in biotech or pharma, particularly in the oncology area
  • Pre-launch and launch experience
  • Experience hiring and managing sales/field force representatives
  • Creative, strategic thinking with proven success applying analytical approaches to business problem solving as well as turning data and/or qualitative insights into actionable recommendations and solutions
  • Proven ability to lead and manage interdisciplinary teams in a dynamic, cross-functional environment
  • Strong leadership and influencing skills
  • Experience managing and mentoring multiple team members
  • Excellent written and verbal communication skills
  • Passion for fighting cancer

Clinical Trials Manager

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Clinical Trials Manager  

Overview:

The Clinical Trials Manager works closely with internal team members and vendors to ensure that assigned clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and budgets.

 

Position Responsibilities:

  • Comprehensive oversight of operational aspects of assigned clinical trials
  • Management of CRO interactions, including sponsor oversight of relevant functional activities (e.g., study management, monitoring, site management, and project master files)
  • Monitoring of study progress: ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors including CRAs as applicable; completing sponsor's review of monitoring reports and periodic review of data quality; identifying potential study issues and recommending and implementing solutions or corrective actions as needed
  • Serving as a liaison and resource for investigational sites: reviewing investigator contracts and site payments
  • Occasionally traveling to CRO/vendor facilities and/or investigator sites to train and access study team and CRAs
  • Organizing and managing internal team meetings and other trial-specific meetings
  • Participating in the development, review and implementation of departmental SOPs and processes
  • Other job related duties as assigned
  • Phase I Clinical Trials experience
  • Pediatric experience a plus

 

Job Requirements:

  • Excellent oral and written communications skills
  • Strong computer skills (Microsoft EXCEL, WORD and OUTLOOK)
  • Ability to work in a fast paced environment
  • Excellent organizational and management skills
  • Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact
  • Experience with Phase I Clinical Trials
  • Pediatric experience a plus

 

Education/Experience:

  • BS/BA degree in Science or similar area
  • 4-6 years experience managing clinical trials for or within the Biotech/Pharmaceutical industry including CRO/vendor management, monitoring budget scope, clinical site monitoring and knowledge of basic data management/biostatistics
  • Prior Oncology experience desired, but not required
  • In-depth knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines required

 

Project Manager

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ImmunoGen, Inc. is in search of an organized and motivated team player to join our Program Management department.  The Project Manager will work with the Project Leader to execute high quality, integrated cross-functional plans for Research and Development Programs.  Together with the Project Leader, the Project Manager will execute strategy for a drug development program through a cross functional team and facilitate information exchange between team members, identify and resolve project related issues, manage to timelines and communicate progress/issues arising on the project.

Responsibilities:

  • Co-manages a cross-functional project team to ensure development and execution of project plans, alignment of project goals with stated corporate strategy and objectives.
  • Develops tools and mechanisms for monitoring project progress, intervention and problem solving within project team and line managers
  • Drives implementation and management of day-to-day project management procedures: specific communication tools that enhance information exchange; department metrics reporting; project management files/databases
  • Manages the development and execution of project development plans, timelines and budgets
  • Liaises with functional areas responsible for the project and provides guidance on resolving program challenges
  • Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people
  • Facilitates meetings, produce minutes and follow up action items
  • Creates, manages and tracks project timeline and other appropriate metrics
  • Creates, edits and presents project updates as needed
  • Prepares regular status reports and presentations

 Qualifications:

  • 3-5 years of related industry experience
  • 1-3 years of project management experience
  • Minimum BS in a scientific discipline. Advanced degree preferred.
  • Experience with antibodies or biologics preferred
  • Knowledge of team dynamics, structure, roles and responsibilities
  • Demonstrated people management skills
  • Strong influence and interpersonal skills       
  • Excellent meeting management skills
  • Excellent  verbal, written and presentation skills
  • Proficiency with Microsoft Office software

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:  Human Resources Department, ImmunoGen, Inc., 830 Winter Street, Waltham, MA 02451: Fax: 781-895-0611; E-mail: resumes@immunogen.com.  Please reference the ad source in your response.

 We are an Equal Opportunity Employer

 

Associate Computational Biologist

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The Broad Institute of MIT & Harvard is looking to hire an exceptional candidate to join an initiative whose goal is to translate cutting-edge genomics into novel therapeutics. The successful candidate will join an interdisciplinary team of computational biologists, genome biologists and clinicians who are working together to understand how genes that normally protects us, can turn our immune system against us. Gaining such an understanding will allow us to identify therapeutic leads that can subvert autoimmune and inflammatory processes and potentially help diabetic patients, for example.

We are looking for individuals who are enthusiastic about taking a hands-on, problem-solving approach, and collaborating with engineers and scientists in a collegial environment that is infused with intellectual rigor. The successful candidate will be an innovative and analytical thinker, and will enjoy working in an interdisciplinary team.The Broad Institute provides a vibrant research environment with close links to MIT, Harvard and the Harvard-affiliated hospitals across Boston. Being a member of our initiative will provide the opportunity for your contributions to be utilized and recognized across the vast global network of researchers in the fields of genomics and chemical biology.

Characteristic Duties:
- Develop data analysis strategies, write algorithms, and deploy computational tools for the exploration of large data sets.
- Conceive, implement and test statistical models; work with wet-lab researchers to translate these models into testable experiments; analyze the data produced from these experiments.
- Explore novel data visualization and text-mining tools with an emphasis on integrating diverse data types.
- Implement algorithms and develop software for application in disease pathway discovery.
- B.S in Computer Science, Engineering, Math, Statistics, Physics, or a related quantitative discipline
- Practical experience with programming languages Java and C; and analytical programs MATLAB, R, or Python
- Experience with computational analysis, algorithm development and statisticsA background in biology is not required, though an interest in applying one’s analytical and programming skills to developing research tools is necessary.

If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=1727249-2605-4880

Senior Software Engineer

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The Chemical Biology Platform is comprised of scientists and engineers from a wide range of disciplines, working cooperatively to empower researchers in the discovery of small-molecule probes (used to understand cell circuitry and disease biology) and small-molecule therapeutics (used to treat disease). The Discovery Informatics team builds and maintains software, tools and processes for automated high-throughput screening and small molecule synthesis. We enable the discovery process by providing the Lab Information Management Systems (LIMS) and Data Analysis tools required to support the end-to-end process.

The functional areas include Synthetic, Analytical and Medicinal Chemistry, Screening, Automation and Compound Management.If you have the desire to solve seemingly impossible problems and to work on large-scale, complex projects in an interactive team environment, then we need you on our team.Under the direction of the Group Leader, Discovery Informatics, the Senior Software Engineer will enhance and maintain the software used by scientists in the Chemical Biology Platform. They will partner with Application Engineers and/or scientists to determine the scope and requirements of new feature requests. This person is expected to design and implement solutions to complex technical problems with minimal supervision. On larger software development efforts, they will take ownership of entire modules/subsystems. They will also mentor more junior engineers in best practices.

KEY RESPONSIBILITIES / ESSENTIAL FUNCTIONS
• Design and implement software solutions for Discovery Informatics
• Define technical requirements and write design specifications to meet these requirements
• Gather and document business requirements for feature requests
• Mentor junior engineers in best practices
• Required: Bachelor's degree in Computer Science or related field
• 5+ years of software development experience
• Demonstrated knowledge of any combination of the following languages required: Java, Groovy, C++ required. Must have expert level knowledge in at least one of these languages.
• Experience working with Oracle, designing relational schemas, and writing SQL
• Knowledge of data warehousing (star/snowflake schema design, OLAP, ETL) a strong plus
• Experience with agile development practices, such as test-driven development and pair programming, a strong plus.
• Prior involvement or interest in biology, genomics, or chemistry domain a plus.
• Excellent communication skills and the ability to perform effectively in a fast paced environment required.
• Must be able to handle a variety of tasks, effectively solve problems with numerous and complex variables, and be able to shift priorities rapidly.

If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=1727270-2605-6980


Sr. Director, ICSR

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The Senior Director will have high visibility across R&D and reports directly to the Vice President of Global Patient Safety. He/she is responsible for managing the line function at a technical and strategic level.  The Senior Director will play a major role in shaping cohesive pharmacovigilance strategies through effective optimization and integration of all groups within their area of responsibility.

Responsibilities include the maintenance of structural organization within the Department, as well as the technical and managerial coordination of its groups and staff. Additionally, the Sr. Director will have full support from the other functions within Global Patient Safety as well the ability to work cross functionally with other areas in the organization

Key Responsibilities  
- Oversees development and implementation of standard processes and procedures in handling individual case safety reports and assuring compliance with global and local regulatory requirements
- Strategic and tactical clinical trial support to enable compliance in safety reporting  in clinical trials
- Collaborates with GPS Quality, Standards & Training in identification and remediation in continuous improvement activities
- Collaborates with the Operations group to ensure quality inputs and outputs of the safety database
- Collaborates with the Sr. Director of Medical Operations to ensure consistent standards and quality of ICSRs
- Serve as functional  lead in collaboration with key internal and external stakeholders
- Effective management of resources, vendors, business partners, and CROs
- Manages personnel performance and develops career growth opportunities across the department
- Provides expert guidance and leadership, internally and externally
- Responsible in maintaining quality, standards and  training of personnel
- Responsible in ensuring the most effective utilization of the safety database to support safety reporting, audits and inspections
- Anticipates regulatory changes and develops contingency plans accordingly
- Represents GPS function on Vertex Corporate teams

Minimum Qualifications
- Bachelor degree in life sciences or allied health fields required; 5+ years of direct Pharmacovigilance experience
- Solid knowledge of safety database operations and function
- Strong knowledge of Global Regulations, standards and best practices regarding safety processing and reporting, safety surveillance and pharmaceutical industry compliance activities in pre-marketing and post-marketing
- Strong operational skills as demonstrated by leading previous projects or functions and or equivalent in training and education in areas such as lean sigma or MBA
- Experience as a line manager or people manager

Preferred Qualifications
- M.D. or Masters /Doctorate level in life sciences or allied health fields, 5+ years of direct Pharmacovigilance experience
- Excellent verbal and written communication skills.
- Self-starter with proven ability to thrive in a fast-paced environment handling multiple simultaneous high priority tasks
- Successful track record of developing and mentoring staff
- Maintains high ethical standards, including a commitment to Vertex's values and behaviors

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

Project Assistant

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Project Assistant

Toxikon Corporation, originally founded in 1977, is a Contract Research and testing company with laboratories in Bedford, MA and Belgium. Our mission continues to focus on providing quality services, competitively priced, with on-time delivery for the Pharmaceutical, Medical Device and Biotech industries.

Toxikon is seeking a Project Assistant who will aid in the management of projects within Toxikon’s portfolio of biocompatibility, pharmacology/toxicology, and efficacy services. The responsibilities include working with the Project Coordinator and Program Manager for reporting of project timelines, tracking the flow of projects through multiple departments, identifying roadblocks in the process, creative problem-solving, coordinating resources, and ensuring that the project proceeds on time and within budget. This person must possess good communication skills in order to communicate effectively to sponsors, sales, study directors, and staff within multiple departments. A high level of organization and initiative is required to accommodate multiple demands and shifting priorities.

Qualified candidates should have an associate’s or bachelor’s degree (Life Sciences discipline preferred) and have good communication and computer skills. Knowledge of project management processes is considered a plus.

For additional information about Toxikon, please view our website at www.toxikon.com

Submit resumes and Salary requirements:

Human Resources

Toxikon Corporation

15 Wiggins Avenue

Bedford, MA 01730

Email: hr@toxikon.com

Toxikon employs 160 people and offers a generous benefit program including health, dental, fsa, std, ltd, life insurance and matching 401K plan. Toxikon is an EOE.

Associate Director, Accounting and Collaboration

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Position description:

This position requires a highly motivated, detail and service orientated individual to be responsible for managing the worldwide collaboration accounting at Ironwood.

The Company’s lead product, that was approved for marketing in the US and Europe in 2012. Our product is being commercialized in the US by Ironwood and its collaboration partners and the parties share equally the net profits and net losses from this arrangement. US net sales are calculated by our partner and reported to the Company on a regular basis. In Europe, the product is being marketed by our collaboration partner. The Company will receive escalating royalties from the sales of our product in the European territory. In addition, the Company’s partners for Japan and China, continue to develop our product in their territories. In addition to the above four partnerships around the Company’s lead compound, Ironwood has formed in-licensing relationships with Bionomics, Depomed and Protagonist. This position will be responsible for overseeing the above collaborations.

 

This position reports to the Director of Accounting Policy and External Reporting.

 

Responsibilities:

  • Liaise with various internal departments as well as external collaboration partners on the implementation of processes and procedures for accurate and timely collaboration revenue and expense recognition
  • Analyze and understand various collaboration, in-licensing and out-licensing arrangements and related revenue/expense streams to ensure proper P&L recognition and financial system set-up
  • Partner with the Company’s commercial team and external collaboration partners to assess market conditions and trends for linaclotide and to evaluate the reasonableness of the related revenue assumptions developed by our collaboration partners
  • Assess the economics and profitability of each collaboration on a regular basis and present the results to senior management
  • Prepare periodic P&L reports for each collaboration which include variance analysis of collaboration revenue accounts and associated expense accounts against prior periods and budget
  • Provide insight to collaboration revenue and expense forecasting to facilitate the Company’s ability to execute operational goals and objectives
  • Maintain compliance with all collaboration contracts and conduct audits of the collaboration arrangements, as necessary
  • Complete periodic assessments to identify variable interest entities (“VIE”) and understand the Company’s requirements to consolidate such VIEs
  • Deliver the highest standard of departmental, cross departmental and collaboration partner customer service
  • Develop collaboration revenue controls and assist in the automation of those controls
  • Responsible for SOX compliance for collaboration revenue accounting related controls by continuously working to align them to the collaboration revenue risk profile, lead changes, maintain required documentation and coordinate the testing of the collaboration revenue cycle;
  • Support various special projects as required.
  • 8-10 years of relevant work experience and CPA is required;
  • Solid understanding and experience dealing with collaboration accounting and gross-to-net revenue recognition requirements under US GAAP, such as ASC 605-25 “Multiple-Element Arrangements”, ASC 605-28 “Milestone Method”, ASC 605-45 “Principal Agent Considerations”, SAB 104 “Revenue Recognition”, and other pertinent authoritative literature.
  • Solid understanding and experience with ASC 810 “Consolidation” and ASC 808 “Collaborative Arrangements”
  • Ability to effectively use accounting knowledge to work closely with collaboration partners, varying levels of employees and senior management to manage the Company’s world-wide collaboration accounting;
  • Ability to build strong relationships with new and existing collaboration partners;
  • Ability to quickly grasp company operations and business drivers;
  • Detailed oriented while maintaining adequate perspective of how the collaboration-related transactions fit into the Company’s overall profile and financial statements disclosure requirements.
  • Ability to prioritize actions and manage multiple deadlines.
  • Experience working with life science or pharmaceutical companies as well as a “Big 4” accounting firm strongly preferred;
  • Individual must have very strong communication and analytical skills;
  • Individual must have strong organizational skills and be able to work in a fast-paced dynamic team environment.

Requirements:

 

  • 8-10 years of relevant work experience and CPA is required;
  • Solid understanding and experience dealing with collaboration accounting and gross-to-net revenue recognition requirements under US GAAP, such as ASC 605-25 “Multiple-Element Arrangements”, ASC 605-28 “Milestone Method”, ASC 605-45 “Principal Agent Considerations”, SAB 104 “Revenue Recognition”, and other pertinent authoritative literature.
  • Solid understanding and experience with ASC 810 “Consolidation” and ASC 808 “Collaborative Arrangements”
  • Ability to effectively use accounting knowledge to work closely with collaboration partners, varying levels of employees and senior management to manage the Company’s world-wide collaboration accounting;
  • Ability to build strong relationships with new and existing collaboration partners;
  • Ability to quickly grasp company operations and business drivers;
  • Detailed oriented while maintaining adequate perspective of how the collaboration-related transactions fit into the Company’s overall profile and financial statements disclosure requirements.
  • Ability to prioritize actions and manage multiple deadlines.
  • Experience working with life science or pharmaceutical companies as well as a “Big 4” accounting firm strongly preferred;
  • Individual must have very strong communication and analytical skills;
  • Individual must have strong organizational skills and be able to work in a fast-paced dynamic team environment.

Bioinformatics Software Engineer

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Our client is seeking a talented and highly motivated Software Engineer to develop, optimize, and implement data analysis pipelines and analytical tools into discovering proteomic drug targets.  In this position you would be required to work independently preparing timelines, deliverables and project schedules as well as presenting technical progress.  This position requires a BS in computer science or related discipline with a minimum of three years life science industry experience.  This position requires expert knowledge in Java/C++ and of Python/Perl, a strong statistical analysis background including R, as well as experience in database design/implementation, web client applications, Unix, agile SW development.

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.

Associate Dir/Director Clinical Science

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Associate Director/Director Clinical Science

 

The Associate Director/Director position is responsible for contributing to clinical science activities and providing medical support to clinical operations.  The position will help to generate clinical development plans and provide medical and scientific input for Celldex sponsored and investigator initiated protocols. As a medical monitor, the position will oversee study patient safety, play key roles in data collection, data cleaning, and data analysis, train internal and study site staffs on study procedures, and address study related medical and protocol issues. There are potential additional opportunities in managing collaborations with partners and in regulatory communications.

 

Position Responsibilities:

  • Assist in preparation of clinical development plans and clinical protocols.
  • Providing medical input to clinical operations, regulatory and preclinical programs.
  • Medical monitor with oversight of patient safety.
  • Training and collaboration with staff within the areas of responsibility.
  • Performs other additional job related duties as required.

 

Required Skills:

  • The ability to function on an even scientific and clinical level with investigators and experts
  • The ability to be a “team-player”
  • Excellent oral and written communication skills.
  • Excellent interpersonal and organizational skills and attention to details.

 

Education/Experience:

  • MD, with specialization in immunologic related field or internal medicine, (oncology, rheumatology, infectious disease or hematology a plus).
  • Experience in clinical research, including designing, planning and monitoring clinical trials.
  • Experience in Biotech and or Pharma (1-2 years minimum) or experience as academic clinical investigator.

 

 

 

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