Responsibilities:
Analytical testing of raw materials, bulk formulations and final product.
Follow SOPs for routine assays (SDS-PAGE, Western Blot, Chromatography, ELISA, Protein assay, etc.)
Assists in the writing, reviewing and editing of reports.
The Feasibility Manager is responsible for managing feasibility projects through completion in accordance to the Feasibility Group operational procedures in:
' Acting as the contact between the Business Development Department and the Clinical Operations, Business Administration and Medical Affairs Departments.
' Retrieving PAREXEL internal information from corporate databases and from collaboration with other departments including medical, clinical operations, volunteer recruitment and project management.
' Presenting feasibility results, including findings, rationale and costing, and supporting development of feasibility strategy in terms of country and unit choice.
' Completing a text proposal (including costing) and providing the Business Development department with a complete Proposal Document.
' The Feasibility Manager is furthermore expected to ensure that the local information database is kept up to date.
' The Feasibility Manager will continue to strive to minimize the response times and increase the win-rate of projects by delivering any information in a professional format.
' Support the Manager of Feasibility and drive strategies to fully leverage the PAREXEL Early Phase network capabilities and offerings in to help achieve the NBA targets by delivering highly professional information in the shortest possible time to the Business Development office and increasing the competitive win rate of the Early Phase network.
' Lead and participate in Global Feasibility Projects & initiatives
' Closely cooperate with the Global Business Development teams to provide our clients comprehensive and competitive feasibility & proposal and costing packages
Key Accountabilities
' Organization of the feasibility process, analysis thereof and compilation of the respective documents
' Compilation of documents and packages
' External and Internal Consulting with other departments including business development department, medical and clinical operations, volunteer recruitment group, project management, laboratory services and pharmacy
' Providing Business Development with any past history/ experience of PAREXEL Early Phase.
' Maintaining the 'Global PAREXEL Feasibility Data Bank' ' structured according to various categories of importance for example: indication areas, methods, equipment, recruitment comments etc, )
' Support Business Development on feasibility and the proposal during client teleconferences or meetings.
' Perform feasibility requests and provide text proposals both locally and globally in the Early Phase units
' Acquire and maintain good knowledge of all corporate systems required for the feasibility activity. Be able to extract/retrieve relevant information about previous PAREXEL's studies.
' Analyze study outline and identify possible medical, logistic, costing and/or regulatory issues prior to development of protocol-specific questionnaire.
' Review and analyze all information retrieved from internal and external investigation, as appropriate, and compile summary and conclusions into feasibility report, text, and/or slides within appropriate timelines.
' Develop and prepare regular and ad hoc analysis and reports
' Ensure that all Requests for Proposals (RFP's) and Request for Information (RFI's) are responded to in a timely and comprehensive manner and reflect the requirements of the Sponsor
' Work with Business Development to provide a comprehensive and smooth handover to operational staff once a project is won.
' Assume other duties and responsibilities as assigned. The above responsibilities are a general description of the level and natures of the work assigned and are not intended to be all-inclusive.
Skills
' Sense of urgency, initiative, and diplomacy;
' Strong analysis and synthesis skills;
' Working knowledge of worldwide clinical research
' Excellent interpersonal, verbal and written communication skills;
' A flexible attitude with respect to work assignments and new learning;
' Ability to manage multiple and varied tasks with enthusiasm and prioritize workload;
' Willingness to work in a matrix environment and to value the importance of teamwork.
' High level computer skills including Word, Excel, PowerPoint and Internet;
' Well-developed problem-solving and analytical skills
' International business experience preferred.
Education
' BA/BS in Business or Healthcare related or Science subject
Language Skills
' Fluent oral and writing English mandatory
Responsible for designing, developing, and sustaining optical, and opto-electromechanical systems for diagnostic medical microbiology and molecular instrumentation. Works closely with Electrical, Mechanical, Systems and Software Engineering associates as a member of a project team. Independently evaluates and applies engineering principles to fulfill project objectives. Collects, analyzes, interprets, and reports on data. Presents results to others. Design, develop, and execute optical subsystems with minimal supervision. Acts independently, provides guidance and work assignments to less experienced technicians and engineers.
DUTIES AND RESPONSIBILITIES :
· Develop design input (specifications) for optical systems in instrumented products.
· Lead or be in sole responsibility for the detail design of optical subsystems.
· Apply engineering principles, analytical skills, and empirical methods to develop statistically robust designs.
· Design products to meet cost targets. Prepare cost estimates of components and assembly labor.
· Accurately estimate work effort for specific engineering tasks for schedule allocation of optical engineering resources.
· Lead, contribute to, and participate in design reviews. Thoroughly assess the ability of proposed designs to meet specified requirements, including manufacturability.
· Assist in test planning and development to insure instrument systems and sub-systems conform to requirements on reliability and robustness.
· Complete assignments within established schedules and budgets.
· Interact closely with mechanical, electrical, systems, and software engineering functions to develop comprehensive solutions to design problems.
· Conform to the requirements of ISO 9001 and CGMP standards for the design and development of medical devices.
EXPERIENCE:
Optical design experience on fluorescence based detection systems. Hands-on experience effectively resolving design, manufacturing, and vendor issues associated with tightly specified parts, component variability and obsolescence. Optics knowledge and experience are required in the following areas:
¨ LED's: specifications, construction, test & burn-in methods
¨ Optical filters: characteristics, coatings, specifications, test & evaluation methods
¨ Thermal characteristics of optical detection devices.
¨ Spectral analysis, imaging optics, and alignment methods
¨ Integration effects of components
¨ Fiber optics: construction, specification, evaluation & test methods
¨ Knowledge and experience in both sequential and non-sequential ray tracing software.
¨ Knowledge of process and tolerance capability of lenses and optical components
¨ Knowledge of fluorescence standards and calibration
¨ Familiarity with digital, analog, electronic circuits design, particularly weak opto-electric signal detection, and troubleshooting is desirable.
Minimum of an M.S. in microbiology, molecular biology or bacteriology; with a cross-over background in the other fields.
Capable of culture-based work for the cultivation of microbial communities.
Working knowledge of DNA/RNA isolation techniques from a variety of matrices.
Experience in DNA/RNA manipulation with molecular-grade enzymes, labeling, and microarray hybridization.
Ability to employ techniques such as PCR (involving gene or whole genome amplification), RT-PCR, plasmid purification, DNA sequencing, gene cloning, and library construction/screening with antibody or oligo probes.
Some bioinformatic capabilities with phylogenetic interpretation would be desired.
A working knowledge of BLAST, as well as gene/genome browsing on GenBank.
Ability to utilize a variety of sequence analysis software programs.
The essential function of this position is to support the product line by taking responsibility to coordinate the marketing and technical aspects to include, phone support, product sales support, training, applications, repair, maintenance, installation and phone support of assigned products sold by Shimadzu Scientific Instruments.
Job Requirements:
Incumbent must be proficient at effectively troubleshooting operational, application and other instrument problems in a methodical efficient manner. Additionally, incumbent must be able to act independently in matters not governed by policy to ensure customer satisfaction. Incumbent must have a Bachelors degree in the physical or natural sciences with at least two years of technical applications experience in the appropriate product line (DP/computers) or the equivalent experience in maintenance and/or repair of analytical instrumentation.
Shimadzu Scientific Instruments Inc. is and EOE - M/F/D/V.
Key Accountabilities:
' Ensure that all Requests for Proposals are responded to in a timely and comprehensive manner and reflect the requirements of the RFP
' Prepare budget bid grids as required by the sponsor
' Ensure that feasibility concerns are captured in a concise and thorough manner in the proposal and are reflected in the study costs.
' Participate in conference calls or face-to-face meetings with clients to determine exact scope of work.
' Liaise with external groups such as CRS and 3rd party vendors to negotiate for additional services as required.
' Work with Manager BusOps and Director BD to prepare final documents for delivery to client by Director BD.
' As requested by the BD Director(s), participate in telephone conferences with clients to ascertain the scope of work or modifications being requested.
' Work with Business Development to provide a comprehensive and smooth handover to operational staff once a project is won.
' Billing and Invoicing of all contracted studies. T.I.M.E. maintenance for Baltimore Clinical Pharmacology Research Unit. Exemplifies Guest and Staff Relations standards in all activities. Maintain status of all financial and contractual information in Clinbase on an on-going basis, providing reports as required.
' As requested by senior staff, assist in the development, modification and testing of PD tools and systems.
' Work with the BD Director and other staff to plan strategies to expand and develop services and capabilities of the Unit.
' Provide summaries or lists of study information in order to respond to Requests for Information (RFIs) or provide information for inclusion in marketing materials or presentations. Assist with the preparation of presentations.
' Assume other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned and are not intended to b all-inclusive.
Skills:
' Excellent communication and interpersonal skills, well-developed problem-solving and analytical skills, excellent financial skills, ability to work on multiple projects simultaneously, ability to meet deadlines, computer literate with a high level of competence in the use of spreadsheets; experience with PowerPoint preferred; occasional travel as required.
Education:
' BA/BS in Healthcare related or Science subject, Minimum Work
Candidate will be responsible, but not limited to the following:
-Inventory of pharmacy area
-Documentation of activity
-Data entry
-Disbursement of medication
-Traveling to various locations within the greater Baltimore area
For this position only local candidates will be considered.
Please submit resume and reference information to Thomas Stover at tstover@aerotek.com.
All referrals are welcome.
About Aerotek:
Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.
DUTIES AND RESPONSIBILITIES:
Develop design input (specifications) for mechanical systems in instrumented products.
Lead or be in sole responsibility for the detail design of mechanical subsystems.
Apply engineering principles, analytical skills, and empirical methods to develop statistically robust designs.
Design products to meet cost targets. Prepare cost estimates of mechanical components and assembly labor.
Accurately estimate work effort for specific engineering tasks for schedule allocation of mechanical engineering manpower.
Lead, contribute to, and participate in design reviews. Thoroughly assess the ability of proposed designs to meet specified requirements, including manufacturability.
Assist in test planning and development to insure instrument systems and sub-systems conform to requirements on reliability and robustness.
Complete assignments within established schedules and budgets.
Interact closely with software, systems, and electrical engineering functions to develop comprehensive solutions to design problems.
Generate engineering documents, drawings and specifications to internal and industry standards, including ASME Y14.5M-1994 Dimensioning and Tolerancing.
Conform to the requirements of ISO 9001 and CGMP standards for the design and development of medical devices.
Job Responsibilities
Develops, reviews, and approves protocols for all TB/HIV studies.
Involved in identifying investigators and sites for the TB/HIV study, and the longer development plan.
Develops relationships with treating physicians and applies their input to enhance study design and protocols.
Assists the sites in building the capacity needed to conduct clinical trials, and provides the interface between clinical study needs and patient care.
Ensures successful patient enrollment and proof of concept.
Establishes the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of drug candidates.
Provides input and insight to internal and external groups on the science of TB and infectious disease.
Provides medical monitoring for the studies.
Provides global safety monitoring and works closely with project lead(s) for safety to actualize the protocol.
Knowledge, Skills, and Competencies
Substantial knowledge of and experience with HIV. Must be a recognized expert in HIV, with strong relationships with treating physicians.
Strong working knowledge of clinical development, clinical trial management, and applicable global regulatory requirements and compliance.
Working knowledge of associated disciplines including biostatistics, data management, and medical writing.
Skills
Ability to build and support effective working relationships with internal groups, global affiliates, and external groups (including physicians, CROs, CDC, FDA, academic groups, vendors).
Strong oral and written communication skills; strong presentation skills.
Demonstrated ability to manage people.
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
Knows how/when to apply organizational policy or procedures to a variety of situations.
Physical Demands and Work Environment:
50% travel.
Summary:
We are looking for a Research Associate to work on immunoassay product development. This position will be responsible for executing lab functions including experiments and testing as needed with a focus on assay development, troubleshooting and optimization, and product development.
Responsibilities:
The primary responsibility will be carrying out assay development activities in the lab under the supervision of a Scientist working to achieve development project goals. Tasks will include:
Organizing and procuring needed reagents, performing immunoassays, analyzing data, and documenting results.
Effective interaction with other groups will be required.
Presentation of results
Contribution to scientific efforts of the group
Participation in general lab maintenance including maintaining lab supplies and equipment.
Some projects will require running assays with Biosafety Level 2 samples such as human serum and plasma so prior training and experience with BSL2 techniques is desirable.
The position will be responsible for understanding and following laboratory safety precautions and proper use of personal protective equipment.
The successful candidate will gain exposure to a wide variety of products and have an opportunity to develop and contribute in an exciting area of growth.
Plan and execute scientific tasks within biomedical field of expertise. Provide guidance to research associates, laboratory technicians, and junior scientists in accomplishing project goals. Makes presentations and contributes to scientific documents.
Skills and Qualifications:
Minimum General Experience: Eight (8) years of related experience.
Education and Certifications:
Minimum Education: PhD, MD, DO or DVM degree.
Clearances:
Must be willing to submit necessary information to conduct a personnel background check.
Other:
Work location is Bethesda, Maryland area or in the Hamilton, Montana area; or in Washington DC Metro area.
Hours for the position will be the core hours of 8:15 am to 5:00 pm, Monday through Friday.
Plan and execute scientific tasks within biomedical field of expertise. Provides
guidance to research associates and laboratory technicians in accomplishing project goals. Makes presentations and contributes to scientific documents.
Skills and Qualifications:
Minimum General Experience: One (1) year of related experience.
Expertise in microscopy and biological imaging techniques. Familiarity with general light microscopy techniques (e.g. immunofluorescence, image capture) and image processing software; and experience with confocal microscopy.
Education and Certifications:
Minimum Education: PhD in the biosciences or physics
Clearances:
Must be willing to submit necessary information to conduct a personnel background check.
Other:
Work location is Bethesda, Maryland area or in the Hamilton, Montana area; or in Washington DC Metro area.
Hours for the position will be the core hours of 8:15 am to 5:00 pm, Monday through Friday.
The Clinical Project Lead (CPL) is responsible for leading the planning, negotiating, scheduling initiating and monitoring of clinical trials of moderate to high complexity in the women's health and /or sexually transmitted diseases field. The CPL leads internal and external CRAs to ensure compliance with device and PMA regulations and smooth conduct of clinical trials. The CPL is responsible for preparing reports of study results for investigators, assisting in preparation of regulatory submissions, and supporting publication activities. The CPL will interface with appropriate internal individuals to manage trials in order to meet business objectives and timelines, provide clinical and technical support to product development activities, support product launches, and/or conduct post-market surveillance and evaluation activities.
The position reports to the Medical Manager, Medical Affairs. The CPL is responsible for leading the execution of complex clinical projects and must work both independently and in a team environment.
Functional Responsibilities:
1. Responsible for leading planning, budgeting, executing, and monitoring clinical evaluations of products to support product development. Clinical evaluations may also be for post-market surveillance studies, or claims extensions of existing products.
2. Uses past clinical experience to support project planning and execution related to medical procedures performed during clinical trials related to women's health projects.
3. Activities will be performed in accordance with international, federal and/or local regulations (FDA, ISO), Good Clinical Practices (GCPs), and compliance with corporate and local quality policies and procedures.
Specific Responsibilities:
· Manages all activities related to multi-center trials.
· Coordinates activities with contract research organizations (CRO).
· Leads project-related activity of internal and external Clinical Research Associates.
· Screen, select, and qualify principal investigators and investigational sites.
· Conduct negotiations of clinical site budgets and contracts.
· Conducts "monitor training meetings".
· Coordinates monitoring visits and reviews monitoring reports.
· Mentor more junior clinical operations personnel.
· Ensure the compliance to all human subject protection and privacy regulations, including developing Informed Consent materials.
· Monitor clinical data and identify trends. Participate in data analysis planning.
· Develop medical project schedule and track tasks and provide back-up strategies to meet overall project schedule.
· Plan availability of supplies and shipment of materials.
· Coordinate training of clinical evaluation participants in study products and procedures.
· Monitor sites to assure that the Protocol is understood and followed.
· Communicate results of data analysis to each clinical center and actively support the publication and presentation of results by investigators.
· Support the reporting of performance data to regulatory authorities.
· Anticipate 25%-35% travel (primarily domestic; international travel a possibility).
Qualifications
Education and Experience
· BSN with clinical nursing
· Minimum 5 year in project management experience
· Five or more years experience in clinical trials in the medical device industry or in oncology device trials preferably in a CRO environment or with a device sponsor with PMA experience.
· Clinical Research Certification is preferred
Knowledge and Skills
· Deep knowledge of device regulations including PMA regulations. Working knowledge of Good Clinical Practices, human subject protection regulations, safety data monitoring,
· Must have excellent interpersonal, presentation, writing and communication skills.
· Must have strong knowledge of scientific study design and data analysis.
· Must have strong computer skills (MS Office, including Project, Word, Excel, Access, PowerPoint, ) -- prefer working knowledge of statistics and data analysis- preferred skills in database management.
· Ability and willingness to travel to domestic (and possibly) international locations as necessary (anticipate 25%-35% travel)
REQUIREMENTS:
-Data Entry
-General understanding of pharmaceutical naming and strong research skills
-Microsoft Office applications
-Email and scheduling software
-Web browsers and applications
Plans and oversees the integration and upgrades of company's application portfolio, including systems such as Documentum, Liquent Insight Publisher, ARISg, Clintrial, Integic, Impact, EDC, etc.
Designs, evaluates and modifies computer programs for the solution of business problems to support various areas of the organization
Troubleshoots system problems by gaining an understanding of the underlying technical architecture of commercial applications and working with vendor support groups.
Analyzes databases of purchased systems and develop business intelligence, ad hoc reports and customizations for various internal client groups
Determines system specifications for hardware / software compatibility
Configures commercial systems to meet business needs
Plans and execute acceptance testing
Research, design, evaluate and modify enterprise wide (internal to company) software
Write documentation (e.g., testing, validation, and maintenance) of new or existing programs
Work with cross-functional linked teams to address business or system issues
Execute all tasks in a controlled and regulated environment
Requirements:
Bachelors degree with 3-5 years technical experience or a Masters degree with 2+ years of experience
Extensive knowledge of one or more, operating systems and programming languages
Strong database reporting and SQL skills
Ability to work on complex problems with general direction
Work independently in implementing solutions
Strong preference for candidates who have experience working in the Biotech or Pharmaceutical industry
This position will pay a $1000.00 stipend. If interested in applying, please send resume to Shannon Gibson, HR Manager at sgibson@spsfg.org. St. Paul's School for Girls is an equal opportunity employer.
Responsibilities:
Analytical testing of raw materials, bulk formulations and final product.
Follow SOPs for routine assays (SDS-PAGE, Western Blot, Chromatography, ELISA, Protein assay, etc.)
Assists in the writing, reviewing and editing of reports.
Requirements:
Bachelors degree in chemistry, biology, pharmacy, engineering or equivalent with 3-4 years experience in pharmaceutical, biologics, biotech R&D environment pertaining to analytical development / quality control aspects.
Knowledge and expertise in principles and practice of GMP and GLP.
Experience in handling sterile dosage forms and aseptic preparation techniques.
This position requires hands-on execution of development, scale-up and optimization of cell culture production processes. Experience with bioreactors and scale-up is absolutely key for this position.
Responsibilities:
Develop high titer, scalable upstream cell culture processes for vaccine and biologic products.
Prepare and characterize cell banks and virus seed stocks, formulate and improve media, develop fed-batch cell culture, scale up and optimize processes.
Perform critical operations as needed in our development and cGMP manufacturing facility.
Assist in the maintenance of cGLP/cGMP requirements.
Prepares all samples for analysis according to priority and testing set specified, using standard laboratory protocols; completes QC worksheet and updates database.
Processes full cases according to priority; completes QC worksheet.
Tests processed cases, including analysis and completion of all forms and entry of loading information into database.
Prepares stock reagents and working reagents as needed; notifies manager when supplies of chemicals and/or consumables are low.
Monitors the performance of all equipment before and during use; reports discrepancies to supervisor as soon as possible; documents on QC worksheet.
Maintains Daily Log to document workflow and reagent preparation.
Specimen receipt, handling, and storage (e.g. chain-of-custody)
Experience:
BS/BA in one of the chemical, physical or biological sciences and, in addition, at least one year of pertinent laboratory experience and/or training covering the specialty.
Experience running Clinical Assays is a must!
· Develop design input (specifications) for optical systems in instrumented products.
· Lead or be in sole responsibility for the detail design of optical subsystems.
· Apply engineering principles, analytical skills, and empirical methods to develop statistically robust designs.
· Design products to meet cost targets. Prepare cost estimates of components and assembly labor.
· Accurately estimate work effort for specific engineering tasks for schedule allocation of optical engineering resources.
· Lead, contribute to, and participate in design reviews. Thoroughly assess the ability of proposed designs to meet specified requirements, including manufacturability.
· Assist in test planning and development to insure instrument systems and sub-systems conform to requirements on reliability and robustness.
· Complete assignments within established schedules and budgets.
· Interact closely with mechanical, electrical, systems, and software engineering functions to develop comprehensive solutions to design problems.
· Conform to the requirements of ISO 9001 and CGMP standards for the design and development of medical devices.
EXPERIENCE:
Optical design experience on fluorescence based detection systems. Hands-on experience effectively resolving design, manufacturing, and vendor issues associated with tightly specified parts, component variability and obsolescence. Optics knowledge and experience are required in the following areas:
· LED's: specifications, construction, test & burn-in methods
· Optical filters: characteristics, coatings, specifications, test & evaluation methods
· Thermal characteristics of optical detection devices.
· Spectral analysis, imaging optics, and alignment methods
· Integration effects of components
· Fiber optics: construction, specification, evaluation & test methods
· Knowledge and experience in both sequential and non-sequential ray tracing software.
· Knowledge of process and tolerance capability of lenses and optical components
· Knowledge of fluorescence standards and calibration
· Familiarity with digital, analog, electronic circuits design, particularly weak opto-electric signal detection, and troubleshooting is desirable.
MINIMUM QUALIFICATIONS:
B.S. in optical engineering, mechanical engineering, electric engineering or physics with 5+ years related optical design experience. or M.S in optical engineering , mechanical engineering, electric engineering or physics with 3+ years related optical design experience.
· Responsible for management of product requirements and high-level design specifications
· Contributes to product conceptualization and develops work plans to reduce concept to design
· Assumes a technical contributor role and works closely with other functional groups, especially assay development and engineering
· Independently evaluates problems of moderate complexity and applies analytical/scientific principles to fulfill project and business objectives
· Collects, records, reports, interprets and analyzes data, presents results to others
· Acts independently within team expectations, provides guidance and work assignments to less experienced team members
· May train, develop or assign work to others; provides technical guidance to less experienced scientists and engineers.
· Responsible for implementation of DFSS and Technology Development practices
· Coordinates system verification and validation activities
· Contributes to the transition from R&D to manufacturing and to system troubleshooting activities for products in the field
MINIMUM QUALIFICATIONS:
KNOWLEDGE AND SKILLS:
Experience with in vitro diagnostic development.
Experience with data acquisition, analysis, and statistical methods.
Experience in one or more of the following areas: microbiology or molecular biology.
Familiarity with diagnostic instrumentation such as fluorometers, spectrophotometers, and incubation systems
Experience with requirement and specification management for FDA regulated products
Excellent written and oral communication and interpersonal skills are essential
Experience as member of project team and leader of a small project team
EDUCATION AND EXPERIENCE:
A B.S. or M.S in Engineering or Life Sciences
Minimum of seven years relevant experience
Location: Sparks, MD
Compensation: Based on applicable experience
Principals only. Recruiters, please don't contact this job poster.
Please, no phone calls about this job!
Please do not contact job poster about other services, products or commercial interests.
POSITION TITLE: R&D Electrical Project Electrical Engineer
DEPARTMENT: R&D Hardware Engineering
The statements below are intended to describe the general nature and level of work being performed by associates assigned to this job. This job description is not intended to be an exhaustive list of all responsibilities, duties, and skills required of associates so classified.
JOB SUMMARY:
Manages and participates in the design and development efforts of the electrical engineering team on multi-disciplinary projects to produce technically sound medical instrumentation. Participates in the project planning and ensures that schedule milestones are met. Responsible for the design and development of electrical and electronic designs required for instrumented micro and molecular biological systems. Works closely with other EE, ME, Systems and Software Engineering associates as a member of an instrument system project team. Independently evaluates and applies engineering principles to fulfill project objectives. Collects, records, reports, interprets and analyzes data, presents results to others. Design, develop, and execute electrical and embedded software subsystems with minimal supervision. Provides guidance and work assignments to engineers and technicians. May have direct management responsibilities for one or more associates.
DUTIES AND RESPONSIBILITIES:
Learn & practice the BD Global Product Development System phase gate design process. Conduct project work in compliance with BD internal processes, ISO 9001 and FDA cGMP standards for the design of medical devices.
Develop system level design input (specifications) for the electrical and electro-optical systems in instrumented products.
Apply electrical engineering expertise to develop instrument system architecture and resolve complex issues.
Manage and / or lead the design effort of major electrical/electro-optical subsystems.
Directly apply expert knowledge in electronics and electro-optics to execute overall project assignments.
Lead or participate in design reviews. Thoroughly assess the ability of proposed designs to meet specified requirements, including manufacturability and serviceability.
Interact closely with software, systems, mechanical, and electrical engineering functions to develop comprehensive solutions to design problems.
Interact with Manufacturing, Medical, Regulatory, Marketing, and Field Service throughout projects providing high level technical assessments and communications to applicable business leadership.
Plan and lead technical development activities from concept through successful commercialization within established schedules, budgets, and product cost targets.
MINIMUM QUALIFICATIONS:
KNOWLEDGE AND SKILLS:
Experienced in PCB layout, construction and test techniques.
Experience with interfacing optical hardware (LEDs, photodiodes, laser diodes, PMTs, etc.), motion (DC & stepper motor).
Temperature control experience; driving heaters, blowers, and TEC devices and interfacing to temperature sensors including RTDs, thermistors, and solid state devices.
Microcontroller and DSP hardware design techniques.
Experience with standard serial interfaces: RS232, RS422, USB, I2C, SPI
Familiarity with PC/104, IDE, STD and PCI bus standards.
Experience interfacing electrical control circuits with robotic and fluid handling systems is desired.
Electrical hardware design experience with off the shelf embedded computer systems, single board computers, and their associated hardware peripherals, such as LCD touchscreens, and storage devices.
Experienced in digital logic circuit design using micro-controllers, DSPs, CPLDs, FPGAs, etc..
Experience in small signal analog conditioning circuitry design and the application of A/D and D/As.
Embedded programming experience in Assembler, VBASIC, C, C++, and VHDL languages.
Optical Engineering background with experience in fluorescence based detection systems is advantageous
EDUCATION:
A Bachelors Degree in Electrical Engineering with a minimum of ten years relevant experience, or MSEE with five years relevant experience.
Minimum two years experience leading engineering development teams.
Biotech Company in Gaithersburg, MD is looking for a Sr. R&D Scientist for R&D and interpretation of Clinical Chemistry. This position will require heavy experience with LC/MS and preferably some history of interfacing with clients.
The Sr. R&D Scientist will be working with human samples (blood and urine). An academic background will be considered, but the preference is for some industry experience. Previous management experience is not required as this position will mainly involve benchwork.
Requirements:
M.S. or Ph.D in Biology/Chemistry
10+ years laboratory experience
Ability to run LC/MS and train others on LC/MS
Comfortable interacting with clients
Knowledge of/experience with spectrophotometry, electrophoresis and various immunoassays
Position Details
Our client will have data submitted from critical care investigation networks. Time sensitive and complex secondary analyses will be performed within the Emergency Care Coordination Center. The chosen candidate will act as Project Manager to perform analyses, integrate data with other data sources and to perform additional analyses and prepare reports of aggregate data for frontline clinicians. The chosen candidate will serve as a technical expert in clinical investigation, multi-center studies and biostatiscal methods for the Emergency Care Coordination Center.
Responsibilities
Responsible for proposing a reporting format and mechanism to disseminate information regarding H1N1 critical illness to client personnel and state/local public health agency partners, as well as front-line clinicians.
Prepare time sensitive and secondary analyses of H1N1 critical illness clinical data as needed.
Prepare periodic reports of H1N1 critical illness aggregate patient data.
BEST INDUSTRY Biostatistics
BEST DEPARTMENT Consulting
Qualifications
MD or PhD is required.
5 years as Principal Investigator or a senior-level role in multi-center clinical studies.
10 years experience in epidemiology/biostatistics is required.
Experience and capability to conceptualize and perform sophisticated bio-statistical analyses of clinical databases.
Multi- variable analyses such as Cox proportional hazards and logistic regression is required.
Competency with survival analysis is mandatory in this role.
Proficiency with MS Office, MS Access, Project Visio, Endnote and other statistical software (i.e. STATA, SPSS, SAS, etc.) is essential in this role.
Strong project management skills are required.
Knowledge of clinical investigation methodology, especially for critical illness investigation is required.
Experience working in a team environment is required.
Very strong communications skills, verbal, written and interpersonal are essential in this role.
Experience in writing for publications is a very strong plus and highly preferred.
Excellent organizational skills are required.
Good written and oral communication skills, the ability to work well in teams, demonstrated technical aptitude and a strong work ethic. Good organizational skills and excellent attention-to-detail. Some experience handling and performing basic manipulations with laboratory rodents is strongly preferred. Familiarity with preclinical drug development is a plus. AALAS certification is a plus.
Job Summary:
The Lab Technician will provide husbandry and technical in vivo support for early stage preclinical research. The husbandry tasks include performing daily health observations, cage changing, performing facility sanitation procedures and maintaining accurate records. The technical tasks include performing procedures on laboratory rodents such as handling, dosing via multiple routes, clinical health assessments, biologic sample collection and necropsy. The Lab Technician will also be responsible for review and compliance with all applicable SOPs, business practices and company policies.
Biotech company located in Rockville, MD is looking to hire a Manufacturing and Process Development Associate to join their company immediately. We are looking for someone with 2-5 years of experience in Biomanufacturing and experience working in a GMP environment. A strong work history, good communication skills and solid work ethic are the characteristics that we value most.
The American Red Cross Greater Chesapeake and Potomac Blood Services Region is seeking a
dynamic Biomedical Equipment Technician to become a part of its Equipment Managment Team!
Job Requirements:
~ Associates degree in electronics or equivalent necessary
~Two years of related electronic repair expereince
~Advanced knowledge of electrical circuitry, common test equipment
~Basic writing, communication and computer skills necessary
~Valid driver's license with a clean MVA record
Hours:
Mon-Fri 8:30am - 5:00pm
To apply, please email your resume to: jobs@usa.redcross.org. Please referece job code BET.
Laboratory in Baltimore, MD has a position available for a Pathology Assistant to begin immediately. This position requires 1-2 years of recent experience handling and preparing slides and specimens. Specific experience staining slides is required as well.
Qualifications:
Bachelor's or Masters degree in a scientific or technical discipline with 5-10 years experience is required.
Previous experience in Quality Assurance required.
Strong interpersonal skills and ability to effectively interact with FDA and company personnel at all levels required.
Excellent technical writing and strong verbal communication skills are a must.
Job Responsibilities
This position's primary focus is to provide quality, efficient service to our customers and to support the other Service, Technical Support, and Sales & Marketing staff in the performance of the same. Will work directly for the Regional Service Manager and will work in conjunction with the Shimadzu Biotech Management as needed.
Education and/or Experience
BS degree in Chemistry or a closely related field preferred and at least three years of field exposure supporting MS instruments, or the equivalent experience.
Knowledge Requirement
Incumbent must be proficient at effectively troubleshooting and resolving instrument problems, performing installations, and providing, when necessary, customer and staff training. Incumbent must also be capable of successfully running standard samples and be able to resolve basic applications related customer problems.
The essential function of this position is to support the product line taking by responsibility to coordinate marketing and technical aspects to include, phone support, product sales support, training, applications, repair, maintenance, installation and phone support of assigned products sold by Shimadzu Scientific Instruments.
Education and/or Experience:
Incumbent must have a Bachelors degree in the physical or natural sciences with at least two years of technical applications experience in the appropriate product line or the equivalent experience in maintenance and/or repair of analytical instrumentation.
Knowledge Requirement:
Incumbent must be proficient at effectively troubleshooting operational, application and other instrument problems in a methodical efficient manner. Additionally, incumbent must be able to act independently in matters not governed by policy to ensure customer satisfaction.
Shimadzu Scientific Instruments Inc. is an EOE - M/F/D/V.