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Company Jobs - MedImmune


 

Clinical Operations Program Lead

Gaithersburg MD

Required Experience: * Minimum of twelve years of experience in the pharmaceutical industry. * Minimum of six of those years must have been working in an environment of clinical study delivery/clinical project management. * Extensive and proven experience in driving operational delivery to timelines, cost and quality * Proven experience of leading delivery through collaboration with internal organization and external providers * Significant experience and expertise in Clinical Trial methodology with a proven ability to deliver differentiated options based on a sound knowledge of operational delivery * Proven ability in proactive problem solving and risk management that is solution focused * Proven Global Project Management experience with expertise in program level resource and budget management * Preferred program level experience across the product life cycle and across multiple therapeutic areas, with experience in global drug development * Experience and strength in working and leading in matrix teams. Education: * Bachelors of Science or Bachelor of Arts degree in related discipline, preferably in medical or biological science, or equivalent work experience in directly related fields of endeavors. Advanced degree is preferred. * Certification or Degree in Project Management is a plus. Special Skills/Abilities: * Requires minimal guidance and oversight from the Therapeutic Area Director (TAD). * Strategic Skills including a high level of creativity, innovation, and problem solving with an ability to manage effectively through ambiguity. * Strong collaborative communications ability to engage with a diverse client base inclusive of high level conflict management capabilities * Manages the Clinical Operations remit within the PDT and/or GPT structure * Ability to motivate team members and build cross functional teams in support of the PDT/GPT vision * Can provide strong leadership and facilitation skills to link strategic direction to a clear operation plan The appropriate candidate must: * Act Decisively * Work collaboratively * Exhibit passion for customers * Drive performance * Think Strategically * Develop people and organization * Posses positive change management skills, at all levels including individually, team and the business, seeing change as an opportunity to improve performance and add value to the business * Willingness to travel both domestic and international

Posted On - 7/11/2014 7:16:19 AM

Senior Manager, Operational Excellence

Philadelphia (Non Sales) PA

Position: Works with other members of the Site Leadership Team (SLT) to define the OE future state. Responsible for developing and driving plans to for an OE culture aligned with the Shingo Prize. Establishes site OE goals to include financial and cultural objectives. Builds employee capabilities in OE and engages all employees in the site OE initiatives. Tracks and reports on the health of the site's OE Program and Culture. Including: -Employee engagement -% yellow belt and green belts -% lean manufacturing trained -Cycle time of certification -Cost of Goods savings due to OE initiatives Provides technical leadership, mentoring, and project support as required to support Lean/6 Sigma initiatives. Manages the Site Metrics and Site Metric cascade. Implements recognition initiatives to reinforce the OE culture. Develops direct reports as assigned. Works with multiple teams and sites to develop and implement improvement opportunities. Facilitates sharing of best practices with other sites and internal/external benchmarking. Member of the Site Senior Leadership Team. Education: BS/BA in engineering, physical or life sciences or business *LI-MEDI

Posted On - 7/11/2014 7:16:19 AM

Senior Scientist/Associate Director

Gaithersburg MD

Position: One key area of responsibility will be managing enterprise wide LAP activities for AZ-Supply Biologic's LAP project, which include the following functions: * Accountable for coordination of the business team -- Collaboration lead for the business team * Ensure the project is resourced correctly from a business standpoint o Accountable for ensuring that Information owners are identified and their information security requirements are defined and met. o Define/Agree the scope of the user population o Ensure that team members are aware of their responsibilities and are appropriately trained o Accountable for ensuring that Information owners are identified and their information security requirements are defined and met. * Ensure systems are used correctly in accordance with defined policies and procedures * Accountably for the review, approval, maintenance and/or availability of relevant business/system documentation including: o User Requirements and Use Cases o Current Capability Assessment o Business Process Design - Current and To-Be o Return On Investment o Regulatory Impact Analysis o System Impact Analysis o Standard Operating Procedures (SOPs) o VSCR Accountable for ensuring that formal user acceptance of the system is conducted against requirements and accepts accountability for changes to the system during its lifecycle. * Maintain awareness of the business and regulatory risks associated with the system and owning those risks. Ensure that risks associated with the system are assessed and mitigated and accepting the risks that are not mitigated * Ensure a Business Continuity Plan is in place, including Disaster Recovery, where necessary * Requires very strong collaboration skills to interact with diverse stakeholders. Another key area of responsibility will be to provide support to enterprise wide analytical activities within the Operations group. This will include: * Providing direct technical support as needed at the site level in a consulting or SME role * Helping to develop and maintain analytical technical policy (standards) & governance across all Operations sites. * Helping to manage analytical services outsourced to contract testing laboratories from contract manufacturing facilities * Providing SME input for biosafety assays Knowledge o Has extensive expertise in implementing and using LIMS systems. o Has a working knowledge of related disciplines (e.g., IT hardware and software systems) required for the implementation of LIMS. o Displays a good understanding of analytical procedures, stability testing, environmental monitoring, etc., to enable the user friendly configuration of the LIMS system and to be a technical expert on analytical methods Problem Solving o Develops solutions to complex problems requiring ingenuity and creativity. o Demonstrates leadership and ability to work with individuals from multiple AZ-Supply Biologic's sites with diverse needs to develop solutions that meet the needs of the enterprise o Applies knowledge of LIMS theories and principles on a broad base where analysis of situations or data requires an in-depth evaluation of various factors. o Displays knowledge about how the organization works. Can solve problems through formal channels and informal networks. Freedom to Act o Work is performed with limited direction. o Has latitude in determining objectives of assignment. o Work is monitored for judgment and achievement Impact o Decisions or recommendations consistently result in achieving one or more key project objectives. o Internal recognition as an LAP expert by the AZ-Supply Biologics community. o Has demonstrated leadership through project team participation, internal consulting and ability to achieve consensus amongst groups with diverse needs o Has a clear understanding of departmental direction and is expected to voice opinions and ideas Interpersonal Communications o Frequent inter and intradepartmental collaborations. o Establishes contacts with groups at all AZ-Supply Biologics sites and has contacts with customers and suppliers. o Demonstrates ability to resolve conflicts between team members. o Demonstrates the ability to effectively explain complex scientific concepts to a broader, diverse audience. Education and Experience Guidelines: BS with 15-17 years of experience in implementing and using LIMS in an industrial setting, or MS with13-15 years of experience, or PhD with 7-10 years of experience in a biotech/pharmaceutical environment. *LI-MEDI

Posted On - 7/11/2014 7:16:19 AM

Associate Scientist II/Scientist I,

Gaithersburg MD

Required Education: * BS degree in the life sceinces with a minimum of 8 years of relevant experience * MS degree in the life sciences with a minimum of 5 years of relevant experience * PhD with 0 - 3 years of experience Required Knowledge and Skills: * Strong scientific understanding of metabolic and cardiovascular diseases. * Significant experience outside of an academic and institutional setting in a biotech or pharmaceutical company is preferred. * Experience with automation and expertise in performing high throughput assays: 96- and 394-well cell-based assays and biochemical assays. * Expertise in performing multiple functional assays relevant to metabolic diseases (for example, glucose-stimulated insulin secretion, hepatic glucose output, lipolysis, lipogenesis and / or glucose uptake assays). * Experience handling biological samples (tissues, plasma, serum) for analytical purposes. * Ability to handle biopharmaceutical compounds for in vitro and ex vivo pharmacology studies. * Extensive hands-on research experience and technical skills. * Excellent organizational skills, record keeping and data presentation, and capable of independently designing and executing experiments. * Proven ability to generate high quality data in a timely manner to facilitate data-driven decision making, as well as reports for internal meetings, publication in peer reviewed journals or IND filings. * Excellent interpersonal and oral as well as written communications skills. * Excellent ability to collaborate with scientists internally and externally to achieve the goals of the department. * Broad hands-on technical skill set should include basic cell biology, molecular biological and biochemical techniques, including tissue culture, cell separation technologies, functional cell-based in vitro assays with multiple cell types, ELISA, multiplex assays, qRT-PCR, western blotting, IHC among others and should be familiar with latest lab technologies and opportunities. * Hands on in vivo experience with animal models of obesity and diabetes is highly desirable. ~BSP

Posted On - 7/10/2014 7:13:26 AM

Manager, Regulatory Affairs

Gaithersburg MD

Required Education and Experience: * BS or MS in a scientific discipline with at least 2 years in Regulatory Affairs or 6 years overall relevant experience, preferably in biotechnology or pharmaceutical industries. * Self-motivated/pro-active and with ability to multi-task. * Excellent planning and organizational skills. * Attention to detail and accuracy. * Strong interpersonal communication skills. * Excellent oral and written communication skills. * Ability to make accurate and timely decisions. * Comfortable interacting with senior staff. * High standard of professional ethics, integrity, and trust. * Ability to work independently. * Knowledgeable on the drug development process. * Ability to interpret, understand and effectively communicate all relevant FDA, ICH, RoW regulatory requirements both internally and to external clients. * Effective in a highly matrixed organization and able to manage cross-functional teams and external business partners. * Proficient in Microsoft Office, electronic data management and submission management systems, global regulatory and biopharmaceutical databases/search engines.

Posted On - 7/10/2014 7:13:26 AM

Post Doctoral Fellow - Innate Immunology

Gaithersburg MD

Experience: 1-3 years post-doctoral research. Demonstrated ability to conduct a high level research project. Must be highly motivated and capable of working independently as well as collaboratively within a team. Education: Ph.D. in Immunology, Biochemistry or a closely related field. Candidate should have a strong interest in Innate immunology and/or Respiratory Biology *LI-MEDI ~BSP

Posted On - 7/10/2014 7:13:26 AM

Senior Finance Analyst

Gaithersburg MD

Minimum Requirements & Experience: * A focused financial professional with strong analytical and customer service delivery skills * 5 or more years experience with financial modelling, forecasting, and business decision support * Proficient in the use of accounting systems & working knowledge and understanding of various financial systems and processes * Strong Excel skills * Strong organizational and communication (written, verbal) skills * Thorough understanding of functional cost drivers and able to deliver variance explanations * Able to understand the value of business drivers within a business area, to work collaboratively developing accurate forecasts, and to support strategic business decisions * Bachelors degree in Finance, Accounting, or similar Desirable: * MBA, with specialization in Finance * Financial Planning & Analysis experience * Experience working in a global organization, preferably within the pharmaceuticals industry, and knowledge of the drug development life cycle and commercial aspects of the industry * Experience of working within a multi-disciplinary team and liaising with senior managers * Demonstrated experience working in a customer facing role with finance business partnering * Good cultural awareness, exposure to global working, collaboration and teaming skills BSP

Posted On - 7/10/2014 7:13:26 AM

Senior Statistician, Non Clinical Biostats

Gaithersburg MD

Required Education and Experience: * PhD in statistics or other related field with high statistical content with at least 4 years of relevant industry experience. Required Skills: * Sound understanding and application of statistical methods and applications * General knowledge of drug R&D regulatory process approval * Proficient with SAS and other analysis software * Effective oral and written communication skills and interpersonal skills

Posted On - 7/10/2014 7:13:26 AM

Associate Data Management Project Lead

Gaithersburg MD

Position: *Minimum of 8 years of Data Management experience in the Biotech/Pharma/CRO industry Education: *Education: Minimum of a BS in life sciences degree and/or equivalent experience ~BSP *LI-MEDI

Posted On - 7/9/2014 7:21:42 AM

Associate Director, Regulatory Affairs

Gaithersburg MD

Position: A minimum of 8-10 years of increasing documented success in biopharmaceutical field, with a minimum of 5 years in regulatory affairs biotechnology CMC. BLA/CTD submission experience a plus. Consideration will also be given to individuals who have worked for a regulatory agency in a biologics CMC review role with a minimum of 5 years of review experience. Education: BS/MS in a scientific discipline. ~BSP *LI-MEDI

Posted On - 7/8/2014 7:24:31 AM

Counsel, Intellectual Property

Gaithersburg MD

Position: At least 4 years life science patent prosecution experience with global portfolios, combined in-house and law firm experience preferred Education: Licensed US Attorney, USPTO Registration Number Ph.D. or equivalent, and/or several years of laboratory experience in relevant scientific area ~BSP *LI-MEDI

Posted On - 7/8/2014 7:24:31 AM

Manager, Field Reimbursement

Jacksonville FL

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 * Bachelors 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. *LI-MEDI

Posted On - 7/8/2014 7:24:31 AM

Scientist I / II

Gaithersburg MD

Education: * Ph.D. in Chemical Engineering / Biochemistry/ Bioengineering/ Cell Biology with demonstrated (0-2 years for Scientist I, 3+ years for Scientist II, * or Masters degree with 10+ years of commensurate experience) publication record in the area. 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. * A strong background in metabolic engineering and an innovative approach to novel fed-batch process development is essential for the job. * Interest in automation and process integration is an important need for this position. * Excellent laboratory skills are essential for success in this job. * The candidate should maintain accurate records of data, equipment calibration, equipment logs and actively participate in laboratory organization. * The individual should 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. * Experience working in a collaborative environment is an important requirement of this position due to the need for 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. * 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. * Must have the ability to independently coordinate and prioritize multiple projects in a fast-paced environment, as well as the ability to work with individuals from multiple technical areas and with varying levels of scientific and technical expertise. * Track record of delivering innovative solutions to enable non-mAbs production using non-fed-batch approaches are a plus. * Candidate 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. * Leadership in a laboratory environment and strong experimental design, statistical and data analysis skills are expected. Knowledge of other areas on biopharmaceutical process development -- purification, formulation, analytical methods, - are desirable. * Must also have strong written and verbal communication skills. * Publications in peer-reviewed journals highly desirable. * Strong work ethic and an entrepreneurial spirit are required. * Strong laboratory skills with experience in mammalian cell culture and aseptic techniques is a requirement. * Experience with high-throughput bioreactor, perfusion culture, and non-mammalian expression platforms are a plus. * Demonstrated understanding and application of engineering and bioprocessing principles to areas of cell culture is required.

Posted On - 7/8/2014 7:24:31 AM

Senior Director,Product Development TL

Gaithersburg MD

Major Requirements: * 8-10 years of oncology pharma experience in drug development, including early phase progression from discovery thru mid-stage development. * Oncology-focused, immunology-based career focus. Expertise in translational sciences, at the MD or PhD level, is desirable. * Extensive academic and pharma collaborative network. History of personal interaction with thought leaders in area of biologic and immune therapy of cancer * Track record of program leadership and achievement of goals and deliverables. * Program leadership in drug development in oncology in a pharma/biotech setting is required * Biologics experience is highly desirable. * Strong organizational and management skills * Strong communication skills * Ability and demonstrated record of decision making, influencing, leadership, and effecting change. * High personal and scientific integrity * Track record of effective collaboration, effectiveness in team settings, and team leadership Education: * PhD in immunology, oncology-focuses area; appropriate peer-reviewed publications, recognition by thought leaders in area of immunology and oncology. * Expertise in translational medicine, via a PhD or MD level training, is highly desirable

Posted On - 7/8/2014 7:24:31 AM

Informatics Scientist

Gaithersburg MD

Qualifications and Experience * Degree level science based education essential. * Postgraduate education in science, or computer science a plus. * Demonstrable ability to create high quality software & thorough knowledge of the Java platform a plus. * Understanding of/or interest in biology and the business of drug discovery and development. Specific Skills: Technical * Ability to create high quality software with rich client front ends, Java application servers and a relational database backend. * Experience is designing software that is reusable and maintainable. * Experience in designing and querying databases, data modelling and integration. * Experience in test driven development and the use of version control, build automation, continuous integration and issue tracking tools a plus. * Ability to lead new development projects and coordinate with other team members and key stakeholders. Scientific * Hands on experience with R&D and the handling & analysis of scientific datasets a plus. * Hands on experience with existing scientific tools and databases, data formats/sources. * Track record of innovative research an advantage. Personal * Ability to communicate effectively with technical and scientific colleagues alike, in formal presentations and small group meetings. * Ability to work effectively alone or as part of a team. Able to work effectively with colleagues in Medimmune and collaborate externally. * Driven to provide high quality solutions, proactive in identifying potential problems before they occur and in identifying and managing risk. * Thoroughness and tenacity in solving problems. * Excellent analytic skills -- able to see the underlying problem and synthesize transformative solutions. *LI-MEDI ~BSP

Posted On - 7/7/2014 7:28:01 AM

Regulatory Affairs Associate II

Gaithersburg MD

Position: The candidate should have between 1-3 years experience in the pharmaceutical/biotech industry. Experience in electronic submissions and/or vaccine products is highly preferable. This is an entry level regulatory affairs position. The successful candidate must possess strong computer, communication, and organizational skills. Education: BS/MS or equivalent ~BSP *LI-MEDI

Posted On - 7/7/2014 7:28:01 AM

Architect Short Term Rotation Role

Gaithersburg MD

Candidate Knowledge, Skills and Experience The Associate Architect is expected to have or to develop an understanding of all 3 areas below and expertise in either the Life Science or Pharmaceutical area. * Life Science Understanding of information challenges in preclinical and clinical areas. Some knowledge of a specific therapy area and of AZ's drug pipeline. Knowledge of the scientific information supporting drug project decision making. * Pharmaceutical & Commercial Understanding of the commercial processes supporting launched products. Knowledge of the information needed to provide clinical evidence to Payers. Knowledge of the external factors impacting on the Pharmaceutical industry * Supply Chain & Enabling Knowledge of pharmaceutical supply chain process and information Knowledge of key enabling business processes; legal, HR, Finance and Communications In addition, Candidates will be expected to demonstrate: * Mobile application development * Major SAAS products * Cloud and SAAS integration * Application and data integration using SOA * Web application development * System usability and design * Identity and Access management * Cloud security * Software engineering * Innovation Relevant expertise and experience of at least three of: * Strong Collaborator * Capability of business Innovation * Previously delivered cloud systems or mobile applications * Influencing skills * Good communication skills

Posted On - 7/3/2014 7:20:41 AM

BMS Engineer

Frederick MD

Position: This person must to able to perform Siemens Apogee programming, understand PPCL, be able work with Microsoft Office, able to install new equipment, point and logic, and have and understanding of BacNet. Education: Two years or greater college education and 5 years of experience with Siemens Apogee. *LI-MEDI

Posted On - 7/3/2014 7:20:41 AM

QC Analyst

Frederick MD

Position: Preferred 0-5 years experience Education: Bachelors: Scientific / Biotech / Pharmaceutical field of study Position: Ability to learn and develop technical skills. Ability to work under GMP requirements. Requires attention to detail and organization/time managment capabilities.

Posted On - 7/3/2014 7:20:41 AM

Senior Project Manager - IT

Gaithersburg MD

Position: *10+ years professional work experience *7+ years in project management, preferably in IT supporting Pharmaceutical or Biotech R&D, with a track record of managing multiple medium to high risk projects simultaneously, while meeting delivery, quality, and compliance standards *5+ years managing vendor relationships and managing partner resources *3+ years experience in an FDA regulated industry such as pharmaceutical or biotech is highly desirable Education: *Bachelor's degree required; Master's degree desirable *PMP certification highly desirable ~BSP *LI-MEDI

Posted On - 7/3/2014 7:20:41 AM

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