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    Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and experimental drug candidate, we seek to improve the care of patients suffering from life-threatening diseases around the world. Our portfolio of 14 marketed products includes a number of category firsts, including the only complete treatment regimens for HIV infection available in a once-dailysingle pill -- Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), approved in 2006, and Complera?, approved in 2011. Manager, EH&S Specific Responsibilities This position is responsible for planning and coordinating daily activities required to facilitate Oceanside's EH&S programs. Monitors program execution to ensure compliance with federal, state and local regulations. Serves as a technical expert and resource to staff by answering questions and interpreting EH&S policy and procedures. Develop, implement and monitor company wide EH&S programs. Conduct safety hazard evaluations through facility inspection and perform root cause analysis for identified issues. Develop and conduct training sessions for site staff. Essential Duties and Job Functions Lead for local issues. Consults with senior managers or EH&S Director for guidance. Has significant local impact. Majority of contact is within company. Contact with other locations within the company on a frequent basis. External contacts with vendors are on routine matters. General direction. Limited supervision. Work is reviewed for adequacy of meeting objectives and deadlines. Written work requires very little review prior to distribution. Is very proactive. Anticipates. Must be able to speak in front of entire facility population or professional groups of equal size. Makes decisions' regarding local programs. Consults with senior mgmt. for non-routine decisions with significant impact. Manages multiple projects of significant complexity & risk. May be assigned as supervisor for some EH&S staff. Working towards certification in Certification (CIH, CSP, NRRTP, CHP, PE, etc.) Has a thorough understanding of requirements, interpretations, policies, consensus standards, and agency procedures. Accompanies regulatory agency personnel on routine site inspections. Participates as an audit team member for cross-functional audits; serves as lead auditor for audits of other sites. Manages site Emergency Response Team. Knowledge, Experience, and Skills Typically requires BA or BS degree and minimum 8 years of relevant experience. Must have a solid track record of adherence to schedule / budget. High degree of commitment demonstrated. Broad skills. Must be able to coach others in such skills. Selects standard methods. Budgeting/Financial Software, Cost-Benefit modeling, Defines system requirements for specialized EH&S applications that cross-geographical boundaries. To apply for the position, please click here. Gilead is an equal opportunity employer. Location: Oceanside Principals only. Recruiters, please don't contact this job poster. Please, no phone calls about this job! Please do not contact job poster about other services, products or commercial interests.
    losangeles.craigslist.org   ...Read On



    Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and experimental drug candidate, we seek to improve the care of patients suffering from life-threatening diseases around the world. Our portfolio of 14 marketed products includes a number of category firsts, including the only complete treatment regimens for HIV infection available in a once-dailysingle pill -- Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), approved in 2006, and Complera?, approved in 2011. Sr. Distribution Specialist II Specific Responsibilities This candidate will be responsible for the day to day Materials Management warehouse activities. This includes: ?GMP, Non-GMP and MRO materials supporting the site customers - research and development, Manufacturing, Maintenance and support groups as required. ?Perform all receipt/distribution activities, raw material sampling, labeling, storage, segregation per appropriate procedures. Develop and/or modify Standard Operating Procedures, address discrepancies and serve as point of contact for warehouse related requests. ?Adhere to all Department of Transportation, OSHA and Code of Federal Regulations requirements for material handling and biologics Essential Duties and Job Functions - Maintains a tidy and safe work environment - Complies with all established SOPs in performance of job. Adheres consistently to cGMPs. Complies with all safety-related procedures and practices personally and in area. - Operates a forklift in a safe and efficient manner - Samples chemical raw materials independently - Ships and receives materials - Receives bulk solvent deliveries - Responsible for one area of warehouse operation (i.e. shipping receiving or the Sampling room) Knowledge, Experience, and Skills - Problem Solving -- level of independence and ability to solve more complex and less routine problems continues to evolve. Begins assisting more junior staff in the development of problems solving skills/resources. - Business Communication -- Well established internal contacts. Expressing a higher level of confidence in use of logical persuasion. Beginning to establish understanding of primary external influences with regards to own work area. - Planning - confident to establish work priorities and complete tasks within a reasonable time period. Modifies plans as necessary to meet changing needs. - Impact and Influence -- displays confidence in own capabilities to complete routine tasks and applying problem solving skills to less routine and more complex tasks. Less supervision required and often only if requested by the Sr. Manufacturing Tech II. - Initiative into Action -- routinely incorporates planning ahead and identifying what might get in the way of completing tasks. Makes the connection between this competency and planning and begins to incorporate basic strategic thinking behaviors. - HS diploma with 6-8 yrs experience To apply for the position, please click here. Gilead is an equal opportunity employer. Location: Oceanside Principals only. Recruiters, please don't contact this job poster. Please, no phone calls about this job! Please do not contact job poster about other services, products or commercial interests.
    losangeles.craigslist.org   ...Read On



    Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and experimental drug candidate, we seek to improve the care of patients suffering from life-threatening diseases around the world. Our portfolio of 14 marketed products includes a number of category firsts, including the only complete treatment regimens for HIV infection available in a once-dailysingle pill -- Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), approved in 2006, and Complera?, approved in 2011. Sr Instrumentation Technician Specific Responsibilities Install, calibrate, troubleshoot, repair, and modify process control instruments or systems. Install, calibrate, troubleshoot, repair, and modify electronic, electromechanical, and pneumatic control devices for utility systems which support the manufacturing facilities. Perform calibrations and scheduled preventive maintenance on analytical and other laboratory instruments. Write calibration and equipment service reports. Write calibration and preventive maintenance Standard Operating Procedures. Test control systems and assist in validation of new and existing manufacturing facilities. Collect and organize technical data from equipment manufacturers, equipment users, and engineering personnel. Assist in preparation of engineering revisions. Assist with identification, purchase, and organization of spare parts. Interact with scientists, engineers, and production staff. Essential Duties and Job Functions Conduct diagnostics, repairs, and modifications of industrial process control instrumentation. Provide cGMP/cGLP documented calibration, repair and modification for process and analytical instruments used in QC laboratories, bio-manufacturing and related utilities. Assist manufacturing personnel in achieving and keeping maximum production efficiency. Prepare and organize technical documentation and operational procedures. Knowledge, Experience, and Skills Excellent verbal, written and interpersonal communication skills Ability to give formal presentations to internal and external audiences of various sizes Demonstrated experience in patient advocacy, media relations; knowledge of healthcare and industry media and reporting trends Demonstrated knowledge of regulations and principles specific to communications for a publicly-traded biopharmaceutical company Must have experience with public relations tactics and resources and the relationship of those tactics to other department roles and functions Experience managing multiple projects (timelines, budgets, priorities) simultaneously; flexibility is essential. Specific Education and Experience Must be proficient in ISA standards and practices for instrumentation. Thorough knowledge of PID control theories and techniques. Thorough knowledge of relay ladder logic and programmable controllers. Ability to read and interpret engineering drawings and specifications. Familiarity with computer-aided manufacturing automation and related communication hardware and software. Must have good oral and written communication skills. Must be able to work different shifts with minimal direct supervision. Completion of an Instrumentation or Industrial Electronics (2-year) curriculum at a technical school, or an AA/AS Degree in a related science or engineering major plus substantial relevant on-the-job training. 4 years in manufacturing process instrumentation and control and/or analytical instrumentation or a closely related job. Work Environment/Physical Demands/Safety Considerations Schedule may include a non-rotating 4-day (10 hour shift), one weekend day, evening or night hours, or full off-shift hours. Expected to be on feet for 8 to 10 hours a day. Climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility. Lift up to 25lbs may be required. Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. No make up or jewelry can be worn when working in the clean room environment. Work in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a loud environment. Work with hazardous materials and chemicals. To apply for the position, please click here. Gilead is an equal opportunity employer. Location: Oceanside Principals only. Recruiters, please don't contact this job poster. Please, no phone calls about this job! Please do not contact job poster about other services, products or commercial interests.
    losangeles.craigslist.org   ...Read On



    (The Company of Biologists) Hepatocellular carcinoma (HCC), the most common type of liver cancer, is a leading cause of cancer-related deaths worldwide. Few treatment regimens are successful, because the disease is complex and poorly understood. Zhiyuan Gong and Serguei Parinov from the National University of Singapore used a simple animal model -- the zebrafish -- to unravel new genetic clues as to how HCC could be more effectively diagnosed and managed in patients suffering from the disease.
    www.eurekalert.org   ...Read On



    Telaprevir-based triple therapy showed some promise against hepatitis C virus genotype 2 infection but had limited activity against genotype 3 infection.

    Recently, telaprevir received FDA approval for use in triple therapy to treat hepatitis C virus (HCV) genotype 1 infection. The new triple regimens — peginterferon, ribavirin, and a protease inhibitor — are more efficacious than combination therapy (peginterferon and ribavirin) in patients with such infection. Although patients with HCV genotype 2 (G2) or genotype 3 (G3) infection generally respond well to combination therapy, 20% to 30% do not attain a sustained virologic response (SVR).

    To evaluate the antiviral activity of telaprevir in treatment-naive adults with chronic HCV G2 or G3 infection, researchers conducted a phase IIa, manufacturer-sponsored, randomized, partially blinded study involving 23 G2-infected patients and 26 G3-infected patients.
    Participants received one of three regimens for 2 weeks:

    • Telaprevir 750 mg orally every 8 hours (monotherapy)
    • Telaprevir plus peginterferon alfa-2a 180 µg once weekly plus ribavirin 400 mg twice daily (triple therapy)
    • Placebo (every 8 hours) plus peginterferon and ribavirin
    Thereafter, all participants received peginterferon and ribavirin for 22 or 24 weeks.
    Among HCV G2-infected patients, SVR rates were 56% (5 of 9) with telaprevir monotherapy, 100% (5 of 5) with triple therapy, and 89% (8 of 9) with peginterferon plus ribavirin. However, among the HCV G3-infected patients, SVR rates were 50% (4 of 8), 67% (6 of 9), and 44% (4 of 9), respectively.

    Comment: In this small exploratory study, telaprevir-based triple therapy showed some promise against HCV G2 but had limited activity against HCV G3. These findings highlight the fact that although protease inhibitor–based HCV treatment regimens are superior to peginterferon plus ribavirin for treating genotype 1 infection, the same might not be true for treating infections caused by other genotypes.
    Atif Zaman, MD, MPH

    Published in Journal Watch Gastroenterology June 10, 2011

    Citation(s):

    Foster GR et al. Telaprevir alone or with peginterferon and ribavirin reduces HCV RNA in patients with chronic genotype 2 but not 3 infections. Gastroenterology 2011 Jun 1; [e-pub ahead of print]. (http://dx.doi.org/10.1053/j.gastro.2011.05.046)
    hepatitiscnewdrugs.blogspot.com


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