Are you the publisher? Claim or contact us about this channel


Embed this content in your HTML

Search

Report adult content:

click to rate:

Account: (login)

More Channels


Showcase


Channel Catalog


Channel Description:

Career postings for the Massachusetts Biotechnology Council

older | 1 | .... | 841 | 842 | (Page 843) | 844 | 845 | .... | 855 | newer

    0 0

    ***Please send your resume and interest in this position via e-mail***

    The Controlled Substances Specialist participates in the tracking of and maintaining the controlled substances program, policies, and procedures under the guidance of the Head of Operational Compliance, ICQM. Specialist is responsible for day to day material maintenance and providing technical guidance and training to researchers who handle controlled substances and monitoring their compliance with the program.

    Major Accountabilities:

    • Assist researchers in determining their needs (drugs, questions with formulations, ordering, receiving, dispensing, disposing) and resolve or escalate any issues related to controlled substance materials
    • Perform periodic inspections based on defined specifications of laboratory spaces using controlled substances and assist with disposal of controlled substances
    • Track & maintain a controlled substances inventory for site. Additionally, ensure that all movements of chemical compounds comply with procedures and guidelines.  This includes using proprietary databases and software tools, and documentation of all requests.
    • Provides monthly reporting on performance measures and statistics; conduct audit checks of the controlled substances program
    • Track all reporting requirements of the DEA including requests for controlled substance quota, completion of reports for theft or loss, and destruction reports
    • Conduct defined training sessions with researchers responsible for direct handling of controlled substances in order to ensure their understanding of DEA requirements

    REQUIREMENTS:


    Education:

    • Bachelor’s degree in sciences with a minimum of 2 years of relevant science experience in Chemistry, Medicinal Chemistry, or related field preferred. 

    Languages:

    • English (written and spoken), other languages such as German and French would be advantageous
    • Experience/Skills:
    • Experience in a Pharmaceutical or Biotech company a plus
    • Comfort with tools and sites such as ChemDraw, JChem, SciFinder and related tool
    • Working knowledge or willingness to learn DEA and MDPH regulations regarding the handling of controlled substances is required
    • The individual must understand “customer focus” and be professional within workplace
    • Individual must be self-motivated, well-organized, reliable, and able to prioritize workload
    • Ability to work independently with some supervision
    • Good communication skills, collaboration, and follow through

     


    0 0

    ***Please send your resume and interest in this position via e-mail***

    The Controlled Substances Specialist participates in the tracking of and maintaining the controlled substances program, policies, and procedures under the guidance of the Head of Operational Compliance, ICQM. Specialist is responsible for day to day material maintenance and providing technical guidance and training to researchers who handle controlled substances and monitoring their compliance with the program.

    Major Accountabilities:

    • Assist researchers in determining their needs (drugs, questions with formulations, ordering, receiving, dispensing, disposing) and resolve or escalate any issues related to controlled substance materials
    • Perform periodic inspections based on defined specifications of laboratory spaces using controlled substances and assist with disposal of controlled substances
    • Track & maintain a controlled substances inventory for site. Additionally, ensure that all movements of chemical compounds comply with procedures and guidelines.  This includes using proprietary databases and software tools, and documentation of all requests.
    • Provides monthly reporting on performance measures and statistics; conduct audit checks of the controlled substances program
    • Track all reporting requirements of the DEA including requests for controlled substance quota, completion of reports for theft or loss, and destruction reports
    • Conduct defined training sessions with researchers responsible for direct handling of controlled substances in order to ensure their understanding of DEA requirements

    REQUIREMENTS:


    Education:

    • Bachelor’s degree in sciences with a minimum of 2 years of relevant science experience in Chemistry, Medicinal Chemistry, or related field preferred. 

    Languages:

    • English (written and spoken), other languages such as German and French would be advantageous
    • Experience/Skills:
    • Experience in a Pharmaceutical or Biotech company a plus
    • Comfort with tools and sites such as ChemDraw, JChem, SciFinder and related tool
    • Working knowledge or willingness to learn DEA and MDPH regulations regarding the handling of controlled substances is required
    • The individual must understand “customer focus” and be professional within workplace
    • Individual must be self-motivated, well-organized, reliable, and able to prioritize workload
    • Ability to work independently with some supervision
    • Good communication skills, collaboration, and follow through

     


    0 0
  • 01/14/16--00:45: Sci-Ops Move Associate
  • ***Please e-mail me with your resume and interest regarding this opportunity***

    Summary

    • We are looking for a mechanically skilled candidate to work with our SciOps team in support of the Cambridge campus expansion. You will be part of the Lab Operations team supporting the relocation of over 4000 items into the two new buildings here in Cambridge.
    • Ability to work effectively in a lab environment and have a familiarity with a variety of lab equipment.
    • Serve as a point of contact and liaison between internal groups and external vendors.
    • Assist with the timely execution of the move plan and preparations for the move.
    • Effectively communicate with various trade skills and gather required information about space and infrastructure requirements.
    • Assist with inventory updates and controls.

    Requirement

    • BS Degree
    • The ideal candidate would have experience in an industry setting.
    • Good personal and communication skills. The individual must understand “customer focus” and be professional within workplace.
    • Individual must be self-motivated, well-organized, reliable, and to prioritize workload.
    • Conduct activities in compliance with Novartis safety, waste disposal and other regulatory guidelines.
    • Identify and report unsafe equipment, conditions and practices so that they may be corrected prior to an incident.
    • An ability to multi task 
    • A basic understanding of lab equipment and services
    • Working knowledge of MS Office
    • Key words: Lab equipment, facilities operations, general contracting, project management, logistics

    0 0

    ***Please e-mail me directly with your resume and inerest in this opportunity***

    This temporary position provides operational coordination for three labs within Research, including the management of moves in the office and laboratory, monitoring and execution of research agreements, and management of multi-party research collaborations. This individual will also coordinate communications between scientists and our on-site vendor on laboratory supplies. Some budget tracking, invoicing, and management of project collaboration sites will be needed. 

    • Manage Lab and Office space moves for laboratories 
    • Track and facilitate the execution of research agreements, and interact with representatives from Legal department, Research Operations, contracting institutions, and investigators 
    • Track lab supplies budget, invoicing, purchase orders, and some support for the annual budget planning cycle 
    • Liaise with Facilities (Engineering, Lab Services, Site Services) and Environmental Health, Safety and Sustainability (EHS&S) to implement laboratory and office renovations as needed 
    • Manage project team collaboration sites, and data-sharing sites for multi-party external collaborations 
    • Knowledge of laboratory processes, and interfaces involved in providing operational support for discovery research 
    • Strong interpersonal and organizational skills, as well as patience and a steady commitment towards achievement of goals 

    Requirements:

    Bachelors degree with some experience in research administration, support services or research operations preferred. Research experience in a drug discovery environment is strongly desired.


    0 0
  • 01/14/16--01:04: Sci-Ops Move Associate
  • Job Description:

    Ability to work effectively in a lab environment and have a familiarity with a variety of lab equipment.
    Serve as a point of contact and liaison between internal groups and external vendors.
    Assist with the timely execution of the move plan and preparations for the move.
    Effectively communicate with various trade skills and gather required information about space and infrastructure requirements.
    Assist with inventory updates and controls.

     

    Requirements:


    BS Degree
    The ideal candidate would have experience in an industry setting.
    Good personal and communication skills. The individual must understand “customer focus” and be professional within workplace.
    Individual must be self-motivated, well-organized, reliable, and to prioritize workload.
    Conduct activities in compliance with all safety, waste disposal and other regulatory guidelines.
    Identify and report unsafe equipment, conditions and practices so that they may be corrected prior to an incident.
    An ability to multi task
    A basic understanding of lab equipment and services
    Working knowledge of MS Office
    Key words: Lab equipment, facilities operations, general contracting, project management, logistics


    0 0
  • 01/14/16--01:28: Bioinformatics Programmer
  • Compass Therapeutics is an antibody discovery and development company focused on comprehensively drugging the tumor-immune synapse with combinations of human monoclonal antibodies, multiclonals and engineered protein constructs.  Compass is industrializing antibody discovery and decentralizing biologic validation through a partnership-first mentality that leverages best-in-class technologies and top-tier academic laboratories around the world.  Novel scientific insights are validated and explored deeply inside our labs before Compass pursues the best proprietary combinations of therapeutics into human clinical trials.

    In 2015, Compass quietly closed a $120mm Series A financing to fund our ambitious plan to build a fully-integrated biopharmaceutical company from the ground up.  Our investors are among the most sophisticated venture capitalists in the industry who exemplify our philosophy of building long term economic value only by delivering therapeutics with meaningful efficacy beyond standard of care.  They include OrbiMed Advisors, F-Prime Capital (formerly Fidelity Biosciences), Borealis Ventures, Google Ventures and a handful of smaller VCs and passionate angel investors.

    Compass is a seeking Bioinformatics Programmer at our Cambridge, MA site.                                   .  

    Principal Responsibilities:

    • Maintain informatics infrastructure, including databases of protein and nucleic acid sequence, structure and function
    • Create scripts for data manipulation, processing and integration
    • Engineer web pages that present customized data views and analyses
    • Create interactive portals to Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebook (ELN) data according to user needs
    • Write code for primary research in cancer immunotherapy
    • Contribute to establishing and maintaining network and information technology at Compass
    • Cure cancer. 

    Preferred Qualifications:

    • Experience collaborating via github, SVN, or similar repository
    • Experience running and maintaining web servers
    • Familiarity with major biological databases (NCBI RefSeq, UniProt, TCGA)
    • Familiarity with modern analysis tools for RNA/DeepSeq and high throughput laboratory instrumentation
    • Experience developing Shiny pages and producing compelling visualizations with ggplot and/or matplotlib
    • Understanding of the fundamentals of molecular biology and a working knowledge of statistics
    • Ability to communicate directly with teams of biologists is ideal
    • Experience working in/out of a LIMS and modern laboratory instrumentation is ideal
    • Experience with Electronic Lab Notebooks 

    Basic Qualifications:

    • B.S. or B.A. in Computer Science, Bioinformatics or related field with relevant experience
    • Fluency in Python, SQL; database construction and maintenance; proficiency in R 

    Compass Therapeutics offers individually-tailored compensation packages which include competitive cash compensation, meaningful equity participation, comprehensive healthcare and adoption benefits, continuous career development, sabbatical programs, education reimbursement and many other benefits aligned with our philosophy of putting our team first.  Our labs are located at 450 Kendall Street in Cambridge, MA.


    0 0
  • 01/14/16--02:04: Associate Scientist I
  • Summary:

    The Respiratory Science group is looking for a highly motivated associate scientist with experience in electrophysiology to be part of a team committed to finding treatments for cystic fibrosis, COPD and other respiratory diseases. The successful candidate will be primarily responsible for primary cell culture (experience with aseptic technique is required), developing and conducting in vitro electrophysiological assays focused on ion transport and its roles in airway hydration. You will also be involved in new drug target identification and validation as well as investigating the mechanism of action of potential drug candidates. We are looking for a candidate who can utilize their strong technical and organizational skills and has an enthusiastic, collaborative spirit.

    Additional responsibilities include:
    1) Manage laboratory resources, i.e. reagents and supplies, performing routine maintenance and calibration etc.
    2) Analyze, interpret and present your results, participate in meetings with team members and other research staff to evaluate, interpret and quality-control the data you generate as well as to identify next steps
    3) Learn new techniques and approaches as required to tackle key scientific questions.
    4) Recognize and troubleshoot data anomalies to maintain high data quality

    Requirements:

    Education:

    • Bachelors or Master’s degree in Biology, Biophysics or related discipline

    Required Skills/Experience:

    • A minimum of two years of laboratory-based industrial or academic experience and/or training
    • Previous exposure to in vitro electrophysiology (high throughput platforms and/or ussings would be preferred)
    • Experience working with human primary cell cultures and other cell lines
    • Self-motivated and pro-active attitude, with the ability to multi-task
    • Solid work ethic and demonstrated record of productivity and high quality data
    • Intermediate/advanced ability with MS Office, especially Excel, and ability to learn new software
    • Excellent problem solving, organizational and experimental management skills
    • Strong written and verbal communication skills
    • Commitment to help the team achieve deliverables and meet aggressive timelines
    • Ability to be both independent as well as effectively interact with team members and work in a highly dynamic and collaborative environment

    Desired Skills/Experience:

    • Experience with cell-based high throughput screening assays
    • Familiarity with basic statistical analyses and how to apply them to biological data
    • Flexibility and willingness to occasionally adjust your hours as required by specific experiments

    0 0
  • 01/14/16--02:05: VP Clinical Development
  • Our client, a small oncology focused biotech in Lexington, MA is seeking a VP of Clinical Development to join their collaborative team. This is an excellent opportunity with exponential room for growth within a reputable company working towards developing innovative drugs for the treatment of human cancers to save and change lives. If you are an individual with strong organization, written and communication skills, with past experience in Clinical Development Plan generation, this is a not to be missed opportunity for you!

    This role will be essential to the development of plans including trial design, conduct, data analysis and medical monitoring of clinical studies. The selected high caliber individual will be supported and work directly with internal staff & consultants so a team player attitude is fundamental to this role. Strong academic background and training is strongly preferred.

    Requirements:

    • MD or MD/PhD (PhD in a scientific discipline is preferred)
    • Board certification in at least one medical specialty
    • Formal training in Medical Oncology and/or Hematology and/or extensive oncology clinical development experience is preferred
    • Ability to organize & prioritize workload
    • Strong interpersonal & organizational skills
    • Ability and willingness to travel up to 20% of the time (international and domestic)

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

    CHEMISTRY IS EVERYTHING™


    0 0
  • 01/14/16--02:40: Research Assistant I
  • Summary:

    • Responsible for the execution and analysis of experiments and analytical procedures. 
    • Displays an investigative or technological orientation in designing, executing and interpreting experiments and analytical procedures.
    • Provides assistance in the execution of experiments and analytical procedures by performing routine scientific procedures and experiments according to detailed protocols. 
    • Integrates, compiles, and tabulates data and reports results to supervisor (lab scientist). 
    • Work is closely supervised by lab scientist. 
    • Assignments are task-oriented with detailed instructions. 
    • Follows standard practices to obtain data. 
    • Contributes to the completion of routine technical tasks. 
    • Failure to achieve results can normally be overcome without serious effect on schedules and programs. 
    • Contacts are primarily with immediate supervisor and other personnel in the section or group. 
    • Conduct cell culture operations using shake flasks (125mL-3L scale) and multiwell plates with well established cell lines.
    • Record all work in laboratory notebook according to guidelines

    Requirements:


    Education:

    • BS in Biology/Biotechnology or equivalent

    Skills/Experience:

    • 1-2 years experience
    • Cell culture and sterile technique
    • General cell culture operations
    • Cell thawing, counting, scale up, and freezing; using lab equipment such as centrifuge, microscope, Vicell, BGA, and etc

    0 0

    Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.  The focus of this position is to support analytical characterization of cellular drug products primarily by flow cytometry.  We are looking for a motivated senior associate scientist with the experience and drive to take ownership of cellular analytics projects.

    Activities include:

    • Use flow cytometry and other immunological assays to characterize human primary cells freshly isolated and following ex vivo culture
    • Develop flow cytometry panels and standards to characterize primary cells from human bone marrow and peripheral blood
    • Aseptically FACS-sort cells for downstream colony forming assays and RT-PCR
    • All aspects of mammalian cell culture, including media and buffer preparation, culture initiation, propagation, and cryopreservation of cells, including primary human cells from commercial and/or patient sources 
    • Transduction of cells with lentiviral vectors
    • On-demand analysis of patient cells samples that may require working evenings and occasional weekends
    • Performance of general laboratory tasks, including maintenance of equipment
    • Maintain accurate and reliable record keeping including database management, batch records, notebooks, and all other pertinent documentation
    • Responsible for drafting process development reports
    • Provide input on development of new methods, techniques and evaluation criteria 

     

     

     

    Preferred Qualifications:

    • BS or MS cell biology, immunology or related discipline with at least 5 years' experience in the biotechnology or pharmaceutical industry
    • Independently motivated, detail oriented and good problem solving ability
    • Excellent organizational skills, sufficient to multi-task in a fast-paced environment with changing priorities
    • Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately
    • Well versed in a variety of cell based methods with a strong understanding of tissue culture, cell biology, immunoassays, and general laboratory techniques.
    • Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals 
    • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
    • Have experience with FACS staining  and operating various types of flow cytometers; experience using the BD LSR2/Fortessa, Miltenyi MACSQuant, and Sony SH800 or other cell sorters is highly favorable
    • Experience with designing and optimizing multi-color flow cytometry panels
    • Experience with BD Diva and FlowJo software
    • Willingness to work with lentiviral vector and human biological samples
    • Ability to take ownership of projects and results
    • Working knowledge of various computer software, hardware, and standard office sufficient to record scientific data and results, and prepare reports.
    • Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

    0 0
  • 01/14/16--23:15: RA - Mouse Modeling
  • OVERALL RESPONSIBILITY
    The Xavier lab is looking for exceptional candidates to join a multidisciplinary research team with the mission of systematically defining the regulatory networks that govern gut immune responses to better understand the pathogenesis of inflammatory bowel disease (IBD) in order to accelerate its treatment. We are using a combination of genomic methods, physiologically relevant cell-based assays, novel mouse models based on genetic variants identified in patients, patient samples, CRISPR-based gene editing, and computational analyses to understand disease pathophysiology.

    The successful candidate will be involved in a series of research activities, including experimental design and assay development using a variety of standard and novel techniques in genomics, molecular biology, biochemistry, genome editing and in vivo models. He/she is expected to work largely independently on a daily basis after training, but will be closely mentored by a senior researcher and other members of the team.

    The Broad Institute provides a vibrant research environment with close links to top academic institutions across the Boston Area and provides the potential for your contributions to be used and recognized worldwide.

    CHARACTERISTIC DUTIES
    - Designs and carries out small independent projects as well as basic bench level experiments and techniques
    - Uses discretion to plan project requirements and timelines
    - Analyzes experimental data and adjusts experimental protocols to ensure project completion in a timely fashion
    - Documents, compiles, and assists with interpreting experimental data. Reports data to supervisor and team
    - Attends team meetings to share results, plan projects and experiments, and to ensure that projects support current team goals in a dynamic environment
    - Consults with other senior scientists or scientific literature as needed
    - Operates and maintains automated laboratory equipment to complete investigations. Prepares, orders, and maintains stocks of necessary reagents, solutions and supplies
    - Bachelors or Master’s degree in biology or related field required
    - Must possess at least 1 - 2 years of experience in a research laboratory, preferably in an independent project (Master’s degree, at least one year of directly related, full time lab experience)
    - Must possess excellent molecular biology and tissue culture skills
    - Experience working with mouse models highly desirable.
    - Excellent communication skills and the ability to interact professionally with all levels of staff and with collaborators in a fast paced environment required
    - Must be able to use sound judgment to handle a variety of tasks and to shift priorities simultaneously, as well as to effectively solve problems.
    - Must possess a high level of initiative and the ability to work with little supervisionThe Broad Institute will not offer visa sponsorship for this opportunity.

    EOE/Minorities/Females/Protected Veterans/Disabilities #LI-post

    To apply for this position, please CLICK HERE


    0 0

    Our lab’s mission is to uncover biological knowledge by developing advanced methods to quantify and mine the rich information present in images. We love working as a team towards scientific goals: discovering the inner workings of biological systems and influencing patient treatment. We love making open-source software that impacts the world. We are conscientious and enjoy a professional environment.

    This is an opportunity to make important contributions through many different individual projects as well as by supporting thousands of researchers around the world who are accomplishing great things with our lab’s open-source software, CellProfiler. CellProfiler is launched 130,000+ times per year around the world by scientists quantifying biological processes in images. Cited in more than 3,000 scientific papers, it has led to potential therapeutics related to the Ebola virus, tuberculosis, AMKL, leukemic stem cells, and CCM.

    Responsibilities:
    Deep impact, on important biomedical research projects:
    - Develop image analysis pipelines using CellProfiler, working in-depth with brilliant biomedical researchers to push forward the boundaries of what can be extracted from high-throughput imaging experiments.

    We collaborate with dozens of biomedical research laboratories to identify disease states, potential therapeutics, and gene functions from microscopy images.

    Broad impact, supporting the CellProfiler community:
    Support thousands of CellProfiler users worldwide by answering questions at our popular online forum. Deliver educational workshops on image analysis and the usage of CellProfiler (including traveling 5+ days/year).

    Grow:
    - Opportunity for advancement, taking on administration and management of the team’s many projects.

    B.S. in science:
    - life sciences, physical sciences, or computational sciences.

    - Strong understanding of biology
    - Significant experience using image processing software on biological assays

    Preferred but not required:
    - CellProfiler expertise, programming experience (Python - though we are not looking for a computer scientist to develop novel computational algorithms from scratch), and experience with Linux environments, databases, computing clusters, and bioinformatics/statistics tools (e.g., R).

    - Able to clearly communicate with biology collaborators about project aims and results, and with software engineers on the team about image processing and software needs
    - A personality that is helpful, professional, highly organized, and goal-oriented, efficiently juggling projects and competing demands

    EOE / Minorities / Females / Protected Veterans / Disabilities

    To apply for this position, please CLICK HERE


    0 0

    Don't miss your chance to join a high-profile, public therapeutics company with programs advancing through the clinical process.  They are seeking experienced QC professionals to join their small, but growing, team as they develop their QC infrastructure and help advance life-saving therapies to market.  This role will be focused on cell-based/bioassay, flow cytometry, residual host cell protein and other non-traditional QC methods.    

    The main function of this role is to transfer, qualify/validate and troubleshoot test methods.

    Responsibilities include but are not limited to;
    •  Draft phase-appropriate qualification/validation protocols and reports  
    •  Review release and stability data and identify and investigate potential data trends
    •  Support process characterization activities and CMC sections of regulatory filings

    Formal descriptions can be supplied for interested candidates. 

    Qualified candidates will have a BS or MS degree in a life science discipline and 2-5+ years of experience.  The Hiring Manager has the ability to consider more experienced QC professionals and will title the role appropriately.  Strong knowledge of cGMP/ICH/FDA/EU regulations is also required.      

    Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area or able to relocate with very limited assistance.  

    All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.


    0 0

    Manufacturing Science and Technology Specialist (Downstream)

    About Acceleron:

    Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic candidates that regulate cellular growth and repair.  The company is a leader in understanding the biology of the Transforming Growth Factor-Beta (TGF-β) protein superfamily, a large and diverse group of molecules that are key regulators in the growth and repair of tissues throughout the human body, and in targeting these pathways to develop important new medicines. Acceleron has built a highly productive R&D platform that has generated innovative clinical and preclinical protein therapeutic candidates with novel mechanisms of action.  These protein therapeutic candidates have the potential to significantly improve clinical outcomes for patients with cancer and rare diseases.

    Position Overview: 

    We are seeking an experienced and talented individual who thrives in a dynamic, fast-paced, team-oriented and collaborative environment.  The successful candidate will work in the Manufacturing Science and Technology group within the protein purification area and collaborate closely with the Process Development Protein Purification group. MSAT performs Pilot and GMP campaigns as well small scale experiments in the Development setting as needed. The group investigates new technology that would be useful for Acceleron, evaluates multiple options and is responsible for the implementation at Acceleron. The preferred candidate will have experience in single use manufacturing technologies. This position will also interact closely with the Development, Quality, Engineering and Materials Management groups. 

    Job Responsibilities:

    • Support scale up studies for process transfer between Pilot and GMP manufacturing
    • Execute and demonstrate an understanding of protein purification techniques including column chromatography and various filtrations (virus removal, bacterial reduction, membrane, tangential flow)
    • Perform Pilot and GMP runs at scale for multiple products
    • Investigate new technology and purification techniques that will be useful in expanding and enhancing Acceleron’s platform manufacturing process.
    • Assist in design and completion of purification studies to optimize processes to be used in the pilot or GMP facilities
    • Keep up with technological advances by attending workshops and industrial exhibits
    • Monitor, document and present purification process data
    • Author SOPs, batch records, change controls, deviations, and support Engineering with PQ, IQ, and OQ activities
    • Work closely with other groups (QA, QC, Engineering, Facilities) for campaign planning and execution (schedule, raw materials orders, testing, etc)
    • Author technical reports for runs performed (Pilot and GMP campaigns)
    • Interact closely with multiple interdisciplinary groups (QA, QC, Purification Process Development, Facilities, Cell Culture Development, etc)
    • Support regulatory filings with manufacturing process descriptions and data summaries
    • Interact closely with vendors for raw material procurement and new technology implementation
    • Participate in internal and external audits
    • Support tech transfer activities to CMOs in regards to MSAT activities

    Basic Qualifications:

    • B.S. with 3-7 years of experience or MS with 1-3 years of experience with Pilot or GMP production
    • Industry experience (biotech or pharmaceutical) required, in GMP setting preferably
    • Excellent knowledge of purification techniques (aseptic processing, column chromatography, virus removal filtration, tangential flow filtration etc)
    • Experience drafting, reviewing and submitting required documentation relevant to GMP manufacturing
    • Technical expertise and creative problem-solving ability
    • Ability to work independently, with minimal supervision, and to manage multiple projects at one time
    • Enthusiastic with a high-level of integrity and attention to detail
    • Strong interpersonal communication skills, work in team and fast pace environment, under challenging timelines and hands-on troubleshooting, great organizational and time management skills

    *Recruiters - please do not send unsolicited resumes to this posting.

    FOR IMMEDIATE CONSIDERATION PLEASE VISIT OUR WEBSITE AT:

    www.acceleronpharma.com


    0 0

    Senior RA / Scientist, Cell Line Development/ Early Stage Process Development

    About Acceleron:

    Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic candidates that regulate cellular growth and repair.  The company is a leader in understanding the biology of the Transforming Growth Factor-Beta (TGF-β) protein superfamily, a large and diverse group of molecules that are key regulators in the growth and repair of tissues throughout the human body, and in targeting these pathways to develop important new medicines. Acceleron has built a highly productive R&D platform that has generated innovative clinical and preclinical protein therapeutic candidates with novel mechanisms of action.  These protein therapeutic candidates have the potential to significantly improve clinical outcomes for patients with cancer and rare diseases.

    Position Overview: 

    We are seeking an experienced and talented individual who thrives in a dynamic, fast-paced, team-oriented and collaborative environment.  The successful candidate will work in the Cell Line Development area within the Process Development group and provide technical expertise across all stages of the protein therapeutic development life-cycle for multiple projects. This position will interact closely with the Research group but also the Manufacturing group where the cell lines and processes developed will be produced for clinical purposes.

    Job Responsibilities:

    • Create cell lines to produce recombinant proteins, monoclonal antibodies, and other novel molecules
    • Perform transfections, amplifications, limited dilution cloning steps as well as screening tests to generate stable GMP cell lines
    • Collaborate with external partners and vendors on projects relating to cell line development
    • Design and perform DoEs to optimize media and feed components at small scale
    • Perform early stage  process development in shake flasks, Wave bags, and small scale bioreactors to define basic cell culture process
    • Support Process Development group in production of material at larger scale for Pilot needs (up to 250L scale)
    • Actively pursue and implement new methods/technologies designed to improve and stream-line the activities of the cell line development area
    • Author and review relevant CMC sections for regulatory filings (e.g. IND, IMPD, etc.) as well as provide technical oversight for responses to regulatory agency comments/recommendations
    • Support MSAT group for tech transfer to a GMP setting as well as cell line testing post cell banking (ie cell line stability studies)
    • Support internal investigations and process development activities
    • Effectively interact and provide support to Research and Development groups internally as well as CMOs and vendors/collaborators/partners during technology transfer activities
    • Effective communication of results through written documentation and oral presentations

    Basic Qualifications:

    • BSc. in biology or related field with 7+ years of industrial experience or MS 5+ years of experience
    • Excellent knowledge of cell biology and cell culture techniques (aseptic processing, cell line development,  use of Wave bags etc)
    • Excellent knowledge of tests for protein analysis (titer, Western blots, ELISAs, Octet etc) is required, knowledge of tests for protein quality is preferred
    • Prior experience in cell line development
    • Ability to manage multiple projects at various stages of
    • Experience working with external collaborators or CMOs is preferred
    • Experience drafting, reviewing and submitting required documentation relevant to Regulatory filings
    • Technical expertise and creative problem-solving ability.
    • Ability to work independently, with minimal supervision, and to manage multiple projects at one time
    • Enthusiastic with a high-level of integrity and attention to detail

    *Recruiters - please do not send unsolicited resumes to this posting.

    FOR IMMEDIATE CONSIDERATION PLEASE VISIT OUR WEBSITE AT:

    www.acceleronpharma.com


    0 0

    Responsibilities:

    This person will be leading developmental project teams in design, optimization and characterization of purification processes for manufacture of monoclonal antibodies, bispecific antibodies, antibody fragments and non-antibody based proteins.

    Requirements:

    • MS/PhD with 5+ years of process development experience in biopharmaceutical industry
    • Experience in process chromatography, ultrafiltration / diafiltration, and other separation technologies is required.

    0 0

    Research Associate, Preclinical Pharmacology

    About Acceleron:

    Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic candidates that regulate cellular growth and repair.  The company is a leader in understanding the biology of the Transforming Growth Factor-Beta (TGF-β) protein superfamily, a large and diverse group of molecules that are key regulators in the growth and repair of tissues throughout the human body, and in targeting these pathways to develop important new medicines. Acceleron has built a highly productive R&D platform that has generated innovative clinical and preclinical protein therapeutic candidates with novel mechanisms of action.  These protein therapeutic candidates have the potential to significantly improve clinical outcomes for patients with cancer and rare diseases. 

    Position Overview

    We are seeking a highly motivated individual who thrives in a dynamic, fast-paced, team-oriented and collaborative environment to be part of our success in the preclinical pharmacology group.

    The successful candidate is expected to perform in vivo experiments including rodent models of liver, lung, kidney, and cardiac fibrosis models; perform sample collections and the related endpoint analysis; and perform in vitro experiments including QPCR, ELISA, MSD, and protein analysis. A proven track record of use of in vivo disease models and conducting studies to evaluate efficacy and mechanism of action of potential therapeutic agents is critical. Experience in at least one model of fibrosis and a willingness to learn about additional models is expected. The candidate must have strong written and oral communication skills, be self-motivated, a team player and able to work independently.

    Job Responsibilities:

    • Perform experiments to evaluate efficacy and mechanism of action of protein therapeutic agents
    • Hands on capabilities working with rodents, excellent trouble shooting skills, in depth knowledge of in vivo model systems and familiarity with molecular and cell biology experiments
    • Work with cross functional drug development group to bring research stage molecules to clinical development
    • Independently review the scientific literature for advances in fibrosis and the related fields
    • Prepare, present and review scientific presentations for internal/external use

    Basic Qualifications:

    • BS degree with 5+ years or MS degree with 2+ years of academic or industrial experience in animal model development
    • Excellent rodent handling and injections skills
    • Able to work independently on design and implementation of experiments
    • Ability to prioritize responsibilities to meet project deadlines.
    • Prior experience in models of organ fibrosis
    • Experience with RNA expression, ELISA, IHC and protein expression methods

    *Recruiters - please do not send unsolicited resumes to this posting.

    FOR IMMEDIATE CONSIDERATION PLEASE VISIT OUR WEBSITE AT:

    www.acceleronpharma.com


    0 0
  • 01/15/16--01:05: Lead Clinical Data Manager
  • Primary Roles:
    The Clinical Data Manager will have a demonstrated ability to oversee the data management activities across a single clinical program or group of related studies. Provides Data Management leadership and expertise to project and study teams. Will have an good knowledge of the end to end clinical research and data management processes, as well as global regulatory and industry rules and guidance (i.e. ICH, GCP) to support drug development processes and global project submissions through to approval. Responsible for managing data management components of project and study budgets and vendor performance. May mentors team members and more junior staff and may direct activities of contract Data Manager staff

    Responsibilities:
    30%
    Delivering Excellence:
    Takes leadership role in project implementation
    * As a member of the clinical study or project team, ensures oversight of the Data Management CRO ; provides status reports/updates, resolves disputes, and ensure
    s timely acquisition of high quality deliverables from the CRO
    * Provides Data Management expertise to the team in identifying opportunities for process and budgetary optimization
    * Coordinates with Biostatistics and Statistical Programming to ensure appropriate design, documentation, testing and implementation of SAS data deliverables according to internal and regulatory standards
    * Works with team members via matrix relationships (internally or at CROs) by directing work, resolving problems and/or providing guidance

    25% Accountability and Ownership: Drives accountability at every possible level
    * Ensures Data Management CROs are delivering quality data and documentation on time, on budget and to Shire's quality standards and SOPs
    * Reviews Data Management CRO performance measures and evaluates cost/benefit of actions taken to remedy or improve performance
    * Collaborates with CRO and study team members to identify and resolve issues impacting goal attainment.

    15% Judgment and Decision Making: Evaluates immediate business impact and takes decisive action
    * Provides within and between study comparisons of DM timelines for assigned projects. Takes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve
    * Contributes to regular budget forecasting and regular cost accrual processes and proactively communicates to the team budgetary impacts of decisions or processes implemented to achieve results

    10% Courage to challenge: Takes risks and challenges norms to support tomorrow's needs
    * Supports consistent implementation of globally agreed study delivery and clinical development strategies including process and technology related to DM Operations

    10% Serving Customers: Partnering with customers as a trusted consultant and becoming an integral part of customer's decision making
    * Supports each clinical study and project team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines. Consults with the team(s) to ensure the teams' long-term needs are addressed.
    * As Data Management lead to the clinical study, becomes involved in decision making processes to ensure maximum performance of the team. Provides Data Management expertise to the teams in customer oriented point of view
    * Leads development of Data Review Plans; contributes to other key study level documents (e.g. protocols, SAPs)

    10% Building Authentic Relationships: Building trusting relationships that will enhance current and future needs
    * Leads in developing trust through transparency in communication and individual actions; ensures outcomes are team driven rather than individually driven; promotes collaborative team and organizational success

    Education and Experience Requirements:
    * B.S. degree in Scientific or related field is preferred.
    * Minimum of 5-7 years as a Sr. Data Manager within a Data Management organization
    * Experience with leading teams and/or organizations.
    * CCDM certification preferred

    Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=c3N6Y3plc255LjExNTExLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


    0 0

    Primary Role
    The R&D Global Regulatory Affairs and Quality Assurance and Control IT Solution Architect will establish the application/integration blueprint and standards for the business domain. Work in collaboration with Enterprise Architects, Technical Architects and other Solution Architects to establish an overarching Enterprise Architecture that leverages and integrates shared and common technologies that adhere to agreed application standards.

    The Solution Architect will provide business domain and technology or process knowledge/experience to advise on appropriate technology options suited for the business capability to be delivered. Ensure that the architecture design satisfies the architecturally-significant requirements and collaborate with technical and enterprise architects as appropriate in the design process. The solution architect will be responsible for the technical design of a new capability based on the strategic value/impact of the solution for the R&D organization.

    He or she will work in collaboration with the Head of "Business Function" Architect, Business Partners and Application Service Managers to ensure the state of the system (application and underlying infrastructure components) is captured and technical, operational, demographic and architectural attributes of the systems are accurately maintained in Shire's systems of record. The Solution Architect will also act as a consultant/advisor to the business function on demand and provide review and oversight of application lifecycle management changes.

    Responsibilities
    20% Define standards and strategy
    * Create application/integration blueprint and standards for the R&D systems
    * Assist in the creation, development, management and performance of the defined IT service organization
    * Participate in relevant road mapping and business case development activities to provide input on new projects (e.g. for new capabilities, lifecycle refresh and enhancements)

    30% Design
    * Provide technical leadership in the selection, design and configuration of the application in addition to mapping client business requirements to systems/technical requirements
    * Formulate and define scope and objectives pertaining to the IT systems
    * Provide design input on new services and solutions (e.g. solution architecture, app security, support model)
    * Ensure Disaster Recovery requirements, both RPO and RTO are incorporated into system designs and standards as and where appropriate
    * Develop and document the system design specifications as part of any new project and then maintain thereafter.

    30% Manage
    * Manage and maintain SEAMs to ensure it is up to date and representative of the R&D business processes
    * Create and then maintain the System Design Specification for all systems in their control.
    * Work closely with the Infrastructure teams to understand their future technologies roadmaps and the impact that has on the existing systems or future projects
    * Ensure the state of the system (application, data, integration and underlying infrastructure components) is captured along with business fit, technical, operational, demographic and architectural attributes of the systems are accurately maintained in Shire's systems of record

    20% Develop partnership, team work and innovation
    * Assist key IT stakeholders in the capacity forecasting and planning estimates relating to the portion of the IT project portfolio that falls within the Solution Architect's associated remit
    * Development and enforcement of architectural standards and adherence to procedures and to ensure consistency and synergy in approach to other peer groups

    Education & Experience Requirements
    * Bachelor's degree in computer science, information systems, business administration or other related field (or equivalent work experience).
    * Experience in the Pharmaceutical industry is essential. Specific experience in Regulatory Affairs and QA&C is crucial, with good business process skill and a high understanding of the technologies, tools and systems used throughout.
    * Strong knowledge of IT Computer Systems Validation processes is required.
    * 10+ years of IT consulting and working in complex, global matrix organization is preferred.
    * Pharmaceutical experience specific to and with knowledge of R&D business processes
    * Typically at least three to seven of IT work experience related to application architecture and related technologies (required).

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process

    Please apply at: Application URL:http://www.aplitrak.com/?adid=Y3J5ZGJlcmcuNjAxMDIuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20


    0 0
  • 01/15/16--01:15: Clinical Programs Scientist
  • Primary Role:
    * Manages or assists in the planning, implementation, and execution of a clinical research study(ies).
    * Manages clinical outsourcing to CROs and other vendors such as IVRS, labs, IRBs, etc.
    * May author, review and approve various study related documents and plans.
    * Leads cross functional teams and is responsible for the oversight and management of study timelines as well as the financial management of a study.

    Responsibilities:
    10%:
    * Leads and/or assists the study team to design, develop and deliver the clinical study to agreed upon timelines.
    * May assist in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and vendors.

    40%:
    * Leads and/or assists the study team to execute the clinical study in accordance with the clinical development plan/strategy and timelines.
    * Contributes to the clinical review of Case Report Forms (electronic as applicable), data review plan, and other data management documents and corresponding completion guidelines.
    * Leads/assists in oversight of the identification and selection of investigator sites.
    * Assists and/or participates in planning and conduct of investigator's meetings.
    * Provides input and coordinates the delivery of clinical trial supplies in collaboration with clinical supply team.
    * Collaborates with the cross functional team on selection and potentially management of clinical vendors.
    * Liaises and coordinates with document specialists regarding study files.
    * Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
    * May support or co-manage larger complex trials as necessary.

    40%:
    * Leads and/or assists in the oversight of CRO activities and other clinical vendors to ensure the quality meets Shire and regulatory requirements.
    * Monitors the status of clinical data collection of assigned clinical studies.
    * May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance.
    * Reviews clinical monitoring reports and correspondence related to monitoring visits.
    * Responsible for maintaining tracking information in the clinical trial management system and confirming resolution of data quality issues with the CRO.
    * Ensures effective communication between Shire and the Clinical CRO.
    * Reviews and approves study plans.
    * Oversees and monitors the management of the clinical study, ensuring it is conducted in accordance with the approved study plans.
    * May provide periodic status reports regarding study timelines, budget issues, accruals, etc. to Global Clinical Operations Lead (GCOL) as requested.

    5%:
    * May develop and/or monitor budget for clinical study (investigational sites and vendors).
    * May generate or assist in critically evaluating proposals, contracts, and change orders from CROs and other vendors.

    5%:
    * Develops knowledge of therapeutic area, current medical practice and industry regulations in order to ensure best practice across all activities.
    * Supports departmental initiatives and process improvements.

    Education & Experience Requirements:
    * Bachelor's degree or nursing qualification is required. Scientific/health care field preferred, but not required.
    * Experience (2+ years) working in clinical research within a pharmaceutical company or CRO or similar organization.

    Other Job Requirements: Available for up to 25% domestic and/or international travel.

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=YWthbmVyLjg2Njk0LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


older | 1 | .... | 841 | 842 | (Page 843) | 844 | 845 | .... | 855 | newer