DNAjobs.com is proud to feature the following jobs posted May 8 - 15 (listed in chronological order). For each position, I have listed a short description and a link for more information.
As always, I wish you tremendous success in your searching!
Jason
Vice President - R&D ( Bulk Drugs / API )
(India) Candidate should have lead a large team/teams of at least 40-50 persons working on different projects and should have hands on exposure to generic research,process development. Exposure to NCEs work is desirable.
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Director of Drug Safety
(US-Massachusetts) The Director is responsible for all activities related to the monitoring and reporting of the safety profile of marketed products on an ongoing basis. This includes the management of potential risks associated with these products, ensuring compliance with FDA regulations on expedited and periodic reporting of Adverse Events, developing and adhering to Corporate Standard Operating Procedures (SOP).
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Manager Drug Safety
(US-Massachusetts) Manage the processes and reporting of adverse events (AE) of marketed products and products under development while assuring compliance with regulatory requirements and internal SOPs. Responsibilities also include the management and oversight of Drug Safety Associates and their roles for adverse event report processing.
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Clinical Program Manager
(US-Massachusetts) The (Sr) Clinical Program Manager works within the Department of Clinical Operations to manage clinical studies that are designed to establish the safety and effectiveness of Company's products. This person initially will focus on early clinical development, but will have the ability to bring one or more of these products to Phase III development, as necessary.
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Clinical Project Manager
(US-Massachusetts) Responsible for managing the development, initiation, conduct, monitoring and completion of clinical studies. Provide operational perspective to planning of clinical studies. Generate timelines for initiation to completion and reporting of clinical studies.
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Senior Clinical Research Associate
(US-Massachusetts) Working independently, under minimal supervision, the Senior Clinical Research Associate will be responsible for all operational aspects of implementation and conduct of clinical studies including study planning, implementation, monitoring and completion activities. A travel commitment will be required.
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Group Leader-Cancer Biology
(US-Massachusetts) Join a team of leading researchers at one of the world's premier biotechnology Companies. Currently, this Company is expanding their research program in Signal Transduction-Based Drug Discovery in Molecular Oncology and Cancer Biology.
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Sr Validation Engineer
(US-Tennessee-Memphis) 8 yrs plus Validation experience in the biotechnology or pharmaceutical industry. Experience with cGMP environment including mfg, utility and automation systems. Validation principles, mfg processes, quality systems, eng design fundamentals, regulatory agency expectations and industry trends.
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Principal Scientist
(US-New Jersey) This position is focused on cell biology related to the treatment of diabetes. Experience with developmental and stem cell biology relevant to diabetes is required. Job responsibilities include conducting and managing in vitro and in vivo experiments.
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Field Application Specialist
(US-California-San Francisco) A leading supplier for genomic and proteomic research and R&D services for the Biopharmaceutical industry is looking for a results oriented Key Account Sales professional. Salary is base between $45-50K to start, commissions up to 20% of your salary, with some bonus/incentives for going over plan.
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Field Application Specialist
(US-Massachusetts-Boston) A leading supplier for genomic and proteomic research and R&D services for the Biopharmaceutical industry is looking for a results oriented Key Account Sales professional. Salary is base between $45-50K to start, commissions up to 20% of your salary, with some bonus/incentives for going over plan.
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Staff Development Supplier Engineer
(US-California-Silicon Valley/San Jose) The LifeScan Manufacturing Department is looking for candidates to: carry out complex or novel assignments requiring the development of new or improved techniques or procedures; make independent decisions on technical problems and methods; and serve as a technical specialist in the area of reagent raw chemicals.
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Manager of Biostatistics / Biostatistician
(US-Pennsylvania-Philadelphia) PROVIDE STATISTICAL EXPERTISE AND LEADERSHIP FOR THE COMPANY THROUGH INVOLVEMENT IN ALL STATISTICAL DISCUSSIONS, TASKS AND DECISIONS RELATING TO CLIENTS AND INTERNAL PROJECTS. REVIEW IVRS RANDOMIZATION MODULES DESIGNS.
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Plant Manager
(US-Missouri-St. Louis) Plans, directs, coordinates and manages plant operations within the scope of objectives and policies established by corporate management. Responsible for operational results of the plant. Ability to multi-task and meet or exceed tight deadlines Demonstrated problem-solving skill through difficult and complex problems.
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Vice President-Medical Director
(US-Massachusetts) Your responsibilities will be numerous in this hands on position. Two (2) positions exist! You will report to, and work closely with the Sr. Vice President of Medical Affairs to plan, direct and oversee clinical studies intended for FDA and foreign regulatory submission.
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Regulatory Affairs Manager
(US-Massachusetts) Responsible for the management of regulatory activities in the support of external commercial communications, labeling development, and labeling maintenance. This person represents regulatory in cross-functional teams that review and/or approve promotional materials, sales training materials, press materials, and other external communications.
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Regulatory Affairs Manager
(US-Massachusetts) Reporting to the Associate Director of Regulatory Affairs, the Manager will be responsible for determining Regulatory strategy for specific projects relating to the development of new formulations, new delivery systems and new indications for commercial products as well as post-marketing commitments and Phase 4 studies.
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Vice President -Regulatory Affairs
(US-Massachusetts) Anticipate consequences and assess impact of new or revised worldwide regulations and guidelines on the company’s strategies. Review and approve key segments of regulatory submissions. Represent the company and effectively participate with senior level representatives of regulatory agencies worldwide.
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Sr. Quality Control Microbiologist
(US-Massachusetts) Responsible for all microbiological and some analytical testing of production materials under GMP conditions. Responsible for process and equipment validation (autoclave and depyrogenation oven) in cooperation with Engineering and R&D (New Product Sterility and LAL validation).
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Sr. Quality Assurance Specialist
(US-Massachusetts) The qualified candidate will assist in the routine performance of Quality Systems to assure compliance with in-house specifications, standards and cGxPs, with an emphasis on auditing, documentation, data review and training.
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Research Scientist Trainees - Chemical Process Development
(India) Dynamic, motivated and research oriented fresh Ph.D.'s having extensive research & development training in Synthetic Organic Chemistry/Medicinal Chemistry with a consistent excellent academic record from High school (10th) onwards, preferably a throughout first class.
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Research Scientist - Product Development
(India) Experience: 2 years plus experience especially in the field of parenteral controlled drug delivery. Fresh PHDs from good universities could also be considered. Qualifications: The candidate should have a Ph.D. degree in Pharmaceutics.
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QA Professional
(US-California) In addition to responsibility for day to day operational quality support for investigational and marketed products, the successful candidate will take the lead on health authority inspections, serve on critical quality teams, oversee contract manufacturing operations, and represent the QA organization to other internal departments.
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Clinical Research Specialist
(Netherlands) Main tasks: Provides study management and assures successful conduct of assigned clinical programs; determines study objectives, strategy, scope and schedule in order to meet business needs; develops and executes the Investigational Plan; provide/coordinate technical support at the investigational sites.
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Manager Clinical and Regulatory Affairs
(Netherlands) The Manager Clinical and Regulatory Affairs (MCRA) is responsible for the registration of products in the EU and US, the gathering of clinical evidence for product registration as well as to ensure that the Product Development process is conducted so that commercialization of products is feasible.
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Account Representative
(US-Texas-Houston) This person will be responsible for actively growing sales and profits by utilizing direct customer contact to increase sales. Will also build long term relationships with customers, and work in conjuction with the rest of the team to achieve sales goals.
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DNA Lab Supervisor
(US-Texas-Houston) Supervise production technicians and provide direction for daily tasks. Insure functions are completed to meet guidelines. Must have strong interaction with all levels of employees. And provide comprehensive training. Insures all processes are completed in accordance with SOP and ISO standards.
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Sales Director Europe
(London/ Geneva) The major responsibility of this position will be to grow European sales and market share in the Central Labs businesses without compromising product margins. The European Sales Director will also be responsible for making sure the strategic marketing plan for Europe is fully implemented by the selling organization.
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Senior CRA
(Netherlands) Perform site management according to regulatory requirements and internal SOPs/policies. Cooperate with data management to resolve queries and adhere to data cleaning targets. Understand and implement safety-reporting process.
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Experienced CRA
(Germany) Perform site management, including pre-study site evaluation, regulatory document collection, site initiation and monitoring and close out in conformance to all relevant regulatory requirements and internal SOPs/policies. Cooperate with data management to resolve queries and adhere to data cleaning targets.
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Business Development Manger
(France) The successful candidate will have a minimum of 5 years of business development experience acquired in a research-based pharmaceutical industry or biotech industry, and have a thorough understanding of pharmaceutical research and development projects.
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Head of Chemistry
(France) The position requires a highly motivated scientist with a documented record of productivity in the areas of design of biologically active molecules and synthetic chemistry and an understanding of state-of-the-art chemical information systems.
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Director of Bioanalytical Methods Development
(US-North Carolina-Raleigh/Durham-RTP) Direct, manage and participate in the development, qualification and validation of analytical and bioanalytical methods used for product characterization, process development and QC in-process and release tests for viral vaccine clinical supplies.
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Director of Formulation and Process Development
(US-Ohio-Cincinnati) The Director of Formulation/Process Development will establish appropriate laboratory practices that assure development studies are conducted to regulatory standards in support of client programs. The successful candidate will also direct the development effort of the department staff to meet program timelines, quality standards, and budget targets.
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Clinical Trials Account Representative
(US-Minnesota-Mankato/Rochester) We are seeking an innovative and motivated Clinical Trials Account Manager to sell the services their research division has to offer clients worldwide. Your role? Expand a current customer base as well as establish new business in the field of clinical research.
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Cheminformatics Management and Support, Europe
(UK-London) The successful candidate will have the following characteristics: At least three years of management experience; Computational chemistry or cheminformatics background (Ph.D. preferred); Scientific software support experience; Ability to get things done quickly, successfully, and with the big picture in mind.
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Senior Biostatistician
(US-Ohio) Senior Biostatisticians oversee the development, progress, accuracy, and timely completion of research projects. They also plan, analyze, review, interpret and summarize the statistical component of research projects.
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Quality Assurance/ Regulatory Affairs Manager
(US-California-San Diego) A leading biotech company has an opening for a Quality Assurance/Regulatory Affairs Manager. This highly visible position will report to the COO and be responsible for all activities involving quality assurance and compliance with applicable regulatory requirements.
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Clinical Research Manager
(US-Massachusetts) Do you have a PhD or a PharmD? Have you managed clinical trials related to metabolism (obesity, lipid disorders, diabetes)? Do you have early clinical development experience (Phase 1, 2)? If you have answered YES to these 3 questions, we look forward to discussing this opportunity with you.
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Regulatory Affairs Manager
(US-California-Los Angeles) We are seeking a manager for our Regulatory Affairs department. Applicants should have a degree in chemistry or related discipline and a minimum of 5 years of RA experience in a pharmaceutical environment.
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