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

VP, Global Quality Assurance & Regulaotry Affairs

The Vice President of Global Quality Assurance and Regulatory Affairs (VP QA/RA) will lead and manage the Regulatory, Quality Control and Quality Assurance functions for the organization. The position includes responsibility for the refinement of regulatory strategy working in collaboration with the CEO and other senior management, for implementation insuring compliance with pertinent regulations, standards and clinical practice guidelines. This role is responsible for the Quality and Regulatory Compliance of products and services developed, produced, tested, and released for pre-clinical and clinical trials and, ultimately, for commercial use. This role is also responsible for driving the quality and regulatory activities for the Quality Management System (QMS) implementation across the Organization and ensuring contract manufacturer(s) are in compliance.

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

  • Design and implement the interface with regulatory authorities. Function as the Regulatory Affairs representative on project teams; and will manage the Regulatory Affairs coordination with partner companies and vendors.
  • Lead responsibility for the content, production, assembly and administration of worldwide regulatory submissions, overseeing all aspects of ongoing and new regulatory submissions, U.S. and International 510(k), TPG licensing, CE marking.
  • Foster a culture of excellence, professional integrity, and respect for patient safety and will insure that all necessary management systems are in place to make these high principles actionable and assure the compliant practices that will result in the Company’s ultimate medical and commercial success.
  • Provide strategic direction and guidance to Executive Management regarding quality & regulatory timelines for new and revised products and/or processes, and/or regulations & guidance’s.
  • Establish, maintain and monitor ongoing Company-wide quality and compliance policies with applicable regulatory agencies, and other international quality compliance requirement for other countries including reporting, records, training, systems and processes that ensure the Company’s quality system is functioning properly.

Education, Experience and/or Skills Required

  • Bachelor’s degree in in a relevant area of science or medicine, and additional credentialing in management or the regulatory affairs profession which provides the professional insight and credibility necessary to successfully lead the function. An advanced degree is preferred.
  • Fifteen years’ experience in Quality Assurance and Regulatory Affairs in roles of increased responsibility with at least three to five (3-5) years’ experience at the VP level or above.
  • Direct experience with drug regulatory submissions and product approvals worldwide including a track record of effective collaboration with regulatory agencies globally.
  • Experience preparing FDA 510k and CE mark submissions and documentation and international device license and registration.
  • An overall understanding of Quality requirements with respect to FDAs Quality System Regulation, ISO-13485—2003, as well as Global medical device regulations and directives.
  • Demonstrated expertise in the management of a pharmaceutical industry regularity affairs function, including building and leading regulatory affairs, QC and QA teams.
  • Travel up to 30% to domestic and international operations & suppliers.

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