Internships

Atossa Genetics is a women’s healthcare company specializing in the development of proprietary medical devices and laboratory services to stratify, assess, profile, and monitor the breast health in patients.

We accept enthusiastic, high quality undergraduate or graduate students interested in learning the industry as interns. Stipend may be awarded depending on the skills and experiences. Please send your resume and contact information for two references to internship@atossagenetics.com.

Current Opportunities

MARKETING DIRECTOR

This position is pivotal in the organization as the driver for strong augmentation of Atossa’s value propositions as well as the precise segmentation of the customer groups to address. The Marketing Director will help the organization achieve its mission of improving women’s health. A number of marketing and product management projects will be brought to the finish line by the successful candidate.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Own and drive various product development projects, including FullCYTE, ForeCYTE, NextCYTE, and PGx
  • Drive pharmacogenomics enhancement projects
  • Be instrumental in identifying & engaging selected opinion leaders (KOLs), in close collaboration with other Company departments
  • Create and define projects necessary to complete company objectives and time lines to be followed
  • Ensure that all marketing communications (web site, social media, printed materials) have the strongest possible message enticing customers to seriously consider Atossa’s solutions in their clinical decision making
  • Be instrumental in bringing projects to the finish line, while making sure all compliance requirements are met
  • Work collaboratively and creatively with compliance in order to deliver best message to customer
  • Demonstrates strong teamwork and the ability to coordinate projects domestically and globally
  • Must be a self-starter who is able to operate without daily direction
  • Understanding of highly regulated environment and adherence to all applicable laws & guidelines
  • Follow Company HIPAA, Sales and Marketing, and other compliance guidelines
  • Comprehensive understanding of compliance standards
  • Participate in trade show, conferences, and other related meetings to promote and support company brands, both in the USA and occasionally abroad

Education, Experience and/or Skills Required

  • Bachelor’s degree required in marketing/ business administration, or relative work in the marketing field
  • Minimum of fifteen years of marketing experience in medical devices and/or pharmaceuticals or life sciences, with 5+ years in leadership role
  • Experience in women’s health preferred
  • Travel as required (25%). Mostly domestic and some to Europe

To apply for this position please send your resume to hr@atossagenetics.com.

QUALITY ENGINEER

Under the direction of the Manager, Quality Assurance & Regulatory Affairs, the Quality Engineer provides Quality System leadership and guidance with respect to pharmaceutical development and projects to the following functional groups: Manufacturing, Engineering, QA/RA, and Supply Chain teams. Support medical device QA activity and tasks as required and/or directed.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Provides Quality oversight/guidance with respect to pharmaceutical API and CMC manufacturing in accordance with 21 CFR 210/211.
  • Able to combine input from multiple sources to provide solutions to teams and manufacturing facility regarding product quality, design, and supply chain activity for both pharmaceuticals and where necessary medical devices.
  • Develops reviews and approves work for inclusion in both Drug Master Files (DMF’s) and medical device Design History Files (DHF’s) where necessary.
  • Communicates significant issues or developments identified during quality assurance activities and provides recommended improvements for CMO’s with respect to activities outlined above.
  • Provides Quality Engineering guidance to functional teams throughout the product development process (PDP) to ensure compliance to the required PDP deliverables, resulting in the development of safe and effective pharmaceuticals and where required medical devices.
  • Administrator of the ECO/DCO process, Label Reviews and provides guidance to functional teams throughout the product development process (PDP) to ensure compliance to the required PDP deliverables, resulting in the development of safe and effective pharmaceuticals and where required medical devices.
  • Conducts, Develops, Participates, Reviews and approves validation documents and reports with respect to pharmaceutical products and where required medical devices.
  • Assists functional groups during FDA Inspections, ISO audits etc. to provide objective evidence required during those activities
  • Ability to travel (50%) to suppliers and CMO locations.

Education, Experience and/or Skills Required

  • BS in Chemistry, Life Science and/or Engineering or equivalent experience in a pharmaceutical and/or related environment.
  • Seven or more years of relevant pharmaceutical experience with API and CMC or related medical device experience.
  • Aseptic filling operations and CMC experience in the pharmaceutical industry.
  • Working knowledge of Quality concepts, regulatory compliance requirements and tools including FDA Drug GMP’s, ICH Guidelines, Good Clinical Practices, FDA QSRs, ISO 13485:2003, Medical Device Directives, Canadian Medical Device Regulations, etc. as applicable.
  • Completely proficient in product & process development concepts, including change control and risk management for pharmaceuticals and/or medical devices.
  • Applies organizational and technical knowledge to move teams through issues.
  • Problem solving abilities applying statistical techniques to address issues and investigations.
  • Excellent written and verbal communication skills including ability to communicate technical information.
  • ASQ Certified Quality Engineer preferred.

To apply for this position please send your resume to hr@atossagenetics.com.

DIRECTOR, CLINICAL OPERATIONS

With oversight from the VP, Clinical Research and Development this position will manage the operational aspects of clinical study conduct from selection and qualification of vendors and investigational sites through finalization of clinical study reports.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Provides guidance and oversight for the management of clinical trials within departmental budget and timeline – clinical trials at Atossa Genetics include drugs, diagnostic devices and accompanying laboratory tests
  • Contributes to successful development, implementation, execution, oversight, monitoring and completion of clinical trials
  • Assists in the development and implementation of SOPs for clinical trials and related activities
  • Leads in the creation of a multi-year Clinical Development Plan for development
  • Participates in and sometimes leads the development of Protocols, Clinical Study Reports, INDs, NDAs, and other clinical, regulatory, and safety documents
  • Assists in developing abstracts, presentations, and manuscripts
  • Develops professional clinical/scientific relationships with the Principal Investigators and their staff
  • Participates in interactions with regulatory agencies
  • Assists in the development of FDA documents (e.g., briefing documents, IND, NDA) and study related documents (e.g., Investigator Brochure, CRFs, protocol, CSRs, etc.)
  • Works with sales and marketing to provide key review and feedback for new indications and promotional materials

Education, Experience and/or Skills Required

  • Bachelor’s Degree in Scientific/Health related field. Advanced degree preferred
  • 10+ years Clinical Research/Development experience required, including relevant Clinical Trial Project Management experience
  • Experience in a global or similarly structured organization
  • Knowledge of Good Clinical Practice (CGP) and FDA regulations is expected. Experience with Institutional Review Board (IRB) preparations and submission preferred
  • Experience writing, reviewing and editing clinical protocols and study reports
  • Ability to exercise judgment and determine appropriate action
  • Excellent written and verbal communication skills, including ability to effectively present information and respond to questions from project teams, external vendors, KOLs, and customers
  • Ability to work independently and manage deadlines
  • Approximately 25% travel. International travel required

To apply for this position please send your resume to hr@atossagenetics.com

SALES ACCOUNT SPECIALIST, LABORATORY SERVICES

This position will work with the SVP, Sales & Marketing to increase sales revenue by promoting lab tests to a physician customer base.

Essential Duties and Responsibilities include the following.  Other duties may be assigned.

  • Market the Company’s pharmacogenomic and women’s health laboratory services to general practitioners (MD, DO, ND), physicians, family practice, OB/GYN and breast centers within the geographic marketplace of  assigned area
  • Meet with a  minimum of 45 physicians weekly marketing laboratory pharmacogenomics services
  • Complete monthly reports with format to be determined by manager
  • Attend weekly meetings discussing strategies, success, and challenges
  • Train, with Medical Director oversight, clinicians on sample collection guidelines
  • Ensure proper documentation completed when setting up new customer accounts
  • Provide weekly and monthly forecasts
  • Work with assigned Clinical Liaison in territory as needed
  • Input customer meeting notes into company CRM system (SalesForce)
  • Manage sales operations within assigned territory
  • Prospect leads to expand sales  using purchased database
  • Build relationships and identify the prospect’s need for our products and services
  • Develop and utilize presentation skills to successfully position our products
  • Provide customer with product literature and have the ability to discuss the points that are most relevant to customer’s situation

Education, Experience and/or Skills Required

  • Bachelor’s degree required
  • Minimum 2 years’ experience in full cycle sales
  • Solid sales presentation and communication skills, both verbal and written
  • Proven track record of success in meeting assigned sales quotas
  • Strong relationship management skills
  • Ability to self-manage
  • Proficiency using a CRM system
  • Excellent customer service skills

To apply for this position please send your resume to hr@atossagenetics.com