Posted On -
5/24/2013 6:03:51 AM
Gaithersburg
MD
Position:
0-2 years of CADD experience in mechanical, electrical or construction environment. Biopharmaceutical or cGMP experience a plus.
Education:
Proficient in AutoCAD with a two year Associates Degree in CADD, Engineering or Construction related programs.
Posted On -
5/23/2013 6:06:49 AM
Philadelphia (Non Sales)
PA
Position:
*Preparation of SOPs to support GMP production operations
* Prepare and maintain process equipment used in production support areas including but not limited to raw material
weigh and dispense areas. Prep tanks, parts washers and autoclaves.
* Provide support for general maintenance and order of all productions areas.
* General housekeeping of controlled areas
* Environmental Monitoring
* Other duties as assigned or identified
Education:
Bachelor Degree with 1-3 years of experience
Associate Degree 2-4 years experience
High School Diploma 5+ years experience
Posted On -
5/23/2013 6:06:49 AM
Gaithersburg
MD
Requirements:
*Experience in virology or immunology.
*Experience with molecular biology/molecular virology.
*Experience with RNA viruses
*Strong publication record
*Knowledge of various platforms to evaluate immunological responses to viral infection.
*Demonstrated ability to supervise and develop others, as well as, lead project teams.
*Demonstrated ability to effectively work in teams, both departmental and cross-functional.
Education:
*Ph.D. in virology, immunology, or other related field.
*1-5 years of relevant experience in the pharmaceutical or biotechnology industry.
Posted On -
5/23/2013 6:06:49 AM
Gaithersburg
MD
Position:
5-10 years of CAD experience in mechanical, electrical or construction environment. Demonstrated ability to create AutoCad drawings adhering to predetermined standards and modify existing drawings as needed.
Education:
Proficient in AutoCAD with a two year Associates Degree in an Engineering or Construction related program.
Posted On -
5/23/2013 6:06:49 AM
Gaithersburg
MD
Position:
Experience with MS Word/PowerPoint/Excel is essential. Desirable qualifications include prior laboratory experience; including weighing, pipetting, basic scientific calculations, handling of protein solutions and buffer preparation. Prior experience with preparation of scientific posters and presentations is desirable.
Education:
Candidate must be enrolled in a Bachelor's of Science or Master's of Science degree program in chemistry, biology, biochemistry, chemical engineering or other field related to biotechnology. Candidate must have completed a course in biochemistry.
Posted On -
5/22/2013 5:56:40 AM
Gaithersburg
MD
Education:
Requires a Bachelors/Masters degree in a scientific discipline or equivalent with a minimum of 4 years of experience with a Bachelors Degree or 2 years with a Masters Degree and demonstrated working knowledge of scientific principles.
Minimum of 2 years of experience.
Posted On -
5/22/2013 5:56:40 AM
Gaithersburg
MD
Position: Production Technician II 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
Production Technician III Assists more junior manufacturing personnel to comply with Standard Operating Procedures (SOP's), Master Production Records (MPR's), and Solution Production Records (SPRs) Serves as the "Subject Matter Expert" in unit operation Provides training to more junior staff, when needed Mentors others for the unit operation Routinely monitors manufacturing processes and recognizes potential process issues as they arise; proactively escalates identified issues to senior staff Troubleshoots problems and recommends potential solutions to those in more senior roles Contributes to the development of new concepts, techniques, and standards Reviews Master Production Records for accuracy and completion of process steps, as requested Leads unit operations or projects, as requested
Education: Production Technician II: Bachelors degree in the sciences preferred and 1-3 years relevant experience
Production Technician III: Bachelors degree in the sciences preferred and 3-5 years relevant experience
Posted On -
5/22/2013 5:56:40 AM
Frederick
MD
Position:
Candidate should have experience with large scale downstream processing equipment. Equipment to include but not limited to Ultrafiltration skids, chromatography columns and various column resins. Working knowledge of purification techniques is required. Some, but not all work experience should have been in a GMP facility. Experience with CIP/SIP is preferred. Aseptic experience is preferred. Experience with automated systems is preferred. Experience in a multi-product facility is beneficial. Knowledge of tech transfer is preferred.
Education:
1. BS/BA degree preferred with 3-5 years experience
2. Associates degree with 4-6 years experience, or High school education with 7-10 years experience
Posted On -
5/22/2013 5:56:40 AM
Gaithersburg
MD
We can hire at either the Project Lead, SAS Programming level or the Sr. Programmer, SAS Programming level.
For the Project Lead, SAS Programming level, we require a minimum of 8 years of clinical trial programming experience using SAS within pharmaceutical, biotechnology, and/or contract research organization industries. For the Sr. Programmer, SAS Programming level, we require a minimum of 5 years of clinical trial programming experience using SAS within pharmaceutical, biotechnology, and/or contract research organization industries.
Education:
Minimum of a BD Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field. Advanced degree preferred.
Posted On -
5/22/2013 5:56:40 AM
Gaithersburg
MD
Position:
* Serve as Operations representative on the PDT, working collaboratively and cross-functionally with other PDT members contributing to product vision, strategy, plans & delivery
* An empowered representative of Operations -- must consult with functional leaders and bring Operations view to the table to support PDT decision-making and planning
* Accountable to PDT and Operations Leadership for project-specific functional plan and deliverables.
* Develops long term commercial manufacturing strategies in conjunction with Operations representatives and Development CMC teams to ensure delivery of clinical and commercial product that is consistent with Operations long range strategy and PDT product commercialization strategies.
* Responsible to align Development and Operations technical decisions necessary through completion of Process Validation to ensure the commercial viability of the manufacturing process.
* Partner with Regulatory and CMC teams to support the technical content of filings and ensure flexibilities are built in to minimize impact of future process changes.
* Works with PDT team members to seek solutions for potential issues even if outside of functional area.
* Align on decisions once made; active communication and active support for PDT decisions, back to function, sub-team and other stakeholders
* May serve as Development Product Alignment Team (DPAT) lead and be accountable for proactive and ongoing communication of sub team activities to the PDT and Operations Leadership.
Education:
BS: Science or Engineering field required
MS/PhD: Chemical Engineering or Biological Sciences Field preferred
Posted On -
5/20/2013 6:10:21 AM
Gaithersburg
MD
Knowledge of a spectrum of purification principles and techniques. Lead process development and purification of new and difficult reagents.
Candidate is expected to design and perform protein purification experiments (such as chromatography and UF/DF); perform basic analytical testing of proteins (such as gel electrophoresis, HPLC and UV spectrometer); as well as analyze, document and report experimental data. Candidate will be generating materials under tight timelines and multiple requests, which require self-motivation, multi-tasking, flexibility and good communication skills. Ability to be an effective team player is essential. Critical thinking and attention to details required. Candidate will be working under minimum supervision but level of independence should increase with time.
Education:
B.S. /B.A. or M.S./M.A. in chemistry, biochemistry, chemical engineering
B.S/B.A with 1-5 years or M.S./M.A with 0-2 years relevant experience.
Posted On -
5/20/2013 6:10:21 AM
Gaithersburg
MD
We can hire this position at the Scientist I or the Associate Scientist II level. For Scientist I: Ph.D. in cell biology, microbiology, biochemistry, molecular biology or biochemical engineering or related disciplines plus 0-3 years industry experience, 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. For Associate Scientist II: B.S. degree in one of the above areas plus 8-10 years industry experience or M.S. degree in one of the above areas plus 5-8 years industry experience.
Extensive experience in cell and molecular biology, including mammalian cell culture and stable cell line generation. Experience with robotics, high-throughput processes and automated data management. Creativity, independence, high level of scientific curiosity. Interest in improving cell line development techniques. Excellent problem-solving and organization skills. Strong focus on details and results. Ability to learn rapidly and adapt to new challenges. Experience with microscopy, flow cytometry. Excellent sterile technique. High level computing skills required, including programming, word processing, spreadsheets and databases. Quantitative, technical writing and oral presentations skills essential. Ability to maintain careful and timely documentation of all activities. Periodic weekend work required.
Posted On -
5/20/2013 6:10:21 AM
Gaithersburg
MD
Position: * Serves as the expert in Clinical Data Management to provide support and advice to the clinical project team regarding the DM activities and deliverables to ensure effective delivery of the DM Center service. * Project related DM activities, technology and standards: o Ensure quality and consistency of DM components across therapeutic areas/programs. o Provide DM input to the development of clinical project standards and processes, including new concepts and techniques. o Ensure DM deliverables align with standards. o Provide DM and data collection expertise to study teams and development therapeutic area standards. o Provide DM business expertise and consultancy in the selection and use of software systems as appropriate. o Review project DM documentation and specifications as needed to ensure consistency with MedImmune strategies and standards. * Review, assess and manage DM Center delivery against KPIs and overall DM Center performance for studies. * Work with the DM Center, input to the production of the DM Service Order and study costs for studies being processed at the DM Center. * Ensure DM Center billing is accurate and manage invoicing process. * Initiate contract process for the database vendor and provide study team with estimated costs for hosting services. * Ensure study teams utilize standards by: o Working with study teams to understand and explain standards and escalates change requests to standards to the Standards Committee * Lead, coordinate and ensure transparency and consistency of MedImmune clinical study team and DM center activities including: o Provide the DM Center with MedImmune project planning information (scheduling of the studies, volumes, timelines etc.) o Facilitate DM related requests and issue escalation/resolution between MedImmune clinical study teams and the DM Center to meet study timeline and quality expectation o Monitor, manage and resolve escalated issues related to delays to DM Center deliverables by developing solutions to complex problems to ensure consistency across organization o Provide input to the DM related activities associated with regulatory inspections/audits * Assess MedImmune DM needs and improvement potential and recommend changes to the operating model * May be asked to provide strategic DM expertise to global Clinical Initiatives * May be asked to take on a global standards role as a member of the Standards Committee Education: * Education: University degree or equivalent experience * Minimum 6-8 years experience of working in Data Management in the Biotech/Pharma/CRO industry. * Demonstrated comprehensive knowledge and experience of most aspects of Data Management * Strong project management skills, communication skills, and interpersonal skills * Demonstrated leadership skills * Comprehensive knowledge of clinical and pharmaceutical drug development process and associated GCP * Comprehensive knowledge or regulatory requirements as they relate to DM activities * Comprehensive knowledge of data standards, database structures and of capturing and storing clinical information * EDC experience strongly preferred
* Education: University degree or equivalent experience * Minimum 6-8 years experience of working in Data Management in the Biotech/Pharma/CRO industry. * Demonstrated comprehensive knowledge and experience of most aspects of Data Management * Strong project management skills, communication skills, and interpersonal skills * Demonstrated leadership skills * Comprehensive knowledge of clinical and pharmaceutical drug development process and associated GCP * Comprehensive knowledge or regulatory requirements as they relate to DM activities * Comprehensive knowledge of data standards, database structures and of capturing and storing clinical information * EDC experience strongly preferred
Posted On -
5/17/2013 7:17:25 AM
Gaithersburg
MD
Position:
Position Requirements:
* Prefer a combination of at least 3 years experience in Sales Operations supporting efforts in territory alignments, call reporting, CRM and overall analytics.
* Exceptional understanding of Microsoft Office products (Word, Excel, Outlook, Project, PowerPoint and Access) and Adobe Acrobat.
* Strong knowledge of relevant healthcare industry data/information resources.
* Strong organizational and time management skills; ability to manage diverse range of simultaneous projects.
* Strong interpersonal skills, demonstrated ability to work collaboratively with peers and customers.
* Strong proactive communication (oral/written) skills and ability to present analytics to management team.
Successful performance in this position requires an individual who is proactive, analytical, inquisitive, and can manage projects/vendors while thriving in a fast paced, team-oriented environment. The analyst should have strong verbal and written communication skills, require little supervision, and should have a solid understanding of available data sources in the bio-pharmaceutical industry. Finally, this person should know how to form relationships and ultimately have the interpersonal skills necessary to influence others without authority.
Education:
* Bachelor's Degree required
* Related experience working in Sales Operations
* Preferred Background:
o MBA or Master's degree preferred in Business Administration, Statistics, Science or other healthcare relevant disciplines
Posted On -
5/17/2013 7:17:25 AM
Gaithersburg
MD
Please note that this position may be filled at either the Senior Project Manager level or the Project Manager level. This position may be located in either our Gaithersburg, MD office or our Cambridge, UK office.
For the Senior Project manager level, we require a minimum of 8 years of Project Management experience in a BioPharma Product Development environment. For the Project Manager level, we require a minimum of 5 years of Project Management experience in a BioPharma Product Development environment.
Required Skills:
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/BS in a biological science or equivalent work experience is required. An advanced degree (e.g., MBA, MS) is preferred.
Posted On -
5/17/2013 7:17:25 AM
Philadelphia North
PA
Position:
Judgment Requirements:
This position requires substantial individual judgment given the frequency and significance of interactions with MedImmune customers, and the seriousness associated with indications for MedImmune products. The BSS is expected to have the degree of judgment and diplomacy necessary to maintain cross-functional support. The BSS must know and always adhere to MedImmune policies and commit to doing business the right way.
Decision-making Requirements:
In this position, BSSs are expected to make broad day-to-day decisions and must, therefore, be able to make decisions that reflect and support the overall strategies of the area, region, and company. BSSs are expected to have the capacity to quickly and effectively respond to questions and unusual situations. Quality decisions, which may be made in the presence of customers, need to be based on appropriate training and personal judgment. Other key decision activities may include, but are not limited to, establishing hospital account and BSS territory objectives and tactics, prioritizing and selling to targeted customers, managing the BSS territory budget, and coordinating appropriate MedImmune and corporate partner personnel to accomplish objectives.
Initiative Requirements:
BSSs are expected to function effectively without close supervision. Therefore, it is imperative that each BSS possess a strong initiative, work ethic and be goal-oriented. BSSs should have a high degree of self-discipline and personal drive in order to focus on activities and communications that will support achievement of stated area, region, and company goals while continuing to build individual capabilities. BSSs must be self-motivated to seek out, recognize, and act upon local market opportunities central to the short-term and long-term success of the area, region, and company.
Outside:
Professional and diplomatic interaction with many levels of health and business professionals will be required.
Experience:
* A minimum of 2-3 years proven, successful sales experience in the Pharmaceutical, Biotechnology or Medical Products industry.
* Work experience in a medical setting (i.e. NICU, PICU or private physician office pediatric nursing, medical technology, respiratory therapy, physician's assistant, etc.) is beneficial but not required.
Supervision of Others:
None.
Travel Requirements:
Travel will vary by business territory. Overnight, multi-night, and/or weekend travel may be required to accomplish desired objectives. The BSS will be expected to be able to attend company meetings and use the company-mandated forms of transportation to and from those meetings.
Education:
Education and Special Skills:
* A four-year college degree, preferably in a scientific / medical or business discipline or relevant experience is required.
* Background in Managed Care, Marketing or Sales is beneficial.
Posted On -
5/17/2013 7:17:24 AM
Gaithersburg
MD
Minimum Requirement-Education and Experience
* Education: University degree in science related field; medical credentials preferred or equivalent experience.
* Minimum of 5 years coding using MedDRA and WHO Drug Dictionary and/or Clinical Data Management experience in the Biotech/Pharma/CRO industry.
* Demonstrated comprehensive knowledge and experience of most aspects of Data Management
* Comprehensive knowledge of clinical and pharmaceutical drug development process and associated GCP.
* Comprehensive knowledge or regulatory requirements as they relate to Data Management and Clinical Coding activities.
* EDC experience strongly preferred.
Posted On -
5/17/2013 7:17:24 AM
Gaithersburg
MD
This requisition can be filled at either the Senior Director or the Director level. For both levels, a proven track record of industry experience in Translational and Clinical Research in drug development. For the Senior Director level we require a minimum of 13 or more years of experience including industry experience in research and development of novel therapeutics for the treatment of respiratory, inflammation and autoimmunity, or clinical immunology disease. For the Director level, we require a minimum of 10 or more years of experience including industry experience in research and development of novel therapeutics for the treatment of respiratory, inflammation and autoimmunity, or clinical immunology disease.
Special Skills/Abilities:
? Firm understanding of the mechanistic basis of human diseases in the RIA space to drive target evaluation, biomarker selection and PHC strategies
? In depth knowledge of research and clinical development of biologic therapeutics.
? Familiarity with predictive biomarkers and personalized healthcare approaches as they pertain to research and early clinical development is highly desired.
? Hands-on experience in development of in vitro and in vivo assays for clinical and research use, with the aim of assessing biomarkers for indication selection.
? Understanding and ability to develop biomarker strategies and diagnostics to evaluate successful response to treatment with monoclonal antibody.
? Familiarity with clinical protocols and regulatory processes.
? Organizational skills with attention to detail and demonstrated ability to write technical reports, biomarker protocols, perform quantitative analyses, and graph and present data.
? Outstanding verbal and written communication skills.
? Strong leadership and interpersonal skills to work and lead in a matrix team environment.
? Problem solving and organizational skills
Education:
M.D., Ph.D., M.D./Ph.D. or equivalent with at least 10 - 15 years of experience including industry experience in research and development of novel therapeutics for the treatment of respiratory, inflammation and autoimmunity, or clinical immunology disease.
Posted On -
5/16/2013 6:29:16 AM
Gaithersburg
MD
Position:
* 15 + years of bio-pharmaceutical industry experience
* 5 + years in bio-pharmaceutical Operations involving complex project delivery
* Successful professional record of collaboratively delivering complex projects
* Outstanding communicator with excellent executive level presentation skills
* Working knowledge of the units of operations of a pharmaceutical supply chain
* Understanding of CMC, bio-pharm development, and Regulatory processes
* Knowledge and understanding of supply chain design and planning concepts
* Experience in financial budgeting (CapEx, OpEx, COGM)
Education:
* Required: Bachelors degree. Sciences or Engineering preferred.
* Advanced degree: MBA or Sciences preferred.
Posted On -
5/16/2013 6:29:16 AM
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