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Company Jobs - MedImmune


 

Senior Project Manager

Gaithersburg MD

Your previous experience will include: For the Senior Biologics Project manager level, we require a minimum of 8 years of Project Management experience in a BioPharma Product Development environment. For the Biologics Project Manager level, we require a minimum of 5 years of Project Management experience in a BioPharma Product Development environment. Product Development Process * Understands overall biologic/pharmaceutical product development process, including stages of development and role of different functional areas. * Working knowledge of the biological sciences with technical, scientific or medical expertise in one or more functional areas involved in pharmaceutical/biologic product development. * Early and late phase clinical development stages and processes and decision criteria for moving programs through the development pipeline, and the considerations relevant to post-marketed development and life cycle management. * Core cross-functional concepts (e.g., preclinical, translational, CMC) and major requirements at different development stages. * Basic knowledge of worldwide regulatory requirements, processes and regulatory authority interactions, as well as patent protection and records management. * Commercial valuation, product life cycle planning, pricing and health economics. Project Management * Ability to create, coordinate, and maintain an integrated product plan and to control or respond to changes in strategy and scope. * Expertise in use of project management software solutions, including skills in critical path analysis. MS Project and/or Planisware experience is a plus. * Understanding financial and resource planning systems and processes and ability to coordinate project-level budget/resource estimates and manage actuals vs. plan. * Ability to manage teams and individuals in a matrix environment, ability to track team performance against objectives, use of effective meeting management tools and techniques, and knowledge of decision-making and conflict resolution techniques. * Ability to maintain sources of project information, and to integrate and distribute appropriate information to senior management and team members. * Able to negotiate with team members to resolve project/team issues. Education BA/BSc in a biological science or equivalent is required. An advanced degree (e.g., MBA, MS) is preferred

Posted On - 7/22/2014 7:15:40 AM

Lead Document Specialist

Gaithersburg MD

Required Skills/Experience: * Bachelor's degree or higher with 6-8 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 * Basic knowledge of regulatory documentation * Experience in working with geographically diverse global teams * Demonstrate ability to develop effective solutions to problems of high complexity 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 * Excellent Presentation skills * Learning on the fly * Customer focus * Good organizational skills Desirable: * Experience in system administration for validated applications within a regulated environment. * Knowledge of the drug development process

Posted On - 7/22/2014 7:15:39 AM

Sr. Statistical Programmer Analyst/Project Lead, Statistical Programming

Gaithersburg MD

Position: For Project Lead: A minimum of 8 years of clinical trial programming experience using SAS within pharmaceutical, biotechnology, and/or contract research organization industries. For Sr. Statistical Programmer Analyst: A minimum of 5 years of clinical trial programming experience using SAS within pharmaceutical, biotechnology, and/or contract research organization industries. Education: Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field. Advanced degree in Statistics preferred. *LI-MEDI ~BSP

Posted On - 7/21/2014 7:23:26 AM

Supervisor, Packaging

Philadelphia (Non Sales) PA

Position: Qualifications/Experience *Knowledge of FDA cGMP's *Strong communication and leadership skills *Strong problem solving skills *Strong technical writing skills with ability to author SOPs and deviations *Proven ability to lead operational teams *Must have the ability to work shifts and overtime as required *Ability to lead/participate in cross-functional teams *Competent with MSOffice applications Preferred Experience *3 years progressive packaging experience *2 years prior supervisory or management experience *5 years experience in cGMP or regulated production environment *Experience working in a Lean Manufacturing Environment *Knowledge or previous experience in managing technical programs/projects *Preferred SAP experience or other ERP systems and Trackwise *Green Belt certification or equivalent Lean Enterprise certification Education: Educational Requirements *Degree in Engineering, Pharmaceutical, related Life Science or Business *Master's degree with 2 yrs. work experience in cGMP manufacturing environment *Bachelor's degree with 5 yrs. work experience in cGMP manufacturing environment OR *Associates degree with 10 yrs. experience in cGMP manufacturing environment *High School Graduate with 15 yrs. experience in cGMP manufacturing environment

Posted On - 7/21/2014 7:23:26 AM

Quality Engineer III

Gaithersburg MD

Position: Minimum 3 years in biotechnology related industry or medical device industry. Preference for previous experience with combination products. Prefered experience 5+ years. Desired certifications: ASQ CQE/CQA. Education: Bachelors in Engineering (preferably checmical or mechanical)

Posted On - 7/18/2014 6:57:24 AM

Associate Scientist I/II

Gaithersburg MD

Position: This position is primarily laboratory-based. Due to nature of cell culture experiments, occasional weekend and holiday work may be required. Education: Bachelor or Master of Science in chemical/ biochemical/ biomolecular engineering or related science disciplines. Relevant experience of 5 to 8 years with a Bachelor's degree and 2 to 5 years with a Master's degree is required for Associate Scientist I position. Relevant experience of 8 to 10 years with a Bachelor's degree and 5 to 8 years with a Master's degree is required for Associate Scientist II position. *LI-MEDI

Posted On - 7/17/2014 7:05:07 AM

Brand Leader, Immune Mediated Therapies

Gaithersburg MD

Requirements/Qualifications: Essential : * Bachelors degree * Expertise & experience in oncology * Understanding of the development process and necessary commercial touch points * Thorough understanding of general business and core marketing principles and application to future healthcare market challenges * Strategic thinking, judgment and influencing skills, to develop and implement strategies * Strong leadership attributes to generate commitment and constructively resolve issues * Proven experience and knowledge of a broad base of external customers including patients, prescribers, payers, and providers. * Evidence of developing compelling Business cases * Sufficient understanding of technical risks and the implications for the commercial aspects to future brands * Sufficient understanding of key marketing skill sets Desirable: * Relevant technical degree * MBA * Broad commercial experience * Global commercial experience * Inline Brand Marketing Company experience * Exposure to decision-making bodies * Working with R&D and other non marketing functions Leadership Capabilities * Strategic Leadership: ability to assess - and build commitment to - current and future needs based on analysis of risks, opportunities and priorities * Acts decisively and independently: has confidence and ability to provide clear direction and make decisions (strategic & tactical) without guidance or affirmation (but knows when to inform/seek leadership buy-in) * Leadership influence: able to engage and constructively challenge others across all leadership levels * Customer-focused: ability to consider many customers' (internal and external) needs while able to take a bigger picture view BSP

Posted On - 7/17/2014 7:05:07 AM

Internal Audit and Risk Manager

Philadelphia (Non Sales) PA

Position: * Minimum of 7 years of experience in the Biopharmaceutical/pharmaceutical industry, with at least: o 5 years of experience working in a GxP site operations (QA/QC preferred) o 3 years of experience working in direct support of Biologics/Biopharmaceuticals o 3 years of experience in sterile manufacturing and/or Packaging operations setting * Advanced skills in planning and executing audits to identify significant risks and non-compliance situations (ASQ or equivalent audit certification is preferred) * Fully versed in the interpretation and application of cGMP requirements and expectations * Proficient with risk management processes, tools and standards * 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 * Familiarity with Operational Excellence tools and techniques is preferred. Education: Bachelor of Science in biology, chemistry, engineering or related fields is required. *LI-MEDI

Posted On - 7/17/2014 7:05:07 AM

Manufacturing Coordinator

Philadelphia (Non Sales) PA

Position: 0-2 years with Bachelors's degree 2-4 years with high school diploma or general education degree (GED) Education: Hich school diploma or general education degree (GED) Bachelor's degree preferred.

Posted On - 7/17/2014 7:05:07 AM

Pilot Production Technician II

Gaithersburg MD

Required Education and Experience: * Preferred bachelors degree in the sciences with 1 - 3 years of relevant experience. * AA or BS Degree is heavily preferred. * Proficient in the operation of all area specific production equipment such as Autoclaves, GMP Glass washers, filtration devices, scales, analytical equipment, etc. * Proficient at multitasking * Knowledge of basic production equipment (tanks, scales, meters, transfer panels) * Knowledge of clean room regulatory requirements * Knowledge of cGMP Principles and Standards * Knowledge of Solution Prep and Transfer * Knowledge of SAP *LI-MEDI ~BSP

Posted On - 7/17/2014 7:05:07 AM

QA Specialist IV

Louisville South KY

Position: * Minimum of six years of experience in the Biopharmaceutical/pharmaceutical industry. * Minimum of four years experience in quality assurance, quality control or validation. Education: * Bachelor's degree in biology, chemistry, engineering or other relevant field is required. *LI-MEDI

Posted On - 7/17/2014 7:05:07 AM

R&D Associate I/II

Gaithersburg MD

Education: Bachelor or Master of Science degrees in chemical/ biochemical/ biomolecular engineering or related science disciplines. RA I: * Bachelor's degree with 0 - 3 yrs; * Masters degree with 0 - 3 yrs RA II: * Bachelor's degree with 3 - 6 yrs (5yrs ideal); * Masters degree with 0 - 3 yrs (please note that PhDs and MDs are considered to be over-qualified for this job opening). Requirements: * A high degree of proficiency in MS Office (or related) programs such as spread-sheet programs and data analysis is required. * A good understanding of biochemical engineering concepts, biochemical pathways, and/or biochemistry is required. * Excellent team work, communication skills and trouble-shooting abilities are also considered a must. * Must be willing to work weekend as well as off-hours work due to the nature of cell culture and fermentation work. Preferences: * Experience with aseptic techniques, mammalian cell culture and running bioreactors is preferred but not required. * Additional desirable skills include medium development, knowledge of Design of Experiments and statistical data analysis. ~BSP *LI-MEDI

Posted On - 7/17/2014 7:05:07 AM

Scientist I

Gaithersburg MD

Position: 2 or more years of solid post-doctoral training in immune receptor signaling, the tumor immune micro-environment and/or inflammation/ angiogenesis and a publication record in these fields. Education: PhD preferred, degree in Immunology required. *LI-MEDI

Posted On - 7/17/2014 7:05:07 AM

Associate, Patient Access

Gaithersburg MD

Position: * Min 3 years healthcare/healthcare reimbursement experience; proficiency in all aspects of reimbursement, i.e., benefit investigations, private and public payor reimbursement policies and procedures, regulatory and administrative rules, etc is required * Healthcare/reimbursement Case Management experience * Expert knowledge of reimbursement and patient assistance programs: operational policies and processes * Proven track record for consistently meeting or exceeding qualitative, as well as any relevant quantitative, targets and goals * Business travel, by air or car, is required for regular internal and external business meetings Preferred: * Relevant healthcare/ insurance experience with biologics * Billing/ Coding background in buy and bill and Specialty Pharmacy markets * Social work background Education: Bachelors degree or greater (health sciences, managed healthcare, public policy, social worker or related disciplines are preferred)

Posted On - 7/16/2014 7:39:10 AM

Automation Engineer II/III

Frederick MD

Position: Position Requirements: Knowledge of PLC's, GMP's, S-88 Batch, database development and maintenance, Osi Pi, control loop tuning, HMI/SCADA programming including VBA, Ethernet switching and VLans, Server OS and management, sever and storage virtualization, strong troubleshooting skills, mechanical knowledge. Excellent process, communication and teamwork skills are vital. Experience with DeltaV, Allen Bradley Logix 5000 PLCs, Rockwell RSView SE SCADA systems, SQL Databases, VMWare, Cisco, and NetApp storage preferred. Physical Demands: Noise level: Quiet Vision Requirements: Ability To Adjust Focus Lifting Limits: Up to 50 lbs Work Environment: Percentage of Time: Standing: 26-50% Walking: 51-75% Sitting: 51-75% Hand Use: 0 - 25% Hand Reaching: 0 - 25% Stooping or Crouching: 0 - 25% Talking and Hearing: 76-100% With Mechanical Moving Parts: 0 - 25% Working With Risk of Electrical Shock: 0 - 25% Education: Bachelors: Electrical Engineering, Computer Science, or a related degree with 3-5 years relevant automation engineering experience.

Posted On - 7/16/2014 7:39:10 AM

Senior Patent Agent

Gaithersburg MD

Position: *3-5 years patent prosecution experience in-house and/or law firm Education: * Licensed to practice before the USPTO * Licensed US Attorney (IP Counsel) * Ph.D. or equivalent, and/or several years of laboratory experience in relevant scientific area

Posted On - 7/16/2014 7:39:10 AM

Associate Scientist II/Scientist I

Gaithersburg MD

Position: Experience requirements: * Extensive experience with flow cytometry and flow sorting including sterile single cell deposition sorting * Experience in cell biology, including mammalian cell culture. * Excellent sterile technique. * Excellent quantitative, technical writing and oral presentations skills * Ability to maintain careful and timely documentation of all activities * High level of scientific curiosity. * Excellent problem-solving skills. * Strong focus on details and results. * Experience in biotherapeutic manufacturing cell line development a plus. * Experience in immunology a plus. * Experience with robotics, high-throughput processes and automated data management a plus. Educational requirements: For Associate Scientist II: M.S. degree in cell biology, immunology or related discipline plus 5-8 years industry experience, or B.S. degree in one of the above areas plus 8-10 years industry experience. For Scientist I: Ph.D. in cell biology, immunology or related discipline for 0-3 years, or M.S. degree in one of the above areas plus 8-10 years industry experience, or B.S. degree in one of the above areas plus 10-13 years industry experience. *LI-MEDI

Posted On - 7/15/2014 7:05:48 AM

Medical Affairs Leader - Diabetes

Gaithersburg MD

Experience, Functional Knowledge, Business Knowledge, Education, Specialist Skills: * Medical degree of appropriate certification (MD , DO or equivalent) * Practical/ working knowledge of the Brand and Disease Area, in this case, diabetes * Demonstrated experience in developing medical strategies and plans * Experience with global OL engagement Skills and Capabilities * Patient-centered but commercially aware, values driven approach * Level 3 leadership capabilities * Demonstrated project management skills to lead cross functional teams * Ability to translate data into a strategic medical plan * Proven ability to engage, influence and build effective relationships with OLs, across functional and geographic boundaries * Strong verbal and written communication skills in English * Broad understanding of more than one part of the business i.e. Discovery, Clinical, Regulatory, Medical or Commercial roles * Presentation and influencing/negotiation skills (essential) * High ethical standards required Internal Contacts/Customers * GMA Leadership Team: TAVPs, VP Evidence Centre VP Medical Excellence, Exec Director Operations * Global Product Team (GPT) members * The Medical Working Groups (MWGs) -Medical Science Director (MSD) -Global Payer Evidence Directors (GPED) -Key marketing company medical leaders * The Medical Evidence Center (MEC) -Medical Evidence Directors (MED) and Leaders (MEL) -Global Publications Leaders (GPLs) -ESRO TA Directors * The Global Medical Excellence Team (GME) -Dir MSL Program -Sr Dir Medical Information -Dir Medical Academy -Nom Sig Director -GMQA Leader External Contacts/Customers * In-country Medical Teams * Regional Medical Directors * International/global opinion leaders * Leadership of International Medical Associations * Academic Institutions/Hospitals * Medical opinion leaders in Policy, Payer and HTA environment * Peers in the Industry Reporting Relationship * No direct line management/reports Budget responsibility * Responisble for the creation, delivery and management of an annual Brand Medical Budget that is aligned with GMD or GPPS budget processes (depending on the life-cycle of the product/brand) Measure of Success * Supports the successful development and medical marketing of AZ brands that deliver patient-centric medical value * Delivery of fit-for-purpose Medical Strategies and plans that include Medical Evidence Plans, which are delivered by the Medical Evidence Directors * Adds value internally, evidenced by positive feedback from TAVP, GMA LT, members of the MWG, GBTs, GPTs and all other stakeholders * Enhances the reputation of AZ in all meetings with external stakeholders, as evidenced by positive feedback from international OLs * Creates content and delivers insight for a curriculum that drives internal Medical content and capabilities training across AZ, that improves the performance of recipients

Posted On - 7/15/2014 7:05:48 AM

Pilot Production Technician II/Pilot Production Technician III

Gaithersburg MD

Required Education and Experience: * For the Pilot Production Tech III we require a high school diploma with a minimum of 3 - 5 years of relevant experience. * For the Pilot Production Tech II we require a high school diploma with a minimum of 1 - 3 years of relevant experience. * For both levels, an Associate's Degree or a BS Degree in a scientific discipline are havily preferred. * Proficient in the operation of all area specific production equipment such as bioreactors, centrifuges, filtration devices, chromatography equipment, washers, autoclaves, etc.. * Reviews and provides feedback about Master Production Records and Solution Production Records (SPRs) to authoring group, as needed, to accurately reflect process steps and capture process changes. * Authors and edits Standard Operating Procedures (SOPs). * Assists in the planning, identification, ordering and set-up of basic equipment. * Assists in the execution of validation protocols, as requested. * Collects and distributes in-process cGMP samples. * Provides training to more junior staff, as requested. * Performs first-line troubleshooting and root cause analysis. * All tasks and activities of the Level 1 Technician. ~BSP

Posted On - 7/15/2014 7:05:48 AM

Technical Engineer/Sr. Technical Engineer

Gaithersburg MD

Required Education & Experience: * For the Technical Engineer level, we require BS degree with 4-6 years related experience or MS degree with 2-4 years experience. * For the Sr. Technical Engineer level, we require BS degree with 6-8 years related experience or MS degree with 4-6 years experience. * Bachelor's/Master's degree required in Computer Science, Bio/Chemical Engineering, Biotechnology, Chemistry, or Biology. * Certification in Lean Six-Sigma and/or project management practices is a plus. * Demonstrated technical proficiency in database architecture, programming (e.g. .NET, C#, Java, C++), and UI design is required. * Prior knowledge of scientific instrumentation and past hands-on experience at least within one biopharmaceutical R&D area is preferred. * Experience with a LIMS and/or an Electronic Laboratory Notebook, and integration of systems is preferred. Presentation skills: * Ability to both prepare clear presentations and deliver them to different audiences with confidence including in a training environment. Demonstration of systems: * Ability to communicate information system functionality clearly, to answer any questions and to receive user feedback as necessary. Written communications: * Ability to compose concise and well formatted communications in the form of project charters, project review documents, work instructions/SOP's, and information e-mails to wide audiences. Technical Knowledge: * Database and/or programming background. Hands-on laboratory experience in some capacity (analytical methods, process development, technology transfer, formulation development) in the past. * Knowledge of database design and function such as SQL or Oracle, and programming tools such as C# or similar are required. *LI-MEDI ~BSP

Posted On - 7/15/2014 7:05:48 AM

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