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Company Jobs - MedImmune


 

Director, Partnerships & Collaborations

Gaithersburg MD

Position: Help develop and implement a government, university and non-profit partnering strategy for MedImmune's Biotech Hubs and Collaborations team Engage and lead internal and external people and resources to demonstrate MedImmune's advantages to external partners such as academic institutions, non-profit organizations and government agencies Identify and develop new strategic collaboration opportunities to help MedImmune achieve its corporate and financial objectives Collaborate with internal stakeholders to ensure MedImmune's industry collaborations are coordinated across functions and aligned to overarching partnering strategy, while meeting the scientific goals of MedImmune Lead outreach and negotiations of these collaborations with both internal stakeholders and stakeholders to close the alliance deals and manage the relationship Measure and communicate joint value realized by MedImmune's industry partnerships to help ensure strength of relationship and ongoing success of the overall collaborations Evaluate alliance and partnership trends and provide analysis and recommendations to management Facilitate delivery of key projects to ensure they are executed in a timely manner Seek new ways to secure alternate sources of funding for R&D activities, though external collaborations and/or partnerships, primarily via government and non-profit collaborations Build strong relationships with academic and government partners in key biotech hubs Design and implement events such as CEO dinners, happy hours, science days, university-MedImmune scientific meetings to identify collaboration opportunities and build MedImmune's presence in key biotech hubs * Expected to very much to be a "hands on role" i.e. able to work independently but with the ability to lead a matrix group and/or to proactively and meaningfully participate in other group led discussions. * Complete transactions and negotiations for research and clinical collaborations * To be up to date with the latest science and literature and to be able to engage in the science with our scientific teams * Travel up to 25% of time Education: BA or BS required, MBA or another advanced degree (e.g. MS, PhD) strongly preferred, Science based degrees preferred, priori related experience preferred. ~BSP *LI-MEDI

Posted On - 8/19/2014 7:05:19 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 - 8/19/2014 7:05:19 AM

Post Doctoral Fellow - Oncology

Gaithersburg MD

Position: *Doctoral and/or Post-Doctoral research; demonstrated ability to conduct a high level research project *Hands on skills in cellular and molecular techniques including cell culture, use of primary tissues and cells, RNA isolation, PCR, cell transfection/transduction, cell growth/apoptosis assays, cell transformation, ELISA, and western blot *Hands-on in vivo experience and familiarity with multiple in vivo cancer models *Specific experience with pancreatic and lung cancers preferred but not required Education: PhD with experience in cell biology, cancer biology, or closely related field

Posted On - 8/19/2014 7:05:19 AM

Senior Clinical Scientist

Gaithersburg MD

Required Experience & Skills: * Approximately 2-6 years of progressively responsible clinical research experience, or demonstrated ability to develop clinical research protocols and effectively manage clinical trials and clinical development plans, preferably in the therapeutic area of immunology and autoimmune diseases. * Demonstrated ability to work in cross-functional teams and with individuals. * Global pharmaceutical experience is desired. * Demonstrated ability to develop and manage/execute clinical research protocols. * Effective verbal and written communication skills and ability to relate to colleagues and associates at all levels both inside and outside the organization. Education: * PhD, or Masters degree in heath science field, PharmD, MD, or other relevant advanced degree in a health science field is preferred. *LI-MEDI ~BSP

Posted On - 8/19/2014 7:05:19 AM

Senior Statistician/Principal Statistician

Gaithersburg MD

Education: For the Senior Scientist position: MS in statistics or other related field with high statistical content and 0 - 6 years experience or Ph.D. in statistics or other related field with high statistical content For the Principal Scientist position: MS in statistics or other related field with high statistical content and 6 - 9 years experience or Ph.D. in statistics or other related field with high statistical content and 3-6 years experience Position: * industry experience in drug research and development environment * Complete understanding and wide application of statistical methods and applications * Experience in regulatory interactions and BLA/NDA development and submission * Excellent SAS programming skills and experience with other study design and analysis software * Effective oral and written communication and interpersonal skills

Posted On - 8/19/2014 7:05:19 AM

Director, R&D Strategic Planning/Sr. Director, R&D Strategic Planning

Gaithersburg MD

Required Education & Experience: * For the Sr. Director level, we require that candidates have previous experience in strategic management consulting and demonstrate a very strong experience within drug discovery and clinical development, with an emphasis on biologics heavily preferred. For both levels we require the following: * Advanced degree or equivalent work experience required; MBA, Ph.D. or equivalent preferred * At least eight to ten years of experience in a fast-paced development setting, preferably biotechnology, with experience in business planning, operations, strategy and clinical development * Demonstrated ability to oversee and co-ordinate multiple projects and/or alliances that are running concurrently * Sophisticated demeanor, bearing and approach sufficient to position the incumbent for interaction with senior level executives in delivering effective presentations and providing high-level information to influence major decisions at the highest level * Excellent stakeholder management skills and ability to develop strong relationships with senior leaders and other key stakeholders * Excellent management and matrix team leadership skills that include the ability to provide direction and lead multi-disciplinary teams on highly collaborative efforts resulting in successful implementation * Willingness and proven ability to function in a hands-on capacity when necessary to achieve milestones, resolve issues and build an organization/function capable of driving toward measurable objectives * Proven ability to drive projects forward to a successful conclusion in a matrixed, organization; * High level of maturity that includes judgment, discretion, self-motivation, accountability, plus the ability to accept responsibility * Broad business perspective and acumen, goal-oriented approach, process orientation and strategic focus * Ability to thrive in an environment that often involves a high degree of ambiguity * Strong analytical approach, keen organizational capability and solid time management skills.

Posted On - 8/18/2014 7:05:27 AM

Lead Document Specialist

Gaithersburg MD

Educationakl Requirements: * Bachelor's degree or higher Required Skills/Experience: * 10-12 years of industry experience in electronic document management systems * Expert knowledge and experience in Documentum/First Doc functionality, policies, procedures and processes * Expert knowledge in Microsoft Word package and software * Expert knowledge of regulatory documentation and submissions globally * Experience in working with geographically diverse global teams * Demonstrated ability to develop innovative and effective solutions to problems of high complexity Desired Experience: * Experience in system administration for validated applications within a regulated environment. * Knowledge of the drug development process Competencies: * Demonstrate excellent interpersonal skills and build relationships across functions and disciplines to deliver a quality service * Demonstrate excellent communication skills with all levels of the organization, including Sr mgmt. * Demonstrate strong ability to deal with ambiguity and manage conflicts * Excellent Presentation skills * Learning on the fly * Customer focus * Good organizational skills

Posted On - 8/18/2014 7:05:27 AM

Supervisor, Pilot Production - Support Services

Gaithersburg MD

Education: Must have at least a B.S. degree in the sciences. Position: Seven or more years experience in a large-scale biotechnology manufacturing environment. * Prior supervisory experience. * Must have prior cGMP experience. * Experience working with production equipment such as washers, autoclaves, filtration devices, etc. * Experience weighing materials, working with large scale fixed tanks, CIP / SIP activities, and performing SOP revisions. * Must have good interpersonal skills and be attentive and approachable. * Must have ability to act as a mentor for less senior personnel, and to actively work to develop subordinates within the organization. *LI-MEDI

Posted On - 8/18/2014 7:05:27 AM

Associate Director, Clinical Operations

Gaithersburg MD

Required Experience: * Preferred twelve years of experience in the pharmaceutical industry. Preferred that six of those years were 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. Required 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. Required Skills/Abilities: * Requires minimal guidance and oversight from the Therapeutic Area Director (TAD). * oStrategic 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 - 8/15/2014 7:27:44 AM

Clinical Operations Project Manager/Sr. Clinical Operations Project Manager

Gaithersburg MD

Required Experience: * Minimum of 8 years progressive experience in clinical operations including site management and monitoring or equivalent and at least 3 years of program management experience or equivalent Required Skills and Abilities: * Thorough understanding of country level regulations, ICH and GCP guidelines * Thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs * Demonstrate ability to lead a cross-functional team in a matrix environment * Strong interpersonal and negotiation skills * Strong verbal and written communications and presentation skills * Proven problem solving and decision making skills * Strong leadership, communication, management and organizational skills, conflict resolution, and team building skills. * Potential to line manage personnel * Ability and willingness to travel 25% of the time (international and domestic) Education: * University degree

Posted On - 8/15/2014 7:27:44 AM

Director, R&D - Toxicology

Gaithersburg MD

Education: Ph.D. in toxicology or closely related discipline with specialization in immunology/translational biomarkers or related field. Position: * At least 10 years of experience with a minimum of 7 years experience in Biotech-Pharma industry in leading/managing drugs targeting immune system. * The candidate must have a strong record in filing INDs, BLAs etc. * Must have a strong understanding of biologics drug development, oncology, inflammatory, respiratory and infectious diseases, and animal models of diseases and translational aspects of the drug development. * Strong leadership and effective management skills * Innovative, creative and able to influence others in a positive manner * Strong communication, organizational and interpersonal skills to work in matrix setting, manage projects and team members in a matrix environment. * Problem solving and organizational skills with attention to details related to drug development.Strong team player and strong motivational skills. *LI-MEDI

Posted On - 8/15/2014 7:27:44 AM

Principal Scientist / Fellow

Gaithersburg MD

Education and Experience: For Principal Scientist: MD, PhD/MD or PhD degree in a relevant scientific field (e.g. molecular biology, cell signaling, computational biology) Minimum of 10-15 years post-MD/PhD experience in an academic and/or industry setting For Fellow: MD, PhD/MD or PhD degree in a relevant scientific field (e.g. molecular biology, cell signaling, computational biology) 15 + years post-MD/PhD experience in an academic and/or industry setting Position: *Outstanding record of innovative contributions to translational sciences in respiratory disease particularly COPD as evidenced by a strong publication record including first / senior-authored publications in top-tier journals, inventorship on crucial patents/filings and presentations at important conferences are a must for this role *Ideally, experienced in analyzing large datasets including genomic and proteomic together with a sound understanding of critical development functions, e.g. Clinical Sciences, Biomarker Development, Translational Medicine *Prior experience managing a group of research associates, scientists, managers, etc would be ideal *Outstanding verbal and written communications skills are a must. * Ideally, experienced in analyzing large datasets including genomic and proteomic together with a sound understanding of critical development functions, e.g. Clinical Sciences, Biomarker Development, Translational Medicine *LI-MEDI

Posted On - 8/14/2014 7:01:32 AM

R&D Associate I / R&D Associate II

Gaithersburg MD

Education: R&D Associate I Bachelor's Degree and 0-2 years of releveant experince R&D Associate II Bachelor's Degree and 2-5 years of relevant experience OR a Master's Degree with 0-2 years of relevant experience Position: Required skills: Aseptic techniques, microbial culture experience, mammalian cell culture experience, chemical and biochemical engineering principles, hands on experience operating fermentors and/or bioreactors and scaling processes from bench to production. Excellent communication skills are also considered a must. Desirable Skills: The use of statistical data analysis and design. Media development, experience with large scale fermentor and bioreactor operations, familiarity with cGMP manufacturing principles involving fermentation and inclusion body harvests is desired. Familiarity with E. coli, CHO and other microorganisms is sought. Working knowledge of the Nova BioProfile, YSI, ViCell, BGA and spectrophotometer operations are considered a plus. Must be able to handle multiple operations and thought streams at the same time. Several experiments with varied run conditions will be operating simultaneously along with ancillary support of analytical data gathering and seed train maintenance. Due to the nature of fermentation & cell culture work, consistent off-hours work will be expected. Dedicated, hard working individual sought for this position.

Posted On - 8/14/2014 7:01:32 AM

Senior Project Manager

Frederick MD

Position: Ability to apply expertise as a project manager within the biopharm industry to successfully deliver project and program outcomes while managing stakeholder expectations. Has knowledge of project management tools including schedules, communication plans, risk plans, resource plans, scope management tools, action item trackers, and project plans. Maintains high level of expertise in the field of project management and the biopharm industry through review of current scientific, professional and business literature, and attendance and participation at professional. Education: BS required, Masters preferred. Science degree (chemistry, biology, engineering, pharmacy) preferred. PMP, CCP or similar certification preferred. Minimum of 8 years experience in pharma/biologics and 8 years of project management experience required. *LI-MEDI

Posted On - 8/14/2014 7:01:32 AM

Utility Operator II

Frederick MD

Position: * Knowledge of Utility and facility equipment such as HVAC, refrigeration, boiler, chiller, cooling tower, pumps & drives, RODI, WFI, and clean steam systems. Full knowledge of all aspects of mechanical maintenance required for these systems. * Experience performing mechanical maintenance activities such as valve rebuilds (diaphragm, ball valves, gate valves, proportional control valves), pump rebuild including seals (positive displacement, air pumps, peristaltic, and centrifugal pumps), agitator maintenance including seal replacements, motor pump replacement/alignment, and heat exchanger repairs. Full knowledge of all aspects of mechanical maintenance required for these systems. * Working knowledge of Bio processing equipment such as bio-reactors, washers, autoclaves, WFI systems, RODI and Clean Steam systems. * Capable of taking equipment logs, responding to BMS alarms as well as performing work in the mechanical, pipefitting, or plumbing trades. * Detail oriented and be able to complete any required (GxP) documentation in a timely manner, including logbooks and work orders. * This position requires work from elevated work platforms, ladders and in confined spaces using trade related tools and equipment. * May also be required to lift 50 pounds in execution of job duties. * Willing to work nonstandard, 12hr Daylight shift which includes Saturdays. Required Skills/Experience: * Use basic hand tools. * Must be able to read, write and utilize drawings, mathematics, handbook formulas. * Read mechanical schematics and piping diagrams P&ID's * Must be able to work in a clean room environment. * Candidate must possess basic computer skills * Must have ability to communicate both orally and written in a clear manner * Limited supervision. No instructions needed on routine work and general instructions given on new lines of work or special assignments. * Considerable knowledge of the job. Complete acquaintance with and understanding of the general and detailed aspects of the job, and their practical applications to problems and situations ordinarily encountered Education: High School diploma, technical school, Or Military training and experience in relevant field required 3 to 10 years in a plant or equipment maintenance preferred Preference will be given to biotech/pharmaceutical experience.

Posted On - 8/14/2014 7:01:32 AM

R&D Associate II

Gaithersburg MD

Education: Bachelors of Science Degree in Chemistry, Biology or related with 2 - 5 years experience Masters of Science Degree in Chemistry, Biology or related with 0 - 2 years experience Position: - The candidate must have experience working with monoclonal antibody related HPLC/GC impurity and excipient assays. - The candidate must have excellent oral communication skills, good time management and outstanding multi-tasking abilities, and a fast-paced team-centered setting. - The candidate has experience writing SOP and technique reports - The candidate has ability to make detailed observations, analyze data, and interpret results with minimum supervision. - Experience in developing and optimizing HPLC/GC impurity and excipient assays will be a plus - Experience in ELISA, Gyrolab, and PCR area will be a plus. - Experience with HPLC, and GC assay development and optimization in biological area. - Experience working in Biopharmaceutical Company - Excellent writing and oral communication skills - Good time management and outstanding multi-tasking abilities - Team player *LI-MEDI

Posted On - 8/13/2014 7:05:49 AM

Senior Director, Clinical Development/Director, Clinical Development

Gaithersburg MD

Required Experience and Knowledge: * Prior experience in clinical research design/implementation of protocols, review/interpretation of data is required. This could be obtained through prior work in the pharmaceutical industry, Regulatory, or academic clinical research. * Must demonstrate knowledge of the clinical development process and have direct clinical research and managerial experience. * Knowledge of clinical trial management, data management, and drug development process. * A detailed understanding of human disease, pharmacology, biochemical medicine and the relevance of pharmacodynamic/clinical endpoints that underlie the action of the drug(s) being developed. * A fellowship or training and certification in Oncology are desirable. * Clinical or research experience in field of specialization is highly desirable. * Five or more years of industry related experience is desirable. Education: * MD with a valid medical license. * Medical specialty and sub-specialty training and certification are highly desirable in Oncology. * A fellowship or training and certification in Oncology are desirable.

Posted On - 8/13/2014 7:05:49 AM

Quality on the Floor

Philadelphia (Non Sales) PA

Position: * 1-2 years of experience in biopharmaceutical/pharmaceutical industry. * Experience in aseptic processing * GMP experience in QA role * Bachelor of Science in Biology, Chemistry, Engineering, or related fields is preferred. Education: Bachelor of Science in Biology, Chemistry, Engineering, or related fields is preferred. ~BSP *LI-MEDI

Posted On - 8/11/2014 7:07:15 AM

Scientist II - Nanoparticles

Gaithersburg MD

Education: * Ph.D. with 4 or more years of experience in the area of nanoparticles or in their application to a biological field of study; background in cell biology Position: * Demonstrated knowldge and achievements in the use of nanoparticles * Ability to quickly assimilate new, unfamiliar areas and apply them to area of work * Interaction with therapeutic areas to test and develop our strategy * Ability to identify and build the relevant cell based systems to test activity of nanoparticles * Work with academic collaborators to advance our knowledge of the NP field and use of internal assets * Knowledge of the drug discovery and development process would be helpful * Protein engineering skills would be a bonus * Strong interpersonal skills that allow productive interactions across departments, MedImmune global sites, and business and legal teams * Execellent written and verbal skills * Good publication record with the motivation to continue to publish and present work at external conferences

Posted On - 8/11/2014 7:07:15 AM

Senior Director, Clinical Quality

Gaithersburg MD

Required Experience and Skills: * 10-15 years of global clinical operations experience is preferred with a minimum of 5 years of document and process QC and/or QA. * Demonstrated experience in performing and assessing QC of documents and processes and in documenting the results of these assessments. * Knowledge of current GCP guidelines and regulations, including ICH guidance and other regulatory requirements regarding clinical documents. Required Education: * BA or BS degree (or higher) in biologic or related scientific discipline. *LI-MEDI ~BSP

Posted On - 8/11/2014 7:07:15 AM

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