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.com.

Open Positions:

Summary Description:

ASELL is seeking an experienced and highly motivated IVD Product Development Scientist to work on a team developing cutting edge diagnostic products for regulated markets. The candidate will have a strong understanding of regulated product development and associated quality system regulations, a broad understanding of biology and/or biotechnology, strong writing skills, and the ability to collaborate effectively as part of a cross functional team.

Essential Duties & Responsibilities:

  • Provide technical expertise in support of new product development, verification, and validation activities, focused on IVD devices that use cellular, molecular, and/or immuno assays.
  • Support and lead parts of design-controlled product development efforts including definition of proper and testable product requirements, definition of product development milestones, conducting design reviews, and rigorous testing & analysis in support of verification and validation activities.
  • Oversee and direct lab activities and experiments, as needed, to support product development, and support lab testing when needed.
  • Coordinate the efforts of multidisciplinary teams of internal resources and external partners/subcontractors to successfully execute product development activities.
  • Deliver analyses, test results and reports that support design control compliance with regulatory guidance.
  • Author design verification and validation protocols and reports, design inputs, design outputs, specifications, risk documents, package inserts and regulatory submissions.
  • Identify potential collaborators for technology and product development efforts.
  • Perform technology assessments and make scientifically supported recommendations for promising technologies and initiatives most likely to achieve customer and company objectives and requirements. Stay informed of current state of the art in relevant scientific and technical areas.

Minimum Qualifications:

  • Bachelor’s degree in Biology, Chemistry, Biomedical Engineering, or related field
  • 5+ years of experience with IVD development
  • Prior history working in an FDA and/or ISO regulated development environment; specifically, 21 CFR 820 and ISO 13485
  • Knowledge of FDA 510(k)/PMA/De Novo process preferred
  • Verification and Validation experience with FDA-cleared or approved IVDDs
  • Experience with designing and running lab experiments

Additional Attributes:

  • Ability to interact with multidisciplinary colleagues in a team environment
  • Proficient organizational, record keeping and communication skills (oral and written), with excellent presentation technique
  • Strong work ethic to generate high quality work under tight deadlines
  • Demonstrated leadership and self-motivation. Ability to motivate and guide others to meet objectives and drive actions to closure
ASELL is a medical device developer that is working with government customers to turn science into solutions. ASELL is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, or national origin.

Summary Description:

Under general supervision, performs lab experiments, prepares media and reagent solutions, and maintains appropriate sample testing documentation.

Job duties:

  • Responsible for performing laboratory testing activities, with a focus on in vitro diagnostic applications
  • Plan and execute laboratory experiments and studies
  • Support and interact with other team members to support testing activities
  • Generate test reports and summarize key findings and experimental study outcomes

Required Knowledge and Skills:

  • Working knowledge of general laboratory equipment and aseptic laboratory techniques
  • Mathematics and statistics skills
  • Experience in Molecular, Microbiology, Cell Biology, or related sciences
  • Experience with cell culturing, microscopy, and ELISA assays is preferred
  • Knowledge of basic lab operations and associated health and safety procedures
  • Demonstrated experience in handling clinical biological specimens using appropriate precautions
  • Experience with Microsoft Office products, such as Word, Excel, and PowerPoint

Required Qualifications:

  • Bachelor’s Degree (preferred) or Associate’s Degree in Biology, Molecular Biology, Biochemistry, Microbiology, Chemistry or related science from an accredited college or university from an accredited college or university
  • A minimum of 1 year of professional experience as a lab technician, or an equivalent combination of training and experience.

Additional Attributes:

  • Ability to interact with colleagues in a team environment
  • Must have excellent attention to detail and ability to carefully and accurately carry out instructions
  • Proficient organizational, record keeping and communication skills (oral and written), with excellent presentation technique
  • Strong work ethic to generate high quality work under tight deadlines
  • Demonstrated self-motivation
ASELL is a medical device developer that is working with government customers to turn science into solutions. ASELL is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, or national origin.