CURRENT PRIORITIES Director of Clinical Management: Supervising 40 people, in So, California.  Clinical Trainning Manager: Establish and maintain clinical SOP's and provide clinical training in all areas clinical research. Director, International Drug Safety Associate Director of International Regulatory Affairs: London and Midwest U.S.  Manager, Medical Dictionary, Adverse Events. Sr. Coder for Medical Dictionary Applications. Sr. Medical Writer: NDA. Associate Director of Market Research: New drug product launch next year.  Sr. Regulatory Affairs Associate: NDA, Biologics.   OTHER OPENINGS [ Clinical Research Associate ] The candidate will be able to manage clinical sites and be able to assist in the development of protocols, case report forms, and informed consents, according to GCP, ICH, and company SOPs. The candidate will perform site initiations, monitoring visits, handle contract negotiations, and sponsor-client communications. The candidate should have experience in performing site evaluation, initiation, monitoring, and termination visits, and have experience with data collection, source verification, drug accountability, and maintenance of regulatory files. Position requires a minimum of 3 years of prior CRA experience. The candidate should have strong verbal, written, and interpersonal skills, and have a good understanding of FDA regulations, GCP, and ICH guidelines. Able to travel 30% to 70% as the need arises. Bachelor's degree in biological sciences, nursing, pharmacy or related fields.                 Associate Medical Director This is a new position for Aranesp Oncology that will be responsible for the development and maintenance of relationships with key opinion leaders (KOL) in the oncology community. This incumbent will represent Amgen to the medical, regulatory, and academic community. Responsibilities include but are not limited to: update KOLs and solicit opinions regarding future clinical strategy, develop and maintain a speakers’ bureau, develop and implement the strategy for investigator initiated and cooperative group clinical studies, develop relationships with all of the key committee chairs as well as other KOLs within the cooperative groups. Other duties include contributing to the overall clinical development plan, representing the medical scientific perspective of the therapeutic area, and updating key internal liaisons regarding clinical developments. The candidate will make scientific presentations to significant scientific bodies, professional societies and foundations. Must have M.D. or an M.D. Ph.D., preferably Board Certified in hematology and or oncology and three years of pharmaceutical experience and or outstanding academic career. Candidates with a Ph.D. and significant clinical expertise will be considered.                   Director, Indirect Material Sourcing This is a leadership position managing Indirect Sourcing activities within the Strategic Sourcing & Procurement organization. Responsibilities include: Develop and execute sourcing group goals, objectives and action items, manage strategic client relationships and communicate/market the capabilities of the organization to internal and external audiences, develop risdk management strategies, assist with identification and development of knowledge management training activities and champion continous improvement programs. Requirements include 10-12 years of Procurement experience in the healthcare (or related) industry, with a minimum of 8 years in a leadership role), and an MBA or equivalent.                   Clinical Affairs Responsibilities:Identify clinical investigators for site evaluation; recommend clinical investigators for study placement; develop recruitment strategies with the investigator and investigative staff to meet enrollment; contribute to the preparation and feasibility of clinical protocols, case report forms, informed consent and subject instructions and study guides; contribute to the preparation of Monitoring Plans; identifies potential investigators for future clinical studies in assigned region; assist in the development of study budgets; contribute at Investigator MeetingsExperience:Typically 6 years related experience in life sciences, including 5 years as a CRA in the biopharmaceutical industry; general therapeutic area education and training, eg, nursing, medic; previous experience as a Regional CRA in the biopharmaceutical industrySkills:Demonstrated ability to work independently in a regional area; knowledge of informed consent process; experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations; experience with development of prospective site-selection criteria; detailed knowledge of FDA regulations and guidelines; familiar with interpretations and experience enforcing at site independently and consistently; experience in developing and administering study budgets and negotiating at sites with occasional supervision; ability to maintain a problem-solving attitude while dealing with time demands, incomplete information or unexpected events; able to influence investigative staff in a positive manner; experience in interactions with outside vendors, e.g., CROs and contract labs; experience with responding to findings of a CQA or regulatory site or sponsor auditEducation:BA/BS in biological sciences or related field, or RN (M.S. or Pharm.D. preferred)  Sr Biotatisticians  Conducts statistical analysis and prepares statistical reports for clinical trials phases 1-4 including randomization, sample size estimation. Reviews protocols and provides statistical guidance, prepares statistical analysis, plans and analyzes data subsets. Supports regulatory filings, makes hiring recommendations and acts as a Biostatistic's team leader. Creates and modifies programs to review or summarize data and provides input on study designs. Typical years of experience are three plus years for a Biostatistician II and 5 plus years for a Sr. Biostatistician. Statistical programming skills using SAS, basic knowledge of clinical research methodology and FDA regulations. Ms.Sc or Ph.D. in Biostatistics or related field   Clinical Data Management  Individuals in this position will implement and execute all clinical data review activities for clinical studies in a specified area. In addition, they will provide leadership in implementing electronic data review tools to assist in their review. Responsibilities include: Developing, implementing and maintaining Data Management Plans and electronic edit checks; performing data review; and finalizing databases for analysis. Four years experience in a related medical or research setting including two years in clinical data management. Experience with databases and using electronic tools to perform database queries; Familiarity with FDA regulations pertaining to data quality and clinical trials. B.A. or B.S. in the Sciences, or an equivalent combination of education and experience. Research Associates  Positions for Research Associates include but are not limited to Cancer Biology, Pharmaceutics, Protein Chemistry, Immunology and Neuroscience. The following description is for an Associate in the Small Molecule area: Job Responsibilities: This position will require an individual to participate in a research program to develop cancer therapeutics. Experience: The qualified candidate will have solid molecular and cellular biology skills, and at least four years of experience working in a productive research laboratory. Experience and knowledge in cancer biology is preferred. Necessary Skills: The necessary skills include cDNA manipulation, cloning, subcloning, PCR, Western blotting, and cell culture. A solid understanding of molecular and cell biology concepts is essential. Education: Candidates must have a Bachelor's degree in biology or a related field.   Research Scientist II/III  Design, conduct & interpret experiments to characterize the physicochemical properties of small molecule clinical candidates. Develop early stage solid dosage formulations to support PreClinical (Tox, PCOL, PK/DM) and Research activities. Supervise others engaged in these activities and participate on various project teams. 3 - 7 years solid hands on industrial experience. Experience in analytical methodology, conducting solution & solid state studies, salt selection, studying polymorphism and working with chiral compounds and solid dosage forms. Versed in GLP/GMP and compiling CMC data for regulatory submissions. Expertise in analytical chemistry techniques, such as HPLC, TGA, DSC, IR (FT and/or Raman), microscopy, KF analyzers, optical rotation, surface tension, X-Ray powder diffraction, NMR. Comprehensive knowledge in conducting solubility studies, pKa determinations, kinetic studies, degradant identification, excipient compatibility and API stability. Ph.D. in Physical Organic Chemistry, Pharmaceutical Chemistry, Pharmaceutics or related field.  Research Scientist I/II  Responsibilities will include adopting novel technologies to develop rapid and precise cell-based bioassays. The position requires knowledge and expertise in the mechanism of action of cytokines and growth factors, including protein kinase mediated signal transduction. A strong working knowledge of techniques and approaches in cell biology and molecular biology is required. Prefer knowledge of: Cell-based bioassays in biotechnology or pharmaceutical setting, receptor-ligand binding, HTRF, FLIPR, Flow Cytometry and biosensor technology. May supervise one or more Research Associates. The position requires a PhD in biochemistry, cell biology or related field with 3+ years of relevant postdoctoral research experience and publications in peer reviewed journals. Research Associate II/III  Initiate and perform experiments using Biosensor technology to characterize protein-protein interaction, ligand-receptor binding, antigen-antibody affinity with minimum supervision. 3+ years of lab experience with 1 year of BIAcore experience required. Experience with Origen analyzer and HPLC/FPLC desirable. Competence with BIAcore 1000 and/or 2000 and computers with good kinetics analysis skills. Bachelors degree in Life Science or a related field or equivalent. Research Scientists  Positions for Research Scientists include but are not limited to Protein Chemistry, Pathology, Cancer, Pharmaceutics and Analytical R & D. The following description is for an Scientist in the Small Molecule area: Job Responsibilities: The individual will be responsible for initiating and conducting applied research to develop cancer therapeutics. The position requires knowledge and expertise in the molecular genetic aspects of tumorigenesis, preferably in one of the following areas: cell cycle control, apoptosis, growth control mechanisms, cell/cell interactions or tumor suppresser genes. Education: Candidates must have a Ph.D. and 2-4 years of postdoctoral training in a related field. Excellent academic credentials are preferred. Systems Analyst II/III  The Systems Analyst is responsible for providing support to the various Amgen product teams using Oracle Clinical as the clinical trials database. The System Analyst assists the Clinical Data Management Team Leaders and other members of the product teams in the creation and maintenance of the CTDB. Additionally, the Systems Analyst assists in the training of new staff in the use of Oracle Clinical. At least 3-6 years of related experience in the life sciences including 1-3 years in clinical data management in the pharmaceutical, biotechnology, or medical device industries  Process Development Associate - Protein  This position will be responsible for designing and implementing purification processes for both pilot and production-scale recovery of recombinant therapeutic proteins. The successful candidate will work as part of a team, interacting extensively with staff from areas such as Research Fermentation, Process Engineering, Manufacturing, Formulation and Regulatory. The requirements for this position are a Bachelor's degree in Biochemistry or related field plus typically 3+ years related industry experience in biotechnology. A thorough understanding of protein chemistry is essential, as is purification scale-up. In-depth knowledge of column chromatography and other recovery unit operations such as centrifugation, filtration, and protein refolding is also required.   QA Specialist I  Disposition product manufactured at Contract Manufacturing (CM) sites. Represent Quality Assurance as the Quality Unit contact with the assigned Contract Manufacturer. Represent Quality Assurance as the primary contact between CM Operations and Quality Control. Timely review of contract manufacturing batch records ensuring cGMP compliance, including investigations as related to small molecule manufacturing Active Pharmaceutical (APIs), solid oral dosage forms (drug product) and associated packaging operations. Monitor the cGMP performance at assigned Contractors. Participate in the audit program (contract manufacture site, report writing, and follow-up) for API, drug product and packaging operations. Experience is typically seven to ten years of related experience in a quality assurance, quality control or manufacturing environment in the pharmaceutical industry. Bachelor's degree in Life Science or related field. Project Associate II/III Summary: Perform duties and responsibilities in support of small molecule Quality Assurance program under minimal supervision in one or more of the following areas. Job Responsibilities: 1. Timely and accurate review of contract manufacturing batch records ensuring cGMP compliance, including investigations as related to small molecule Active Pharmaceutical (APIs), solid oral dosage forms (drug product) and associated packaging operations. 2. Communicate with and assist contract manufacturers regarding manufacturing batch record compliance issues. 3.Coordinate and facilitate quality investigations related to contract manufacturing. Tracks and follows up on investigation until report is generated and investigation is closed. 4. Participate in the audit program (contract manufacture site, report writing, and follow-up) for cGMP API, drug product and packaging operations. 5. Develop and review pertinent SOPs protocols as required. 6. Development product team participation support. 7. Perform administrative functions as required. 8. Perform special projects assigned by manager. Travel: 20-30% Experience: Typically 3-5 years or more small molecule pharmaceutical quality or a combination of quality and manufacturing experience. Education: Bachelor's degree in Life Science (biology, chemistry, biochemistry, microbiology) or related field.  Proc Dev Eng I/II  The successful candidate will work as part of a multidisciplinary team, with the Research, Formulation, Manufacturing and Regulatory to provide services for the startup and operation of the cGMP kilo-lab in the small molecule process development group. Experience in cGMP documentation, equipment startup and qualification and pilot plant operations is required. Other duties include reviewing laboratory protocols, preparation of batch sheets, designing and scaling-up experiments with chemists. The candidate should also provide technical support as well as troubleshooting in scale-up operations. The ideal candidate should have a BS/MS in Chemical Engineering or equivalent with 2-5 years experience in the Pharmaceutical or Biopharmaceutical industry. Proc Dev Eng II/Sr.  The responsibility of this position is to work on individual and team projects in the Formulation Process Development area, providing technical support for the production of recombinant-DNA-derived proteins deviations. The candidate must have at least seven years of experience in the area of biopharmaceutical process development. Experience in providing technical support for protein formulation lyophilization fill finish activities, and knowledge of cGMPs is required. Knowledge of protein stability issues in a variety of bioprocessing environments including freeze-drying and freeze-thawing, as well as experience in aseptic processing and process validation is required. B. S. or M. S. in Chemical Biochemical Engineering or equivalent.