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Company Jobs - MedImmune


 

Co-op, Validation

Philadelphia (Non Sales) PA

Required Education and Experience: * Prior participation in a collegiate co-op or intern program. * Pursuing B.A. or B.S. at an accredited college or university.

Posted On - 7/30/2014 7:23:22 AM

Manager - SHE

Frederick MD

Position: Minimum 3+ years of experience in environmental management, managing projects and / or programs with demonstrated knowledge of environmental regulations; experience in pharmaceuticals, biotechnology or related field are preferred Education: Bachelors degree in Environmental Science / Engineering, Biology, Chemistry, Physics, or similar field *LI-MEDI

Posted On - 7/29/2014 7:10:17 AM

Manufacturing Scientist I

Frederick MD

Requires: Ph.D. degree in Biochemical Engineering, Biochemistry, or a closely related field, plus 2 years of industry experience. MedImmune, LLC, One MedImmune Way, Gaithersburg, MD 20878. To apply for this position, please visit www.medimmune.com/careers and search for Requisition #i115.

Posted On - 7/28/2014 7:32:27 AM

QC Analyst

Frederick MD

Position: * Be able to plan and carry out laboratory operations efficiently and effectively. * Critical thinking and attention to details required * Must be able to maintain accurate records of all experiments and data. * QC or GMP experience is a plus. * Must be a team player and customer oriented. * Candidate will be working under supervision but level of independence should increase with time. * Self-motivated. Multi-tasking, excellent written and oral communication skills desired. Education: Bachelors Degree: Scientific / Biotech / Pharmaceutical field of study, preferred 0-5 years experience. ~BSP *LI-MEDI

Posted On - 7/28/2014 7:32:27 AM

Quality Assurance Process Engineer

Frederick MD

Position: * 8-15 years in a highly regulated biotechnology environment, including experience in development, manufacturing, or quality control. * Previous experience in Quality Assurance is preferred. * Experience with mid/large scale monoclonal antibody production for clinical and commercial product. * Ability to deal with ambiguity, influence without authority, and stand alone. * Ability to use logic and methods to solve difficult problems with effective and efficient solutions. * Experience with OE methodology to solve problems and improve efficiency. Education: BS, MS, or PhD in biological sciences, biochemical engineering, or biotechnology related field required. ~BSP *LI-MEDI

Posted On - 7/28/2014 7:32:27 AM

R&D Associate I

Gaithersburg MD

Position: * Understanding of biochemical engineering, biochemistry and biotechnology is required. * Experience with aseptic techniques, mammalian cell culture and running bioreactors is preferred. * Additional desirable skills include medium development, knowledge of Design of Experiments and statistical data analysis. * This position is primarily laboratory-based. * Due to the nature of cell culture and fermentation work periodic weekend as well as off-hours work will be expected. * A good understanding of biochemical engineering concepts, biochemical pathways, biochemistry, biotechnology and proficiency in MS Office (or related) programs is required. * Experience with mammalian cell culture is preferred. Excellent team work, communication skills and trouble-shooting abilities are also considered a must. Education: For Research Associate I level: * Bachelor degree in chemical/ biochemical/ biomolecular engineering or related science disciplines with 0 to 3 yrs of relevant experience is required. For Research Associate II level: * Bachelor's degree in chemical/ biochemical/ biomolecular engineering or related science disciplines with 2 -- 5 yrs or Masters degree with 0 to 3 yrs of relevant experience is required.

Posted On - 7/28/2014 7:32:27 AM

Senior Manager, Training

Gaithersburg MD

Position: 5-7 years in the pharmaceutical industry or related area with 2-4 years of training experience in a GXP-regulated environment. Strategic experience with senior leadership team level clients, strong decision making capability and comfort in a manufacturing setting. Strong leadership and management experience with ability to work in a matrix and global environment. Education: Bachelors: Biological Sciences, Psychology, or Education. Masters is a plus. *LI-MEDI

Posted On - 7/28/2014 7:32:27 AM

Director, Clinical Sample Logistics

Gaithersburg MD

Required Experience and Education: * 15 years of related experience * M.S. in Biological Sciences or equivalent experience required * Experience in establishing methodologies and tools used to track clinical samples and coordinating transfer of testing data between internal and external laboratories * Must have experience working in a laboratory setting with sample management capacity and be familiar with the entire sample management life cycle * Prior experience in leading cross-functional teams and managing stakeholders at all levels * Strong knowledge of GCP and GLP compliance Required Skills and Abilities: * Excellent communication skills with the ability to manage multiple stakeholders throughout the organization * Demonstrated ability to lead cross-functional teams in a fast-paced environment * Ability to build strong processes and tools capable of delivering world class sample management systems * Must possess strong organizational and analytical skills * Demonstrated ability to plan and implement multi-faceted approaches to address organizational needs * Strong time-management, project planning and priority management skills

Posted On - 7/25/2014 7:21:35 AM

Senior Scientist / Principal Scientist (Drug Product Analytics and Characterization)

Gaithersburg MD

Education: * For the Principal Scientist level we require a PhD in Chemistry, Biochemistry, Biophysics, Pharmaceutics, Chemical Engineering, Physics, or related field with at least 11 - 13 years of direct experience in the biopharmaceutical industry. * For the Senior Scientist level we require a PhD in Chemistry, Biochemistry Biophysics, Pharmaceutics, Chemical Engineering, Physics, or related field with at least 7 - 10 years of direct experience in the biopharmaceutical industry. Position: * This individual must be able to effectively work in a matrix environment and drive consensus on 'best answer' for complex scientific and business initiatives. * The individual is expected to work in the lab approximately 60% of their time and provide appreciable direction to younger scientists within Drug Product Analytics and Characterization Group including those who report directly or indirectly to him/her. * Has strong hands-on experience and state of the art knowledge of analytical and biophysical characterization of proteins by separation sciences (chromatograph and electrophoresis), and spectroscopic techniques (fluorescence, CD, Ramand stopped-flow, FTIR, NMR and dynamic and static light scattering), and other techniques including differential scanning calorimetry, ellipsometry, attenuated total reflection, and quartz microbalance. * Demonstrate extensive working experience in solving device and delivery-related protein stability challenges through sound and practical understanding of protein chemistry. * Has strong technical competence and credibility in the field of drug delivery for various routes of administration and is able to give assured technical direction. * Experience in sustained release of therapeutic proteins using polymers, polymer conjugates, or encapsulation desired. * Previous experience identifying and prioritizing technologies, requiring working knowledge of drug delivery technology uses, limitations, etc. and the ability to apply these technologies to biopharmaceuticals and vaccines is preferred. * Must possess clear project management capabilities in order to ensure that the cross-functional technology assessments and other processes are delivered on-time and of high quality. * Good communication skills, project management skills, strong interpersonal skills are essential. * Must possess demonstrated leadership capabilities, organization, flexibility and the ability to operate in a fast paced environment. * Problem solving and innovation as evident by strong publication record and patents are required skills for this role. *LI-MEDI

Posted On - 7/25/2014 7:21:35 AM

Manufacturing Technician II

Philadelphia (Non Sales) PA

Position: 0-2 years of experience with Bachelor's degree 2-4 years of experience with Associates degree 5+ years experience with High School Diploma Education: High School Diploma or general education degree (GED). Bachelor's Degree preferred.

Posted On - 7/23/2014 7:30:40 AM

R&D Associate I/II

Gaithersburg MD

* Good documentation, writing and communication skills, and GXP assay experience are required. * Experience working in a Biopharmaceutical company is preferred * Knowledge and hands on experience with Chromatographic Assay techniques such as: Protein A Affinity, HPSEC, IEC, and/or RPHPLC. desired * Experience with Karl Fischer Titration, pH and/or Spectrophotometric assays (A280) is highly desired. * Large molecule experience is preferred * Good time management and outstanding multi-tasking abilities * Team player Education: Education/Experience: BS (Science Major): 0-5 years, MS (Science Major): 0-2 years.

Posted On - 7/23/2014 7:30:40 AM

Scientist I/II

Gaithersburg MD

Position: Experience: a minimum of three years of post-degree research experience in antibody discovery. The ideal candidate must have an established record of innovative research in relevant fields. Must be independent, creative, and self-motivated. Must have hands on in-depth experience in hybridoma technology and good understanding in basic immunology, molecular biology, antibody discovery and antibody/protein engineering. Industry experience in a matrix environment is strongly preferred and experience with automation and high throughput screening is a plus. Education: Ph.D. in biological sciences or related discipline *LI-MEDI

Posted On - 7/23/2014 7:30:40 AM

Senior Manager, R&D

Gaithersburg MD

Required Education and Experience: * MS degree in Chemistry, Biochemistry or a related field with 14+ years of industry experience. * Ph.D. degree with 9+ years of industry experience. * Expertise in the integrated analytical and /or bioanalytical chemistry area, knowledge and working knowledge of HPLC /or UPLC, electrophoresis and mass spectrometry etc. with a deep understanding of applying analytical technology to elucidate protein structure and related quantitative and qualitative characteristics. * Excellent teamwork and communication skills, including good documentation and writing skills, are critical. * Good multi-tasking, time management and organizational skills are essential. * Strong verbal and written communication skills are essential. * Must possess Therno instrument or Waters' instrument operation and maintenance experience. * Proficiency with Empower, MassLynx, or Xcalibur is required. * Previous GLP and/or cGMP experience is desirable. * Supervisory, time/project management, and regulatory filing experience are desirable.

Posted On - 7/23/2014 7:30:40 AM

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

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