Amgen Jobshttp://www.amgen.jobs2012-05-27 00:55:15.521888USAThousand OaksAuto req 15650BR Job Posting Title Sr Mgr Biostatistics Career Category Research Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The Senior Manager Biostatistics will implement, oversee and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis •Plan and execute statistical contributions to Study Concept Documents (SCDs), protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph ( TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Data Quality Review (DQR), Flash Memos, Clinical Study Reports (CSRs), clinical publications, product plans (e.g. Global Development Plan), Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), regulatory documents, reimbursement documents and other communications •Complete statistical analysis of multiple studies/projects •Hire, manage and develop statistical staff •Contribute to resource and budget planning •Publish applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings) •Be familiar with statistical policy and strategy at Amgen •Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field •Promote and communicate statistical awareness and the role of the Global Biostatistics department, and may contribute to statistical consultancy, statistical training and expert advice within Global Biostatistics and within Amgen •Lead and/or participate in the development and review of Amgen Policies, SOPs and other controlled documents •Participate in study and systems audits conducted by Amgen CQA and external bodies, and respond to audit questions and findings •May lead and/or participate in change / process improvement initiatives •May participate in external activities (e.g. Industry, academic) Basic Qualifications .Doctorate degree & 2 years of directly related experience OR .Master’s degree & 6 years of directly related experience OR .Bachelor’s degree or & 8 years of directly related experience OR •Associate’s degree & 10 years of directly related experience OR •High school diploma / GED & 12 years of directly related experience AND . 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications Minimum 8 years relevant career experience in the pharmaceutical/biotechnology industry, with Bachelor’s degree (MS/MA degree preferred) in Biostatistics, Statistics, Computer Science, Mathematics, Life Sciences, or other relavent scientific subject Strong project planning and management skills - the ability to lead and manage cross-functional projects from concept to completion, being proactive and taking initiative, striking balance between strategic and tactical thinking, the ability to handle complex tasks, and deliver according to agreed timelines Strong verbal and written communication skills - ability to clearly and effectively present information, demonstrate creativity and foresight in anticipating and solving complex project issues Displays personal ownership - a natural innovator who is always looking for opportunities to improve systems or processes Track record of generating new ideas and solutions to business problems, and the vision and tenacity to translate that vision into quantifiable results Takes steps to ensure the ongoing technical development2012-05-08 18:44:22United StatesAmgenCalifornia15650BRCAThousand Oaks, CA28541377http://www.amgen.jobs/xml/28541377/jobUSAThousand OaksAuto req 15528BR Job Posting Title Principal Scientist - Cardiovascular Discovery Research Career Category Research Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. A new position is available in the Department of Metabolic Disorders at Amgen. The Amgen cardiovascular research group in Metabolic Disorders is looking for a highly motivated principal scientist with experience in biopharmaceutical discovery research and/or academic basic research to join them in their R&D facility in Thousand Oaks, CA. The successful candidate will have the primary responsibility of leading a large animal cardiovascular physiology laboratory, focusing on models of heart failure and arrhythmias. This individual must have strong technical skills in such models, and the candidate’s primary responsibility will be hands on implementation and critical interpretation of experiments required to assess compound efficacy using state of the art techniques and methods. The successful candidate must also possess the communication/managerial skills along with the level of expertise such needed to teach relevant techniques to less experienced colleagues and reports. The successful candidate will need to work effectively in a fast-paced environment, have the ability to multi-task and work effectively with multiple groups (internal and external to Amgen), have strong oral and written communication skills, and be self-motivated. This position will report directly to the Executive Director of the Cardiovascular Discovery Research Group at Amgen. Basic Qualifications Doctorate degree & 5 years of scientific experience OR Master’s degree & 12 years of scientific experience OR Bachelor’s degree & 15 years of scientific experience Preferred Qualifications The ideal candidate will have an MD or PhD in a scientific discipline, e.g,. physiology or pharmacology. A minimum of 5 to 10 years or more industrial experience in cardiovascular physiology using models of disease to interrogate the efficacy of therapeutic agents. Hands-on experience with canine models of heart failure and arrhythmias in support of early and late stage preclinical drug discovery projects is highly desirable. The ideal candidate will specifically have hands-on experience with cardiovascular imaging techniques (e.g. echocardiography) and invasive assessment of cardiovascular hemodynamics in large animals. The ideal candidate will also have excellent communication and teaching skills required to head a small group of scientists working interactively within a highly matrixed research environment.2012-05-04 19:32:51United StatesAmgenCalifornia15528BRCAThousand Oaks, CA28441231http://www.amgen.jobs/xml/28441231/jobUSAThousand OaksAuto req 15148BR Job Posting Title Sr Mgr Biostatistics Career Category Research Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description •implement, oversee and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis •Plan and execute statistical contributions to Study Concept Documents (SCDs), protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph ( TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Data Quality Review (DQR), Flash Memos, Clinical Study Reports (CSRs), clinical publications, product plans (e.g. Global Development Plan), Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), regulatory documents, reimbursement documents and other communications •Complete statistical analysis of multiple studies/projects •Hire, manage and develop statistical staff •Contribute to resource and budget planning •Publish applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings) •Be familiar with statistical policy and strategy at Amgen •Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field •Promote and communicate statistical awareness and the role of the Global Biostatistics department, and may contribute to statistical consultancy, statistical training and expert advice within Global Biostatistics and within Amgen •Lead and/or participate in the development and review of Amgen Policies, SOPs and other controlled documents •Participate in study and systems audits conducted by Amgen CQA and external bodies, and respond to audit questions and findings •May lead and/or participate in change / process improvement initiatives •May participate in external activities (e.g. Industry, academic) Basic Qualifications .Doctorate degree & 2 years of directly related experience OR .Master’s degree & 6 years of directly related experience OR .Bachelor’s degree or & 8 years of directly related experience OR •Associate’s degree & 10 years of directly related experience OR •High school diploma / GED & 12 years of directly related experience AND .2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications Minimum 8 years relevant career experience in the pharmaceutical/biotechnology industry, with Bachelor’s degree (MS/MA degree preferred) in Biostatistics, Statistics, Computer Science, Mathematics, Life Sciences, or other relavent scientific subject Strong project planning and management skills - the ability to lead and manage cross-functional projects from concept to completion, being proactive and taking initiative, striking balance between strategic and tactical thinking, the ability to handle complex tasks, and deliver according to agreed timelines Strong verbal and written communication skills - ability to clearly and effectively present information, demonstrate creativity and foresight in anticipating and solving complex project issues Displays personal ownership - a natural innovator who is always looking for opportunities to improve systems or processes Track record of generating new ideas and solutions to business problems, and the vision and tenacity to translate that vision into quantifiable results Takes steps to ensure the ongoing technical development2012-04-17 20:12:41United StatesAmgenCalifornia15148BRCAThousand Oaks, CA27953376http://www.amgen.jobs/xml/27953376/jobUSAThousand OaksAuto req 15158BR Job Posting Title Scientist - Chemical Process Research and Development Career Category Research Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description A Scientist in the CPR&D Department (Chemical Process Research and Development) is responsible for development of the technology enabling manufacture of Amgen’s drug substance candidates from pre-clinical to commercial scales. The Scientist will participate in drug substance development teams and be expected to develop innovative solutions to prepare Amgen drug substances. KEY RESPONSIBILITIES*: SCIENTIFIC/TECHNICAL • Develop technology to deliver Amgen’s API candidates in a practical, efficient and safe manner. • Participate in drug substance teams and collaborate cross-functionally with analytical and drug product representatives to delivery drug substance manufacturing processes in a phase appropriate manner. • Work cross-functionally to deliver CMC regulatory documents and supporting documentation in support of Amgen’s small molecule regulatory filings. • Work with external partners to deliver key intermediate or drug substances in support of Amgen’s small molecule pipeline. • Deliver processes amenable to cGMP operation and carry out deliveries of drug substance in a cGMP manufacturing environment. TEAM EXPERIENCE • Demonstrates ability to effectively participate on drug substance development teams as a team member or primary department representative • Represents the department in various departmental and interdepartmental committees that address scientific and administrative initiatives • Participates in and can direct team efforts directed at advancing development/technology programs within the department • Applies team experiences to facilitate cohesiveness and build team spirit ORAL AND WRITTEN COMMUNICATION • Authors, or provides direction for the authorship of, technical reports or regulatory submissions which may require minimal additional editing. • Gives effective presentations within the department and to senior management with minimal supervision. • Actively creates, generates, and presents paper/presentations at scientific meetings. • Capable of organizing and conducting effective meetings. • Learns and applies facilitation and listening skills. SUPERVISING OTHERS [MAY HAVE DIRECT REPORT(S)] • Ensures that safe laboratory practices are followed. • Trains less-experienced staff. • Demonstrates ability to direct the activities of others. LEADERSHIP AND INFLUENCE • Identifies resources and develops timelines for project activities. • Learns to organize, plan, and control multiple project activities effectively to meet corporate timelines. • Effectively and actively participates on one or more project team with demonstrated ability to occupy a leadership role. Basic Qualifications • Master’s degree & 4 years of scientific experience OR • Bachelor’s degree & 6 years of scientific experience Preferred Qualifications • Ph.D. in Organic Chemistry and 0-5 years of relevant experience in the pharmaceutical or related industry which includes participation and contribution to scientific project teams • A BS Scientist with a minimum of 10+ years pharmaceutical industry or MS scientist 8+ years of relevant experience in the pharmaceutical or related industry which includes participation and contribution to scientific project teams. • Experience with the techniques associated with the synthesis, purification and characterization of organic molecules • Experience with protein expression in E. coli and intein or sortase technology • Experience with large molecule purification techniques • Experience with synthetic organic techniques applied to peptides • An scientific track record which may include peer reviewed publications, scientific conference participation • Experience with the use of analytical instruments (HPLC, NMR, IR and MS) and interpreting the scientific data based upon these techniques. • Demonstrated communication and scientific writing skills.2012-04-06 21:47:28United StatesAmgenCalifornia15158BRCAThousand Oaks, CA27706681http://www.amgen.jobs/xml/27706681/jobUSAThousand OaksAuto req 13954BR Job Posting Title Scientist Career Category Research Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the globe, Amgen fosters an inclusive environment of diverse, committed and highly accomplished people. People who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. We are currently seeking a Scientist for our Clinical Immunology group. This role will: • Design and execute specific scientific experiments for development, validation and implementation of methods capable of detecting anti-drug neutralizing antibodies or for measurement of drug biological activity in clinical and nonclinical study samples • Develop and implement new and novel protocols to address specific issues and/or troubleshoot and improve currently existing assays towards being more sensitive, transferable, and high-throughput • Conduct data analysis and interpretation, and assesses impact of the data on the project • Provide technical support and expertise to department operating groups when needed • Represent the department on cross-functional project teams • Provide scientific oversight to transfer of assays to CROs • Assist senior-level Scientists in managing clinical and/or non-clinical programs • Contribute as lead author on scientific documents such as journal publications, technical reports, etc. Basic Qualifications Doctorate degree OR Master’s degree & 3 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience Preferred Qualifications A successful candidate in this role should: • Post doc experience preferred • Demonstrate innovation in cell signaling, in vitro assay design • Be able to solve complex problems demonstrating a deep understanding in a scientific area of expertise. • Demonstrate ability to drive scientific excellence and innovation. • Knowledge of the drug development process • Have the ability to effectively present scientific information both internally and externally to influence decisions and/or scientific practices • Demonstrate knowledge of the IND/NDA process • General knowledge of the field of Immunology, Oncology, Immunochemistry, or Cell Biology and pertinent immunologic assays. • Experience in in vitro cell-based assays and related technologies, in-depth knowledge of signal transduction processes. • Development, validation, transfer and implementation of assays detecting and characterizing antibodies to protein products in biological matrices and/or measuring drug activity. • Development, validation, transfer and implementation of fluorescence-based assays in cell lines, animal model and/or human specimens in collaboration with analysts and scientists in a variety of clinical / therapeutic areas. • Project Management as it pertains to oversight of vendors, assay transfers and implementation of outsourced assays. • Ability to communicate complex ideas to audiences with varying degrees of knowledge • Initiative • Attention to detail • Independence of thought demonstrated through hypothesis formulation, experimental design, interpretation and innovation • Demonstrated critical thinking with an ability to integrate data and information to solve complex problems • Ability to collaborate on a functional and/or cross-functional team as a leader and/or a member • Ability to build and manage a team2012-02-17 19:39:09United StatesAmgenCalifornia13954BRCAThousand Oaks, CA26597026http://www.amgen.jobs/xml/26597026/job