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our client is looking for an associate scientist in cambridge, ma. this is a long term position. Job Description We are seeking motivated and creative individuals to join our Cell Line Development team through April 2013 and contribute to ongoing efforts to engineering superior host cell lines for the manufacturing of therapeutic proteins. The successful candidate will have mammalian cell culture/cell line development experience. Candidates with experience performing transfections, basic molecular ...

Seeking a seasoned scientific professional who is proficient with all facets of downstream protein manufacturing from pilot to production scale and who is ready to transition into hands on leadership role Requires 4+ years experience developing purification processes for proteins, enzymes, PEGylated proteins, antibodies, or peptides to be scaled up and transferred from development to clinical and commercial manufacturing. Join a company focused on the future. Offering extremely generous ...

Provide strategic leadership for teams focused on the development of personalized medicine based on the discovery of molecular biomarkers. Utilizing patient derived data from genomic and molecular analyses you will develop strategies to drive oncology therapeutics through the clinic Shall: *** Work with clinicians and laboratories to develop novel biomarkers, research tools and study designs derived from the safety, pharmacokinetic and pharmacodynamic data obtain in the early phase trials. *** ...

  Work Description Manages all regulatory interactions with local health authorities in the US and Canada. Provides input into the development of regional RA strategies- Central contact point for all Novartis Vaccines regulatory interactions with the respective local Health Authorities- Monitors local guidelines and vaccine specific recommendations- Prepares and/or comments on draft documentation sent out for consultation from the health authority- Input to Regulatory Operations of local ...

MEDICAL TECHNOLOGIST (ASCP) Seeking a technically skilled and highly motivated Medical Technologist to perform moderate to high complexity testing of esoteric assays. As a member of our team you will be responsible for: - Managing assigned tests by adhering to the laboratory’s standard operating procedures - Analyzing specimens, interpreting and recording testing results, and reporting results utilizing a wide variety of technologies and instruments. - Performing a variety of ELISAs, neutralization ...

Responsibilities: • The person in this function will be responsible for developing purification processes for manufacturing novel viral vaccine candidates for toxicology studies and Phase I/II/III clinical trials. • Execute experiments in close collaboration with Research and Technology Development team to establish Phase I-III clinical manufacturing process • Perform activities in support of definition of bulk purification processes for novel viral vaccine candidates (virus/virus-like particles, ...

Responsibilities: Job Description: We are seeking a highly motivated scientist to join our Diagnostics team. The major responsibilities for this individual include but are not limited to: • • Work closely with the development team to contribute to the development of real-time PCR based IVD tests. • • Perform some design of experiments with moderate guidance. • • Independently execute experiments with good quality, including sample preparation from FFPE tissue samples, real ...

Responsibilities; We are looking for a mechanically skilled candidate to maintain our fleet of open access LC-UV-MS-ELSD analytical and prep instruments. You will be part of an Open Access Engineering team supporting Chemists and Biologists for their open access sample analyses. Training will be provided, as needed. • Act as the primary support engineer for instrumentation within the Open Access labs of our Analytical Sciences and Chemistry departments in Cambridge, MA. • Keep instruments running at ...

Contract/Temp Scientist – Molecular Diagnostics Work with a team to contribute to development projects. Responsibilities include but are not limited to: 1) Provide steady support in documentation of protocol writing, project organizing efforts, good understanding and past experience in IVD environment and documentation are preferred. 2) Contribute intellectually in a team setting and communicate closely with manager / team to seek consensus in plan execution. 3) Independently carry out experiments ...

Responsibilities: • Responsible for input including: documentation, application forms, regulatory submissions (briefing documents/INDs/BLA's/Post Marketing submissions, etc.) • Prepares and reviews local labels. In consultation with Sr. Managers, contributes to regulatory interactions with local health authorities in the US and Canada. • Provides input into the development of regional RA strategies. • Contact point for all regulatory interactions with the respective local Health Authorities. ...

Description: Support the operational execution of the clinical study strategies related to biomarker and pharmacokinetic assessments in oncology protocols, in compliance with client’s processes and regulatory requirements and in collaboration with Oncology Clinical Teams. Responsibilities: • Sample tracking for biomarker and pharmacokinetic samples from clinical site to analytical laboratory. • This includes setting up the laboratory procedures, being the primary point of contact and providing ...

We are looking for a highly motivated senior level Director to work closely with key clinical personnel to optimize preclinical strategies focused on pharmacodynamic and predictive biomarkers. Shall: *** Generate strategies utilizing your expertise in cancer signaling pathway biology *** Drive the discovery of biomarkers related to molecular mechanism of action, pharmacodynamics and predictors of resistance pathways *** Provide scientific expertise to teams developing biomarker assays ...

We are seeking a dynamic thought leader in oncology to develop pre-clinical biomarker strategies derived from clinical data analysis. You will provide scientific and strategic leadership to support oncology molecules in all phases of development. Shall: *** Oversee the development of biomarker strategies and ensure successful execution of drug-diagnostic development *** Leverage your expertise to drive the publication of biomarker data in high quality scientific, technical, and medical ...

Seeking expert knowledge of assay design and execution specifically for cell based assays, biochemical assays, and histological tests as well as a documented history of effective leadership in a drug discovery environment to lead a small scientific team focused on identifying and evaluating gene expressed proteins or peptides acting as renal biomarkers. PhD relevant field and at least 4 years similar experience required. Advance rapidly in this highly visible position. Top compensation package ...

Major developer of novel renal therapeutics seeks 3+ years experience and strong working knowledge of in vivo pharmacology techniques to: *** Prepare test compounds *** Handle and dose mice *** Collect blood and tissue samples for PK and PD biomarker analysis *** Establish PK-PD relationships from in vivo assays *** Generate human dose predictions for clinical development *** Assess the mechanism of action and therapeutic viability for novel renal therapies PhD Life Sciences, ...

Associate Director, Regulatory Affairs Cambridge, MA Contract: 12 months renewable     Position Summary: This individual is expected to provide leadership within the Regulatory Affairs Labeling group and will be responsible for actively contributing to the development and implementation of regulatory labeling strategy and documentation for marketed products and products in development. This person will serve as the Regulatory Labeling representative on relevant project teams.   Duties and ...

 My name is Myesha Oliver and I represent The Fountain Group.  We are a national staffing firm and are currently seeking Mgr Quality Assurance for a prominent client of ours.  This position is located in Lexington, MA. Details for the positions are as follows:   Job Duties: Job Description:   Primary Role: This individual will work in the Quality Assurance department as part of External US QA. This individual will provide QA support of expansion into global supply of commercial Diagnostic Kits, ...

Seeking Ph.D. or M.D. and 10+ years in pre-clinical drug discovery and development for autoimmune, inflammation or respiratory therapeutic target entities including the development of in vivo, in vitro and ex vivo evaluation models. Shall: *** Participate in selection of specific protein & antibody entities as novel targets or drug leads for therapeutic consideration and develop research strategy. *** Supervise development of in vivo, in vitro and ex vivo evaluation models. *** Oversee ...

Seeking a scientific leader to oversee the development of preclinical models of inflammatory diseases to support clinical development collaborations, based on the pathophysiology of disease and the mechanism of action of drugs. Shall: *** Prepare, initiate, and manage all preclinical research studies *** Establish collaborations with pharmaceutical and academic organizations *** Manage a team of up to 10 Scientists Candidate must have 10+ years similar experience and possess PhD in Biology, ...

DUTIES: Job Description: We are seeking a highly motivated scientist to join Novartis Companion Diagnostics (CDx). The major responsibilities for this individual include but are not limited to: • • Work closely with the development team to contribute to the development of real-time PCR based IVD tests. • • Perform some design of experiments with moderate guidance. • • Independently execute experiments with good quality, including sample preparation from FFPE tissue samples, ...

  Position Summary:  Develops and implements validation and qualification policies, procedures and protocols.  Reviews and analyzes protocol data to determine if requirements are met.  Prepares and submits protocol reports for internal and customer review.  Recommends corrective action where necessary and develops master validation plans.  Assist with all activities for handling Finished Product from receiving to shipping as well as assessing and ensuring compliance through training, auditing ...

Please read the entire job description below and if you are qualified, send your most current resume in a Word document to: [email removed] DUTIES: Manages all regulatory interactions with local health authorities in the US and Canada. Provides input into the development of regional RA strategies - Central contact point for all regulatory interactions with the respective local Health Authorities - Monitors local guidelines and vaccine specific recommendations - Prepares and/or comments on draft ...

Seeking experienced field service technician who can: interact regulatory with customers including equipment demonstrations and training; install, configurte, calibrate, troubleshoot and validate systems; and regularly upgrade, repair and conduct preventative maintenance in the field. Must have 5+ years experience setting up, installing, troubleshooting, validation and traing in the field for laboratory instrumentation, biopharma production equipment, or similar and solid electromechanical ...

Great position for individual who likes to travel around the United States. Top compensation package including incentives, full company paid family health benefits, extensive training in latest molecular biology lab technologies, expense account and more. Seeking good electromechanical apptitude and knowledge of plumbing, light electrical, pnuematics, hydraulics and MS Windows software in person with 5+ years experience setting up, installing, troubleshooting, validation and traing in the field for ...

Seeking 5+ years experience setting up, installing, troubleshooting, validation and training in the field for laboratory instrumentation, biopharma production equipment, or similar. Shall: *** Interact regulatory with customers including equipment demonstrations and training. *** Install, configurte, calibrate, troubleshoot and validate systems. *** Regularly upgrade, repair and conduct preventative maintenance in the field. Requires good electromechanical apptitude and knowledge of ...

As a Medical Technologist II, you will perform the daily activities as described below. Duties and Responsibilities: 1. Must demonstrate proficiency in all principle duties of a Medical Technologist I. 2. Must be proficient in all applicable areas of testing in the department. 3. Proficient in troubleshooting all applicable instruments/procedures in the department. 3. Participate in continuing education; present periodic in-service programs. 4. Make suggestions for improvements; actively participate ...