Gaithersburg
MD
Position:
3-4 years of biopharmaceutical industry experience, including 2+ years of writing experience. Experience with electronic submission systems, editing and reviewing large documents is required. Post-doctoral experience, as well as 1-2 years of direct supervisory experience in similar position is preferred. Experience preparing CMC regulatory documents and manuscripts is desirable.
Education:
Ph.D., or equivalent, in a scientific discipline relevant to manufacturing and drug development, such as cell culture, purification, analytical biochemistry, formulation, etc. Masters degree in a scientific discipline is acceptable with 4-5 years of laboratory and/or regulatory writing work experience. BA or BSc with 6-8 years of experience is also acceptable
Posted On -
6/17/2013 6:24:40 AM
Gaithersburg
MD
Position:
Typical Experience:
4 -- 6 years related
Certificates, Licenses, Registrations:
May include some or all of the following - Appropriate plumbing, HVAC, electrical, and mechanical Licenses (Maryland - EPA Refrigerant Recovery Type I, II, III or Universal Certification or Stationary Engineer Level II or III as required) and/or equivalent work experience to insure working knowledge
Education:
Typical Education:
Certificate of Completion at a 2 year technical trade school or,
High School diploma with experience in maintenance trades working in Pharma, Biotech or other highly regulated industry, Journeyman
Posted On -
6/14/2013 6:15:07 AM
Frederick
MD
Position:
* Knowledge of the job.
* Substantial acquaintance with and understanding of general aspects of the job with a broad understanding of the detailed aspects of the job
* Basic knowledge of cGMP principles and standards
Education:
* BS/BA degree preferred Associates degree and High School Diploma acceptable with experience
Posted On -
6/14/2013 6:15:07 AM
Gaithersburg
MD
Position:
Responsibilities and experience may include the following: Data entry of analytical data. Sampling of WFI and purified water systems, clean steam and compressed gases. Environmental Monitoring. Testing of water and product samples including conductivity, bioburden, endotoxin, TOC and microbial ID's, growth promotion, nano filtration, A280, water analysis. Maintain lab instrumentation. Read, understand and follow SOP's and comply with GMP's. Revise SOP's as needed. Data trending and archiving. Review of testing and documentation where required. Participate in QC project teams to accomplish effective results. Ability to take strategic initiatives and translate into tactical solutions.
Education:
B.S. in a Scientific Field preferably Microbiology. Candidates must have taken at least one university-level course in microbiology, including one lab.
Required Skills:
* Accurate data entry
* Experience with pipetting and aseptic technique
Posted On -
6/14/2013 6:15:07 AM
Philadelphia (Non Sales)
PA
Requirements:
*Knowledge of FDA cGMP
* Strong communication and leadership skills
* Strong problem solving skills
* Proven leadership to lead operational teams
* Ability to work shift and overtime as required
* Ability to lead and participate in cross functional teams
* Competent with MS applications
Minimum 2 years of experience in cGMP environment. Experience working in a Lean Manufacturing environment.
Preferred: SAP, Trackwise, and Aegis experience
Familiarity with the Optima Inova a plus
Education:
Bachelor degree with at least 2 years of experience in a cGMP environment
Associate degree with at least 5 years of experience in a cGMP environment
High School Diploma with at least 10 years of experience in a cGMP environment
Posted On -
6/14/2013 6:15:07 AM
Gaithersburg
MD
For the Research Associate II level, we require a BS degree with 2 - 5 years of relevant experience or an MS with 0 - 2 years of relevant experience. For the Associate Scientist I level, we require a BS with 5 - 8 years of relevant experience or an MS with 2 - 5 years of relevant experience.
Candidate must be able to perform laboratory work with minimal supervision and apply chemistry, biochemistry and pharmaceutical knowledge and principles to laboratory experiments. Candidate must have strong interpersonal, communication and presentation skills and the ability to thrive in a fast paced dynamic environment.
Education:
MS or BS in Chemistry, Biochemistry, Pharmaceutical Sciences, Bioengineering or a pharmaceutically related field.
Posted On -
6/13/2013 6:24:39 AM
Gaithersburg
MD
Education: Ph.D. in Chemistry, Biochemistry, or equivalent required.
Experience: Must have 7-10 years (Sr. Scientist) or 11-13 years (Principal Scientist) of experience in a biopharmaceutical company with relevant experience in vaccine development which includes structure-stability assessments using a variety of methods (e.g., ELISA, immuno-assays, spectroscopic, chromatographic, mass spectrometric, etc.). Lead method development, optimization, troubleshooting & tech transfer activities. Experience managing multiple direct reports is required.
Posted On -
6/13/2013 6:24:39 AM
Bensalem
PA
Position:
Required Education/Qualifications/Experience
* 5-10 years of work experience in pilot or commercial biologics manufacture under cGMP.
* Minimum of 3 years previous work experience in a cGMP warehouse
* Minimum 3 years prior supervisory or management experience
* Must have the ability to work overtime as required.
* Strong Warehouse Management System experience using SAP or other ERP systems
* Competent with Microsoft Office applications, especially Excel. Visio helpful.
* Capable of training full time and temporary FTEs
* Capable of independently managing a remote warehouse facility
Preferred Experience
* 7 years supervision of non-exempt level employees
* Green Belt certification or an equivalent Lean Enterprise certification
* DOT and IATA certification (HAZMAT shipping preparation)
* Certified Forklift trainer
* Hazardous waste management experience (spill containment)
* Cold chain management experience
Education:
Minimum BS/BA degree required
Posted On -
6/13/2013 6:24:38 AM
Gaithersburg
MD
Position:
BS degree with 0-3 year's relevant experience. Experience in developing and characterizing electrophoretic methods is needed.
Education:
BS in Protein Chemistry, Biochemistry or related discipline.
Posted On -
6/12/2013 6:14:52 AM
Gaithersburg
MD
Position:
Key Roles/ Responsibilities:
* Manage day to day activities of external vendors and deliverables
* Coordinate all appropriate aspects of patient case management through to completion, using effective interpersonal skills to manage interactions with vendors and MedImmune staff such as Field Reimbursement Managers and Managed Markets as necessary
* Serve as a single point of contact for Health Care Provider, patient and MedImmune partners and use regional reimbursement, distribution and payer policy expertise to provide solutions for complex patient access situations, working closely with Field Reimbursement Managers and the Managed Markets Trade team to appropriately escalate/resolve issues
* Educate offices on Access 360 programs and referral process to ensure timely case processing
* Work collaboratively with Managed Markets partner teams to develop strategic solutions to payer policies that impact patient access
* Provide sound analytics and solutions around general reimbursement trends and challenges such as health care reform
* Prepare and present presentations to Sr. Leadership summarizing service utilization, gaps, improvements and opportunities
Minimum Requirements:
* Bachelor's degree, RN or equivalent education or greater (health sciences, managed healthcare, public policy, social worker or related disciplines are preferred)
* Minimum 3 years of healthcare/healthcare reimbursement experience; high level of proficiency in all aspects of reimbursement and access, i.e., benefit investigations, specialty pharmacy distribution, private and public payer reimbursement policies and procedures, regulatory and administrative rules, etc. is required
* Coordination of patient access experience
* Expert knowledge of specialty products, reimbursement for medical and pharmacy benefits, patient access processes 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
* Experience with HIPPA policy, patient access data and analytics
* 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
Expected Competencies:
* Ability to drive projects and cases to completion, be self-directed, have excellent verbal and written communication skills
* Analytical thinking, problem solving and decision making
* Effective organizational management
* Provide organization systems for designing and measuring work processes
* Dedication to continuous improvement through empowerment and management by data and market research
* Proficient competency using Word, Excel and PowerPoint
* Ability to multitask and manage multiple parallel projects
* Business acumen; knowledgeable in current and possible future policies, practices, trends, technology and information affecting Access Services programs
* Work hours may vary depending on regional alignment to Field Reimbursement Managers
Education:
Education:
* Bachelor's degree, RN or equivalent education or greater (health sciences, managed healthcare, public policy, social worker or related disciplines are preferred)
* Minimum 3 years of healthcare/healthcare reimbursement experience; high level of proficiency in all aspects of reimbursement and access, i.e., benefit investigations, specialty pharmacy distribution, private and public payer reimbursement policies and procedures, regulatory and administrative rules, etc. is required
Posted On -
6/11/2013 6:18:31 AM
Gaithersburg
MD
Experience: Ph.D. degree with 3-8 year's relevant experience. Expertise in developing methods for analysis of monoclonal antibodies and other protein molecules using appropriate immunoassays. Some experience with DNA/PCR techniques is preferred.
Education:
Education: Ph.D. in Immunology, Protein Chemistry or related discipline.
Posted On -
6/10/2013 6:13:05 AM
Minneapolis
MN
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 -
6/10/2013 6:13:04 AM
Gaithersburg
MD
Position:
Requirements/Qualifications:
Experience: A minimum of 3-4 years must be in the biopharmaceutical industry, with 2 years experience in pharmacovigilance. Prior experience in clinical safety including all phases of clinical development and registration experience (BLA, NDA, or MAA) is highly desirable. Demonstrated ability to provide meaningful input to protocol development and interpret clinical data from a safety perspective is highly desirable. Specific experience in clinical epidemiology, drug or vaccine development, public health epidemiology or hospital epidemiology is a plus. The candidate should have demonstrated ability to understand epidemiological data and perform risk assessment analysis of adverse events. As this position includes communication of safety information and analysis within the medical organization in addition to regulatory authorities and the medical community, good communication skills (verbal and written) are required.
Education:
Requirements/Qualifications:
Education: Doctor of Medicine with board certification or board eligibility. Infectious disease, oncology, or pulmonology therapeutic areas preferred but other specialties may be considered. Current U.S. license (in one or more states) preferred.
Posted On -
6/10/2013 6:13:04 AM
Frederick
MD
Position:
3-5 years of experience in Quality Assurance.
Prefer experience in Biotech environment.
Education:
Bachelors of Science
Posted On -
6/10/2013 6:13:04 AM
Philadelphia (Non Sales)
PA
Required
Minimum of 7 years related cGMP operations experience
Experience in managing capital projects
Preferred
Project Management Professional (PMP) certification, Process Excellence and/or Six Sigma certification
Fill/ pack operations experience
Aseptic production experience
Education:
Minimum - Bachelor's degree (B.S.) in science or engineering
Posted On -
6/7/2013 6:25:51 AM
Mountain View
CA
Position:
* Must have the ability to adapt, work through conflicts, and persuasively influence outcomes
* Must have demonstrated the ability to work effectively in a remote location; self-directed and able to work independently
* Can effectively cope with change and is comfortable changing direction and acting without complete information
* Establishes and maintains effective relationships with business clients and gains their respect and trust
* Ability to develop and deliver effective reports, presentations, and written/oral communications
* Strong organizational and prioritization skills
* Team player, works with others effectively, respectfully, and cordially
Education:
* Education: BS/BA in Human Resources or related field required. Masters degree a plus.
* Experience: Five years' experience as an HR Generalist with a strong background in core HR functions
* Experience in biotech or pharma a plus
Posted On -
6/7/2013 6:25:51 AM
Gaithersburg
MD
Position:
Intermediate experience of working for a (bio)pharmaceutical company/CRO, particularly within Pharmacovigilance in conduct and support of case handling activities for clinical trial and post-marketed products with some knowledge and experience of activities such as case processing compliance tracking and literature monitoring an advantage (as a guide, will have a minimum of 3 years experience)
Intermediate working knowledge of U.S. and international regulations in relation to post-marketing and clinical trial requirements and understanding of aggregate report requirements
Intermediate experience with safety databases including ability to perform non-complex searches; familiarity with medical terminology or MedDRA
Education:
Health Care Professional (HCP) or Bachelors Degree in scientific related field
Posted On -
6/7/2013 6:25:51 AM
Fort Wayne
IN
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 -
6/6/2013 7:30:12 AM
Gaithersburg
MD
Position:
Typical Experience:
4 -- 6 years related
Certificates, Licenses, Registrations:
May include some or all of the following - Appropriate plumbing, HVAC, electrical, and mechanical Licenses (Maryland - EPA Refrigerant Recovery Type I, II, III or Universal Certification or Stationary Engineer Level I, II or III as required) and/or equivalent work experience to insure working knowledge
Education:
Typical Education:
Certificate of Completion at a 2 year technical trade school or,
High School diploma with experience in maintenance trades working in Pharma, Biotech or other highly regulated industry, Journeyman
Posted On -
6/6/2013 7:30:12 AM
Frederick
MD
Position:
o Thorough understanding of laboratory operations demonstrated through direct experience working in the lab or through experience supporting laboratory systems in a Systems Administrator or a LIMS Administrator role.
o Follows established procedures to perform job requirements
o Good understanding of current Good Manufacturing Practices (cGMP) and FDA guidelines for 21 CFR Part 11 for electronic records compliance.
o Collaborates with other departments such IS and QA to provide technology solutions that meet business needs.
Education:
Bachelors degree in Computer Science/Information Systems or in a scientific/Biotech field of study.
Posted On -
6/6/2013 7:30:12 AM
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