Applied Biomimetic Inc. (www.appliedbiomimetic.com)

Applied Biomimetic is an international biomimetic engineering group that builds upon a simple but powerful concept: Nature’s ability to separate chemical elements at the molecular level using highly specialized proteins as tools such as the selective aquaporin water channel that brought the 2003 Nobel Prize in Chemistry to its discoverer.

AB has developed a concept where they maintain the superior water transport capabilities of the aquaporin water channel while embedding it into a robust polymer structure thus allowing the company to make membranes applicable for industrial purposes.

AB is focusing on the development of a wide range of applications for its patented technology. The aim is to provide disruptive solutions for the water treatment, health, food, and other industries enabling these industries to enhance their products, reduce costs, and save energy. The membranes are designed to withstand changing and sometimes harsh environment in various industrial applications.

In order to further strengthen our protein team AB is looking to hire an experienced individual in protein chemistry to help further develop and scale-up our protein activities.

AB Inc. has more than 10 employees.

Work Location The AB main office is located in Gaitherburg, Maryland.

Reporting Structure This position is a direct report line to company’s Chief Scientific Officer (CSO) Main tasks and responsibilities:

• Understanding and development of comprehensive R&D plans.

• Knowledgeable of and experience with membrane protein expression, purification and characterization.

• Genetic manipulation of membrane proteins

• Responsible for designing and implementation of experiments, including internal coordination, task distribution to technicians, completing deliverables, meeting milestones, and overall timelines.

• Perform robust analysis of data from lab experiments, and being responsible for documentation and reporting of technical progress and results

• Accountable for project deliverables, and communicate status and other related information to management and project team members

• Being focused on details and efficiency in the laboratory as well as having an interdisciplinary approach to the tasks at hand while exercising good laboratory practice. The qualified candidate must have:

• Ph.D. in bio-chemistry or molecular biology (or similar) with several years of experience in either industry or post-doc positions, and the potential to develop into R&D manager

• Good communication and team working skills • Ability to thrive in a fast paced environment, work short cycle times and flexible hours if required, and deliver results under pressure

• Ability to work independently and maintain a high level of quality in work

• A desire to work in a start-up company

• US work permit Preferred Skills and Experience:

• Knowledge of and experience with optimizing protein manufacturing processes with specific focus on membrane proteins

• Knowledge of and experience with genetic manipulation of protein expression systems

• Knowledge of and experience with colloidal science (lamellar phases)

• Experience with one or more of the following laboratory instruments: SFLS, FPLC, HPLC, spectroscopy, microscopy, etc.

• Results oriented and with excellent analytical skills

• Self-motivated with drive, and a natural curiosity and interest in new technology and ground-breaking scientific developments. In addition to a challenging and interesting work environment and the opportunity to work on ground-breaking technology we are offering an attractive compensation and benefit package incl. health, dental and 401k etc.

Please forward your resume to: This email address is being protected from spambots. You need JavaScript enabled to view it.

Responsibilities:

The Director of Biostatistics provides direction on product development plans, protocols and analysis, reviews study reports and regulatory submission materials, and ensures that standard procedures are followed within projects. This position is responsible for implementing consistent statistical conduct for testing implementation throughout the organization. The position also provides guidance to the department towards achieving departmental and corporate visions and goals. The Director maintains liaison with research and development, clinical laboratory, and quality assurance personnel in order to identify and meet their needs for statistical support.

Key Responsibilities:

Draft statistical analysis plans and use advanced statistical techniques to analyze clinical laboratory data as well as product verification and validation study results.
Provide strategic input to development programs including filing strategies worldwide, study design, analytic methods, and endpoints that meet both regulatory and scientific requirements.
Collaborate with functional areas within the company (Clinical Laboratory, Regulatory and Research and Development).
Make presentations and represent biostatistics to senior management, external collaborators and thought leaders, FDA meetings, FDA advisory boards and medical and statistical meetings.
Provide statistical direction and technical oversight for complex projects requiring statistical input.
Support the presentation and publication of study results and contribute to advances in statistical topics.
Ensure the scientific integrity of the statistical methodology applied to clinical trials, verification and validation protocols, and other key product tests.
Strategically select resources to provide for analytic needs, and clarify long-term resourcing plans.
Clarify project deliverables and timelines for statistical analysis and reporting, and ensure that they are met.
Provide leadership and direction for organization strategic initiatives.
Job Requirements:

A Ph.D. degree in Statistics, Biostatistics or equivalent areas with 5+ years or MS degree with 10+ years of relevant industry or FDA experience in the statistical analysis of biomedical data.
4+ years of scientific programming experience with SAS.
Diagnostic experience in oncology and submission experience with PMAs and companion diagnostics are preferred.

Apply for Job

We are currently seeking extraordinary, highly motivated individuals to join our research and development team, with a focus on tissue and cell-free DNA liquid biopsy approaches. The successful candidate will develop and optimize cutting-edge diagnostic technologies for use as an IVD. Background in product development for Class II and III assays is preferred. Expertise in design control desired.

Core Qualifications:

Master’s or Ph.D. Degree in Biology or Related Field with a minimum of 1-3 years’ experience in molecular diagnostics or medical device industry
Experience in 510k, PMA submissions, and FDA interactions preferred
Design control, verification and validation protocol expertise required
Expert knowledge of scientific principles and concepts
Oncology and/or diagnostics experience strongly preferred
Experience with next-generation sequencing technology and bioinformatics analyses of cancer strongly preferred
Cross-functional experience working with product development teams

Apply for job

A fast-growing company is seeking a motivated individual to assume a highly visible position with significant cross-functional team interaction and opportunity to impact the future success of Personal Genome Diagnostics.

This individual will report directly to the Senior Vice President, Corporate Development and support core initiatives which are critical to the successful development and implementation of strategies for the expansion of the business.

Key responsibilities include:

Completion of market research and application of decision analytical methods to support evaluation of strategic business opportunities
Creation of comprehensive business cases to support the evaluation of business development and strategic alliance opportunities including market forecasts, NPV, IRR, deal structures, etc.
Monitoring and reporting of competitive activities and milestones in the diagnostics and related markets to support internal go/no go decision making
Development and maintenance of timeline of all key Company milestones covering early research, development, regulatory, marketing, sales and financing initiatives
Collaboration with research, technical, development, regulatory and commercial colleagues to ensure appropriate progress is being made against defined strategies and proactively raise issues and recommendations for resolutions
Partner closely with internal stakeholders to monitor and manage timelines, resource plans, critical path activities, and risks to support annual strategic plan
Creation of materials to support corporate development activities, executive briefings, fundraising, business development and other initiatives

PGDx is located in Baltimore MD and offers competitive salaries, vacation/holiday pay, medical benefits and a stimulating work environment.

Skills/Education/Experience Requirements:

5+ years of experience in the diagnostic or biopharmaceutical industry with 3+ years in business analysis, market research, new product planning, forecasting and/or business development
Ability to engage with multi-disciplinary teams in the execution of operational plans; ideally across multiple functional areas and various development phases.
Demonstrated success in the ability to thrive in growth stage life science company
Proactive individual capable of taking the initiative and driving to results
Demonstrated experience managing programs to agreed timelines and within scope
Strong organizational and time management skills to maintain a high level of productivity and innovation in order to complete assignments in a timely manner
Exhibits high degree of initiative, strong drive, and follow-through
High level of competency in PowerPoint, MS Excel, MS Project, etc.
Degree in a scientific discipline, with an MBA or comparable experience

Apply for job

155 Gibbs Street, Suite 433
Rockville, MD 20850
www.reveragen.com

Located in Rockville town center, ReveraGen is a fast-growing clinical-stage drug development company with a focus on developing therapeutics for Duchenne muscular dystrophy. We run under a venture philanthropy model, through collaborations and partnerships with non-profit foundations and government agencies in both the US and the EU. We are currently looking for self-motived professionals to join our young, energetic and diverse team.

Position Open: Project Coordinator

Main Duties:

• Takes responsibility and manages defined projects
• Keeps track of and coordinates projects by follow up on tasks and results, tracking and recording the projects’ progress by proper tools and software, and reports deviations back to the Vice President of Operations.
• Creates, revises and implements standard operating procedures
• Produces information by transcribing, formatting, inputting, editing, retrieving, copying, and transmitting text, data, and graphics.
• Represents the the Vice President of Operations in the absence of the Vice President of Operations.
• Protects operations by keeping information confidential.

Requirements:

• Pharmaceutical or clinical research background preferred
• Excellent communication skills (both oral and written)
• B.S. or B.A. Degree required
• Familiar with Microsoft Office software package (Outlook, PowerPoint, Word, Excel)
• martsheet knowledge/experience is a plus

Position & Company Description

Sonavex is seeking to hire a Senior Software Engineer to support development of current and future medical device software packages. The company is a Johns Hopkins University spin-out simplifying point- of-care ultrasound imaging to increase its utility for new perioperative applications. The company's first product, EchoSure, detects post-operative blood clots prior to catastrophic surgical failures. Pipeline technologies include surgical navigation and perfusion assessment products.

The company has raised a Series A financing round and has received numerous prestigious government grants from the National Institutes of Health and National Science Foundation to advance its technology.

The successful candidate will work directly with the Director of Research & Development on a daily basis, and will regularly work with Johns Hopkins professors and surgeons on the team.

Compensation

Employee compensation will be dependent on level of experience. The compensation package will include a competitive combination of salary and equity.

Responsibilities

The Senior Software Engineer will report directly to the Director of Research & Development to complete Sonavex’s lead product. The candidate will also have the opportunity to lead development on pipeline navigation and tissue perfusion assessment products. Specific responsibilities include:

• Develop commercial custom ultrasound software for new surgical applications

• Opportunity to lead development of pipeline products

• Participate in bench and animal studies

• Document technical designs, programming tasks and procedures

• Report and communicate methods and results

• Perform verification and validation testing per FDA requirements

• Perform unit testing and performance testing, with high quality and on schedule

• Participate in design reviews

• Participate in algorithm implementation and design

• Report directly to the Director of R&D

• Analyze project tasks, provide estimates of scope, work efforts and dependencies

• Collaborate closely with other team members to design and optimize code

• Update job knowledge by studying state-of-the-art development tools, programming techniques, and computing equipment; read professional publications

Qualifications

The ideal candidate should have a strong background in software engineering, ideally with experience in ultrasound physics and/or image processing. Specific qualifications are listed below:

Required

• PhD, MS or BS in CS/EEE or similar experience

• 3+ years of experience developing complex/multithreaded C++ code for real-time systems

• Proficient in Linux

• Strong knowledge of data structures and algorithms

• Deadline and detail oriented

• Enjoy a small, fast-paced, high-growth start-up environment

• Team player who enjoys working with a diverse and intelligent team

Preferred

• Medical device development experience

• Experience with GUI development using Qt

• Experience in medical image processing using ITK

• Experience with OpenCV

• Multi-thread Programming

• VTK or OpenGL

• Comfort with Matlab

• Experience with CUDA GPU programming

• Technical comprehension of ultrasound physics and beamforming

• Background in or comfort with Doppler ultrasound processing

• Signal/RF processing

• Ultrasound image processing

• Image segmentation and registration

• Computer Vision

Location

The employee will work out of Sonavex’s office in Baltimore, Maryland.

Application Process

All interested applicants should send their resume, salary requirements, and optional cover letter to:

David Narrow CEO

Sonavex, Inc This email address is being protected from spambots. You need JavaScript enabled to view it.

The Reimbursement and Payer Manager will participate in the development and deployment and utilization of reimbursement tools, models and case studies regarding Epi proColon to address laboratory, MD and patient needs.

In the role they will develop and maintain a database of all state, Medicare and private payer group payment policy and practices for associated CPT codes.

As part of the Commercial Team they will optimize the medical economic positioning and messaging for Epigenomic assays including Epi proColon.

They will lead the interaction with external resources to develop assay specific tools/medical economic models for Epigenomics’ assays.

Establish and deliver “reimbursement support packages” and presentations to be delivered by the individual and Area Managers to payer organizations and prospects.

As part of their responsibility they will develop tools to support laboratory reimbursement staff in securing payment for Epigenomics assays.

Lastly, they will develop education tools and tactics to address Medicare, Medicare Advantage, private pay and Medicaid implementation issues for epi proColon.

Requirements: The ideal candidate will have 5-10 years of experience in either Medical Insurance Payment or Laboratory Payment. They will have intimate knowledge of national and local payer practices for private pay and Medicare insurance programs. They will be able to travel 20% of the time.

Compensation: Combination of salary and annual bonus at market levels.

Please submit resumes to This email address is being protected from spambots. You need JavaScript enabled to view it.