WE’RE ALWAYS LOOKING FOR TALENTED PEOPLE TO JOIN OUR TEAM!

We are proud of the work that we do, and wouldn’t be successful without our amazing team of dedicated people. If you’ve got the desire to be a part of a creative and innovative group of people in a fun and rewarding environment, then send your resume to careers@asell-llc.com.

Open Positions:

Director, Quality Assurance & Regulatory Affairs

  • Job duties:
    • Lead all Quality Assurance (QA) and Regulatory Affairs (RA) activities in support of the development of an in vitro diagnostic device (IVDD)
    • Lead the implementation of a Quality Management Systems (QMS) that complies with the FDA’s quality system regulations (e.g., 21 CFR 820) and ISO 13485.
    • Ensure compliance with the FDA QSR and ISO 13485 during development, validation, production and sustainment efforts
    • Lead team with focus on FDA regulation compliance and successful FDA device clearance
    • Lead regulatory affairs activities that lead to a device clearance or approval from the FDA
    • Lead regulatory affairs activities that lead to a device clearance or approval from foreign regulatory authorities (e.g., CE mark)
  • Required Skills:
    • RA/QA experience with FDA-cleared or approved products
    • Knowledge of scientific, regulatory, clinical, quality and process development aspects of IVD product development
    • Experience in quality control and documentation of design and results in a FDA regulated environment
    • Strong aptitude with Microsoft Office products, such as Word, Excel, and PowerPoint.
  • Recommended Skills:
    • Experience with reagent and assay development
    • Experience overseeing and auditing RA/QA activities at external suppliers or development firms
  • Qualifications:
    • Bachelor’s degree in related field
    • 5+ years RA/QA experience in IVD industry while working on an FDA cleared or approved device
  • Additional Requirements:
    • Ability to interact with colleagues in a team environment
    • Must have experience in managing and collaborating with diverse organizational elements / groups and resolving conflicts within teams
    • Must have excellent organizational, record keeping and communication skills (oral and written), with excellent presentation technique
    • Must have a strong work ethic to generate high quality work under tight deadlines
    • A proactive attitude
    • Must have demonstrated leadership and self-motivation. Possesses the ability to motivate and guide others to meet objectives
    • Must have demonstrable project management and creative problem solving skills.

Director, Business Development

  • Summary Description:
    • Entrepreneurial, energetic self-starter to act as ‘Chief Growth Officer’ for a small biotech business that currently has a strong foundation in a narrow niche. The key focus of this cross-functional position is diversifying and growing the company’s business base.  Must be comfortable working at both tactical and strategic levels across both technical and business domains to become a key member of a small, collaborative, and dynamic team.
  • Job duties:
    • Assess and prioritize new opportunities and ventures that will enable the company to diversify and grow.
    • Ensure that analyses of business opportunities are based on a strong understanding of customer needs, market potential, competitive & regulatory barriers, and required investments.
    • Use industry knowledge and business acumen to make recommendations for strategic actions such as but not limited to forming partnerships, making R&D investments, and licensing technologies to gain access to new products/capabilities that will position the company for future success.
    • Lead the preparation and submittal of proposals and grant requests. Apply creativity and ingenuity to define ‘win themes’ and ‘win strategies’ to guide the preparation of the submittal.  Generate the proposals/ grant requests by coordinating the activities of others, and also by independently generating proposal content.
    • Cultivate a network of customer, user, and industry contacts to stay current on the market landscape and to support competitive analyses and recommendations for business pursuits.
    • Represent the ‘voice of the customer’ in company activities such as the generation of product requirements, the preparation of proposals/grant requests, and the creation of PR campaigns.
    • Portray the ‘voice of the competition’ when considering new ventures. Help create a clear understanding of barriers to entry and recommend strategies to overcome them.
    • Lead the company’s marketing/PR programs including advertising, social media, presentations at conferences and forums, publishing technical papers, etc.
  • Required Skills and Experience – the ideal candidate will have:
    • A strong scientific/technical foundation along with a record of business success.
    • Experience in the growing a medical device business, preferably in IVD industry with an FDA cleared or approved IVD test.
    • Knowledge of product development practices, techniques, and standards in the medical device industry.
    • Demonstrated ability to be an independent contributor and to also work well in a team environment.
    • Excellent technical writing, communication & presentation skills.
    • Strong aptitude with Microsoft Office products, such as Word, Excel, and PowerPoint.

ASELL is a medical device developer that is working with government customers to turn science into solutions.  ASELL, LLC is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

www.asell-llc.com