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Company Jobs - MedImmune


 

Associate Scientist II / Scientist I, Virus Process Development

Gaithersburg MD

Education: For Associate Scientist II: * M.S. degree in cell biology, immunology or related discipline plus 5-8 years industry experience, * B.S. degree in one of the above areas plus 8-10 years industry experience. For Scientist I: * Ph.D. in chemical engineering, biochemistry, bioengineering, cell biology or related discipline for 0-3 years, * M.S. degree in one of the above areas plus 8-10 years commensurate industry experience, * B.S. degree in one of the above areas plus 10-13 years commensurate industry experience. Position: * Key emphasis will be given to individuals who have had a strong interest and background in chemical engineering and experience with non-fed-batch production bioreactor process development, with special focus on virus-based processes. * A strong background in metabolic engineering and an innovative approach to novel fed-batch process development. * Interest in automation and process integration is an important need for this position. * Excellent laboratory skills. * Must maintain accurate records of data, equipment calibration, equipment logs and actively participate in laboratory organization. * Professionally deliver experimental plans and results, possess excellent writing and communication skills, show critical thinking and attention to detail to support the preparation and review of documents and presentations. * Working in a collaborative -- will be close interaction with several groups inside MedImmune including other process development teams, process biochemistry (purification), and analytical biochemistry, MedI-Cambridge, as well as with other companies through R&D and technology collaborations. * Must have the ability to work with individuals from multiple technical areas and with varying levels of scientific and technical expertise. * Must have solid understanding of cell culture development principles including medium design, feed strategies, cell biology, biochemistry, bioreactor operation and control, and scale-up / scale-down principles. * Must also have strong written and verbal communication skills. * Experience working on vaccines and viruses in a process development setting including technology transfer to GMP * Knowledge of other areas on biopharmaceutical process development -- purification, formulation, analytical methods. * Good knowledge of small scale purification and analytical experience will be a plus as there may be a need to develop research protocols in purification and analytical methods to support molecule process development. * Track record of delivering innovative solutions to enable non-mAbs production using non-fed-batch approaches * Leadership in a laboratory environment and strong experimental design, statistical and data analysis skills * Publications in peer-reviewed journals . Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Additional Notes Req ID 9545 Position Category Development - Process Cell Culture and Fermentation

Posted On - 5/29/2015 7:26:17 AM

Operations Associate

Gaithersburg MD

Position: * 2+ years experience in word processing, preferably in the biotechnology or pharmaceutical industry. Includes proficiency in the use of Microsoft Office applications (2003/2010) with demonstrated advanced skills and expertise in Microsoft Word (templates and style usage) and Adobe Acrobat Professional. Experience with ISI Writer and ISI Toolbox and working knowledge of EDMS environments is a plus. Education: Requires an undergraduate degree or higher, preferably in a scientific discipline, or equivalent work experience. Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Additional Notes Extremely high attention to detail. *Ability to work collaboratively. Strong written, verbal, and interpersonal communication skills. *Ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment. Flexible/willing to adapt to changing deadlines and priorities. Req ID 9533 Position Category Medical Writing

Posted On - 5/29/2015 7:26:16 AM

Post Doctoral Fellow, Mechanisms of Sjogren's Syndrome

Gaithersburg MD

Education: PhD in Immunology or related discipline Position: * Well versed in the field of Immunology and autoimmunity * Understanding epithelial cell biology a plus * Strong hands on in vivo skills are required * In vitro cell based assay understanding, development and execution required * Background in mouse T cell and B cell immuno-assays. * Background in multi-color flow cytometry a plus * Understanding, development and execution of immuno (ELISA) based assays required and ELISPOT a plus * Experience in immunohistology a plus * Knowledge/handling of human blood and lymphocytes a plus * Able to work independently Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Req ID 9552 Position Category Research - Respiratory, Inflammation and AutoImmune

Posted On - 5/29/2015 7:26:16 AM

Senior Clinical Documents QC Specialist

Gaithersburg MD

Position: *2+ years experience in the medical writing or regulatory submissions field preferred. Includes proficiency at QC review of scientific, medical, or clinical documents/reports and working knowledge of EDMS environments. Proficiency in the use of Microsoft Office applications. Extremely high attention to detail. Education: *Requires a bachelor's degree or higher, preferably in a scientific discipline, or equivalent work experience. Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Additional Notes *Ability to work collaboratively. Strong written, verbal, and interpersonal communication skills. *Ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment. Flexible/willing to adapt to changing deadlines and priorities. Req ID 9538 Position Category Medical Writing

Posted On - 5/29/2015 7:26:16 AM

Maintenance Planner

Frederick MD

Position: Thorough understanding of SAP CMMS General understanding of logistics theory and concepts General understanding of procurement theory and concepts At a minimum, 5 years experience in a GMP facility with experience in inventory control, record keeping and filing, project management, maintenance planning and scheduling Education: Associates degree with 2 years relevant experience, or High School diploma or GED and 5 years of job related experience *LI-MEDI Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Additional Notes Demonstrated ability to adhere closely to all company Standard operating Procedures at all times, adhere to schedules, interface in a constructive manner with associates, peers and managers. Must be able to work in a fast-paced environment and be well organized Demonstrated capabilities in the areas of: Utilizing computerized maintenance management systems (CMMS) Maintaining equipment and systems data files Providing "inspection ready" records Excellent written and verbal communication skills Proficient in computer skills and MS Office applications Req ID 9559 Position Category Engineering & Facilities

Posted On - 5/29/2015 7:26:16 AM

Field Reimbursement Manager (San Antonio, TX)

San Antonio TX

Position: Job Requirements: * Compliance, Knowledge, & Skills * Does not compromise ethics or integrity, or undertake legal risks while pursuing business goals * Demonstrates leadership among peers by consistent application & modeling of appropriate compliance, behavior & conduct * Reimbursement Related Experience * Experience with physician administered injectables preferred * Excellent reimbursement expertise and payer knowledge preferred * Knowledge and experience of legal and regulatory requirements related to the Biotech / Pharmaceutical industries * Field Development, Planning, & Support * Spends majority of time visiting customer accounts in the field * Works with manager, peers and partners in Marketing, Sales and various Managed Markets and Trade groups to review/understand relevant franchise and managed care business plans, tactics, goals and objectives * Spends considerable time and effort working with field partners in Sales reviewing their territory business plans and progress, helping to identify reimbursement-specific opportunities or issues, as well as educating partners on the payer landscape Job Knowledge: * Maintain a high level of Managed Care and related Managed Markets benefit structures, reimbursement mechanisms, legal and regulatory influences, and health management programs. * Maintain consistent ability to access and influence key business decision makers. * Maintain a high level of industry awareness. * Maintain an outstanding level of Multiple Therapeutic Area knowledge, utilization management techniques, treatment and reimbursement guidelines. * Maintain an outstanding level of performance metric analytics. * Maintain a comprehensive and detailed Territory Plan. * Maintain an outstanding ability to prepare and present provider level communications. Planning and Analysis: * Maintain an outstanding level of territory planning, organization, and administrative skills. * Manage territory and all assigned accounts within set budget. * Develop and justify budgeting requests for specific customer programs. Communications: * Demonstrate strong oral, written, and group communication skills. * Maintain frequent contact with Field Leadership and local field staff. * In a timely and accurate manner, submit all budgetary information, expenses reports, and required administrative reports to Field Leadership. * Maintain effective communication with customers and affiliates. * Seek out and maintain an effective level of communication with account stakeholders and decision makers. Minimum Requirements: Education & Sales Experience * Bachelor's Degree (MBA or other related graduate-level degree is preferred) * Minimum of 5 years of total business experience in the healthcare or pharmaceutical/biotech industry * Minimum of 2 or more years' sales, managed care or reimbursement experience is required Preferred Experience / Background: * Two to four years Biotech or Pharmaceutical Sales experience. * Two to four years of Managed Markets experience. * Infectious Disease, Respiratory, Inflammation, Autoimmune, Oncology, Cardiovascular and Neuroscience experience. * Experience with business planning and market analysis. * Experience in implementing value added programs and advisory programs. * Experience with oncology highly desirable ~BSP *LI-MEDI Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Additional Notes Territory includes San Antonio, TX region Req ID 9563 Position Category Sales Support

Posted On - 5/29/2015 7:26:16 AM

Facilities and Engineering Contracts Specialist

Frederick MD

Position: Demonstrated ability to adhere closely to all company Standard operating Procedures at all times, adhere to schedules Demonstrated ability to work independently, meets critical deadlines, and achieves results. Demonstrated understanding of the annual budget process and forecasting associated with tracking vendors expenses Ability to understand and manage budgets including vendor contracts and capital purchase requests Comfortable presenting material to internal staff members and broader audiences, as appropriate. Provide "inspection ready" records Education: Associates degree with 3 years relevant experience, or High School diploma or GED and 5 years of job related experience. *LI-MEDI Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Additional Notes Ability to interface with various levels and organizations throughout FMC Excellent written and verbal communication skills Proficient in computer skills and MS Office applications Ability to support timely execution of Quality records, Quality document generation and corrections, and minor project management Thorough understanding of SAP and Business System Alignment (Trackwise, Aegis, iBuy, iSave, ePay) Ability to administer F&E SharePoint Site Must be able to work in a fast-paced environment and be well organized. Req ID 9560 Position Category Engineering & Facilities

Posted On - 5/29/2015 7:26:16 AM

Associate Director, Quality Systems

Philadelphia North PA

•Minimum of 10 years of experience in the Biopharmaceutical/pharmaceutical industry, with at least: •7 years of experience working in the manufacturing, QC or QA/Validation of Biologics (e.g., recombinant proteins, monoclonal antibodies, vaccines). •5 years minimum experience of established leadership in biopharmaceutical/pharmaceutical industry •Broad understanding and current knowledge with global cGMP regulations and guidelines •Knowledge and broad scope in fundamental Quality systems, such as auditing, change management, failure investigations, documentation management, Quality Risk Management, and qualification/validation. •Excellent interpersonal skills, including ability to forge strong relationships and influence others across business disciplines and levels of the organization •Good verbal and written communications skills •Working knowledge of Quality Information Systems (e.g., Trackwise) is preferred Education: Bachelor's Degree in sciences (e.g., Biology, Microbiology, Chemistry or Engineering) required ~BSP *LI-MEDI Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Additional Notes Req ID 9561 Position Category Operations - Quality

Posted On - 5/28/2015 7:24:40 AM

Global Procurement Manager/Senior Manager

Gaithersburg MD

•Minimum of 5 -- 7 years strategic sourcing (or sourcing consulting) for Pharmaceutical, Consumer Package Goods, Heath and Beauty Aides or other like industries •Demonstrated success sourcing a broad range of goods and services such as but not limited to the following: •Professional Services •IT and/or Business Consulting •Financial Consulting / Audit •Clinical Research •Direct Materials •Small and/or Large Capital Expenditures •Business process outsourcing Education : Bachelor's degree in business or a related field such as Supply Chain, Business, Economics, Finance, or other. MBA or JD a plus *LI-MEDI Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Additional Notes •Exceptional track record of building relationships with stakeholders •Demonstrated proficiency influencing people, problem solving and decision making •Excellent communication and project management skills •Superior project management skills •Advanced Excel and PowerPoint skills •SAP or Ariba a plus Job Complexity : This is a highly complex position. The candidate will be required to "win" the trust of stakeholders, establish strong relationships and drive stakeholder value all while impacting the "bottom line". Supervision : The candidate will be a highly experienced individual contributor. He/she will be empowered to independently drive results. Strategy will be determined through collaboration of Sourcing management and stakeholder input. Req ID 9148 Position Category Operations - Supply Chain & Strategic Sourcing

Posted On - 5/28/2015 7:24:40 AM

R&D Associate I / II, Molecular Virology

Gaithersburg MD

Education/Experience: R&D Associate I Level: BS with 0 -2 years experience R&D Associate II Level: BS with 2 - 5 years experience MS with 0 - 2 years experience * Degree in virology, molecular biology, immunology, or other related field. * Relevant experience in industry (preferred) or academia Position: He/she will have general knowledge of the fields of virology, molecular biology and immunology. Required Experience: * Strong hands-on experience with cell culture and viral propagation * Experience with molecular biology techniques such as molecular cloning, site-direct mutagenesis, RT-PCR and qPCR * Strong assay development skills * Experience performing standard laboratory procedures for the study of protein expression such as Western blot, ELISA and immune-staining techniques * Willingness to work with BSL-2 and BSL-2* infectious agents (vaccination will be required) * Ability to prepare precise technical reports, summaries, protocols, quantitative analyses, and maintain appropriate documentation * Ability to conceive experimental designs, interpret data, propose to improvements to and troubleshoot experimental protocols * Strong verbal and written communication skills * Highly organized with the ability to develop focused work packages, prioritize based on defined goals, and work both independently and as part of a team Preferred but not required: * Experience with DNA viruses * Experience in working with animal models for oncology or chronic viral disease * Experience developing therapeutic vaccines for chronic viral infections * Experience in evaluating immunological responses to viral infection by various means such as multi-color flow cytometry, EliSpot, MSD and Luminex LI-MEDI Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Req ID 9553 Position Category Research - Infectious Disease

Posted On - 5/28/2015 7:24:40 AM

QA Specialist IV/QA Manager

Gaithersburg MD

Position: Knowledge: Complete understanding and wide application of technical principles, theories and concepts in the areas of clinical manufacture of biologics. To include process development methodology, analytical methods, technology transfer, and CMC Processes. General knowledge of other related disciplines. Problem Solving: Provides technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable and consistent with organizational objectives. Discretion / Latitude: Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy, in meeting objectives. Impact: Contributes to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources. Liaison: Inter-organizational and outside customer contact. Typical Education: B.S. in Biology, Chemistry, Engineering or related fields required. MBA or Masters degree a plus. Typical Experience: 7+ years experience in auditing, project management or quality assurance. Industry experience required. *LI-MEDI Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Additional Notes Technical Knowledge: GMPs, database knowledge, non-conformance investigations, root cause analysis and development of corrective actions, trend analysis. Language Skills: Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations. Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public. Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Computer Skills: Outlook, Deviation, CR Tracking Software, EDMS, Explorer, Excel, Word, MS Office Req ID 9534 Position Category Operations - Quality

Posted On - 5/28/2015 7:24:40 AM

Material Handler II

Frederick MD

Position: * 2-8 years experience in warehouse, inventory control, or life sciences roles preferred, depending on job level. Education: * High school diploma required. ~BSP *LI-MEDI Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Additional Notes * Familiarly with inventory control systems and computer office programs. Req ID 9547 Position Category Manufacturing and Production

Posted On - 5/28/2015 7:24:40 AM

Associate Scientist I / Associate Scientist II, Bioprocess Engineering

Gaithersburg MD

Education: Associate Scientist I Bachelors Degree and 5 - 8 years of experience Masters Degree and 2-5 years of experience Associate Scientist II Bachelors Degree and 8-10 years of experience Masters Degree and 5-8 years of experience Position: * Ability to plan and conduct experiments, review and provide feedback for manufacturing documents and data. Prepare and analyze data to present to cross-functional teams. * Excellent understanding of purification operations such as chromatography, ultrafiltration, diafiltration, and viral filtration. * Working knowledge of Microsoft Excel, Word, and PowerPoint * Ability to work well in teams across multiple functional areas * Knowledge of cGMPs * Excellent written and oral communication skills * Understanding of purification process scale-up and large scale processing equipment * Demonstrated leadership capabilities * Past experience in process tech transfer to GMP operations is ideal LI-MEDI Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Req ID 9505 Position Category Development - Bioprocess Engineering

Posted On - 5/26/2015 7:33:00 AM

Communications Specialist

Frederick MD

Position: * 1-3 years of experience in in a corporate communications function or public relations agency Education: Bachelor's degree in Communications, Journalism, Public Relations, English or related Communications field ~BSP *LI-MEDI Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Additional Notes Excellent writing, editing and proofreading skills * Knowledge of MS Office applications * First-rate coordination, collaboration, organization and multi-tasking skills * Ability to establish and meet deadlines, work under pressure and handle multiple priorities Excellent writing, editi Req ID 9551 Position Category Human Resources

Posted On - 5/26/2015 7:33:00 AM

Director, R&D

Gaithersburg MD

Position: * Extensive expertise and experience in discovery, optimization, and development of antibody-drug conjugates (ADCs) for cancer, including target selection, ADC construction, and preclinical and clinical testing. * Ability to lead cross-function drug discovery projects, with track record of successfully advancing one or more such projects. * Proven skills in managing research scientists, including Associate Scientists, Ph.D.s, and project leaders. * Ability to work effectively in a matrix environment, working with colleagues across several departments to effective advance projects and technology development. * Extensive experience across all phases of drug discovery, from target selection to candidate drug development to early clinical testing, including translational biology. * Broad and deep knowledge of cancer biology, including cancer targets, signal transduction, in vitro and in vivo models, and understanding of different cancer types including solid tumors and hematologic malignancies. * Track record of effectively managing successful external collaboration with both industry and academia. * Strong publication record and demonstrated ability to communicate effectively to diverse audiences, including presentations at scientific conferences. * Demonstrated abilities to define and implement research strategy and set priorities. * Record of innovation and ability to identify and develop new technologies. * Ability to work in a fast-paced, interactive environment and adapt quickly to change. Education: * Ph.D. in appropriate discipline (e.g., cell biology, molecular biology, biochemistry) and 6 years of experience Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Req ID 9514 Position Category Research - Oncology

Posted On - 5/26/2015 7:33:00 AM

Facilities Maintenance Tech. III

Gaithersburg MD

Position: Ability to read and interpret documents such as safety regulations, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively with customers or employees of organization. Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to solve practical problems and deal with a variety of variables in situations where only limited information exists. Ability to work on multilple tasks at any given time. Outlook, Internet Explorer, Capability to Utilize Various Programs Developed for Day to Day Operations & Specialty Maintenance PM Software to have Knowledge of Purified water systems,Pre treatment , RO Skids ,Carbon towers, CDI/EDI's and WFI Still's. **Minimum of 3yrs cGMP or cGxP experience.** Must be able to work in a gown room enviroment for many hours per day. Education: Certificate of Completion at a 2 year technical trade school or, High School diploma with experience in maintenance trades working in Pharma, Biotech or other highly regulated industry, Journeyman May include some or all of the following - Appropriate plumbing, HVAC, electrical, and mechanical Licenses (Maryland - EPA Refrigerant Recovery Type I, II, III or Universal Certification or Stationary Engineer Level II or III as required) and/or equivalent work experience to insure working knowledge ~BSP *LI-MEDI Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Additional Notes Responsible for mechanical repairs and in house repairs throughout facility. Performs work within multiple maintenance trades ie. carpentry/painting, electrical, plumbing and mechanical repair. Performs routine equipment/system repair, lab/office repair/renovation, system/equipment installation and system/equipment preventive maintenance/sanitization. Makes periodic or special inspections of facility equipment/systems to determine repair work necessary and to confirm system/equipment operation is within specified parameters. Will be required to assist in Project Management throughout the facilities and oversee the work of contractors. Independent thinking and decision making is required. Additional Job Functions: Use basic & precision hand tools Utilize precision measuring instruments Must be able to read, write and utilize complicated drawings, mathematics, handbook formulas, and a variety of precision measuring instruments. Read mechanical schematics/piping diagrams Experience in the maintenance trades, trade knowledge in a specialized field or process Must be able to work (troubleshoot/perform repairs) in a clean room environment. Overtime as required On-call after hours support Tig Weld and Fabricate Stainless Steel MIllwright abilities, Equipment set up and rigging Req ID 9222 Position Category Engineering & Facilities

Posted On - 5/26/2015 7:33:00 AM

Senior Data Management Project Lead

Gaithersburg MD

Position: Sr. DMPL- Minimum*of 10 years of Data Management experience in the Biotech/Pharma/CRO industry DMPL- Minimum*of 8 years of Data Management experience in the Biotech/Pharma/CRO industry Education: Minimum of a BS in life sciences degree and/or equivalent experience Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Additional Notes *Demonstrated knowledge of clinical and pharmaceutical drug development process * Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and acrivities * Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) * State of the art understanding of database structures, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting * Experience of clinical databases, different clinical data management systems and electronic data capture (EDC) * Demonstrated understanding of clinical data system design /development /validation and system interoperability. * Demonstrated leadership (including in an outsourced environment) * Demonstrated project management skills * Superior communication and interpersonal skills * Excellent organizational and analytical skills * Ability to work independently and act as role model/mentor for junior staff * Demonstrated ability to work effectively with external partners * Ability to negotiate and influence others across functional areas * Proven problem and conflict solving skills * Ability to work in a global team environment * Ability to interact effectively with all levels of management * High attention to detail and accuracy Req ID 9542 Position Category Clinical Operations

Posted On - 5/26/2015 7:33:00 AM

Senior Toxicologist / Principal Toxicologist, Biologic Non-Clinical Safety

Gaithersburg MD

Principal Toxicologist Education: Ph.D. in Toxicology or Biomedical Sciences (e.g., immunology or pharmacology) Position: 7-10 years post-Ph.D. experience, including 5 years in biopharmaceutical research. Senior Toxicologist Education: Ph.D. in Toxicology or Biomedical Sciences (e.g., immunology or pharmacology) Position: 5-7 years post-Ph.D. experience, including 5 years in biopharmaceutical research. Other Skills: Hands on and project management related experience in preclinical safety of biologics and vaccines. Ability to interact successfully in a cross-functional team setting. Understanding of CRO functions and how to work with CROs. Experience working with common toxicological species, including primates. Understanding of toxicological mechanisms as the basis for developing safe medicines. Understanding of the regulatory requirements for the toxicology testing of biologics. Understanding of the drug development process. Basic understanding of immunology. Basic understanding of pharmacokinetics and PK/PD relationships, in particular in relation to biologics. Basic understanding of CMC for biologics. Knowledge of the mechanistic basis of disease processes in humans. Knowledge of medical terminology. Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Additional Notes Req ID 9539 Position Category Research - Translational Science

Posted On - 5/26/2015 7:33:00 AM

Senior Project Manager, Global Biological Operations

Gaithersburg MD

Position: Required Skills/Experience * 3 years minimum experience in the pharmaceutical, biopharm or GMP industry; must be familiar with pharma or biopharm GMP * Demonstrated track record of success in delivering strategic, complex, cross-functional and multi-site projects on-time, on-budget and to committed deliverables to generate significant business value * Takes appropriate initiative and accountability * Strong interpersonal and communications skills * Strong team management skills Preferred Skills/Experience: * 5 years minimum experience in the pharmaceutical or biopharma industry in a manufacturing, technical or related role * Technology transfer, manufacturing scale-up or new product launch experience * Strong knowledge of pharmaceutical/biopharm GMP * Experience in a biopharm operations a plus but not required * Experience working globally, leading virtual teams in a matrixed environment * Experience presenting to or communicating with senior management * Project Management certification is a plus but not required Education: * BS in Engineering, Science or related field + 8-15 years of Project Management experience * MS, MBA or other advanced degree preferred ~BSP *LI-MEDI Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Additional Notes Required Skills/Experience * 3 years minimum experience in the pharmaceutical, biopharm or GMP industry; must be familiar with pharma or biopharm GMP * Demonstrated track record of success in delivering strategic, complex, cross-functional and multi-site projects on-time, on-budget and to committed deliverables to generate significant business value * Takes appropriate initiative and accountability * Strong interpersonal and communications skills * Strong team management skills Preferred Skills/Experience: * 5 years minimum experience in the pharmaceutical or biopharma industry in a manufacturing, technical or related role * Technology transfer, manufacturing scale-up or new product launch experience * Strong knowledge of pharmaceutical/biopharm GMP * Experience in a biopharm operations a plus but not required * Experience working globally, leading virtual teams in a matrixed environment * Experience presenting to or communicating with senior management * Project Management certification is a plus but not required Req ID 9529 Position Category Operations

Posted On - 5/26/2015 7:33:00 AM

Senior Principal Statistician

Gaithersburg MD

Position: For the Senior Principal Statistician level we require the following: Minimum 4 years of industry experience in clinical study environment as a lead study statistician. Experience as a lead statistician at compound level (preferred). For the Science Associate Director level we require the following: Minimum 6 years of industry experience in clinical study environment including lead statistician role at compound level. Education: MS or PhD in statistics or other related field with high statistical content. Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Additional Notes For the Senior Principal Statistician level we require the following skills: * Comprehensive knowledge of and experience with statistical methods and applications in study design and analysis * Ability to effectively oversee work of outsourcing partner * Ability to effectively collaborate, communicate, and influence throughout multiple levels of the organization * Experience in development of clinical development plans, protocols, statistical analysis plans, and clinical study reports * Experience as an independent lead statistician with responsibility for multiple studies or projects * Experience in regulatory interactions and submissions For the Science Associate Director level we also require the following additional skills: * Ability to innovate creatively in a clinical study design setting * Ability to communicate with clarity and influence * Knowledge of ICH/EMEA/FDA guidelines * Demonstrated ability to serve effectively as a delivery team leader * Ability to manage and mentor project statisticians Req ID 9536 Position Category Clinical Development

Posted On - 5/26/2015 7:33:00 AM

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