Product Development Associate - Biomerica Inc

Job Summary

Since 1971, Biomerica has developed, manufactured, and distributed medical diagnostic products for the early detection and monitoring of chronic diseases and certain medical conditions. Our focus is to design and distribute products intended to enable prevention and early detection of diseases. Improving quality of life is instrumental to our success. We are a fast-growing NASDAQ traded global company that drives innovation in diagnostics in Gastrointestinal and Inflammatory Diseases.

This job position is highly cross-functional interfacing with our technical support and product development teams in a fast-paced work environment. Job duties include performing non-routine lab procedures for the development and optimization of immunoassays in support of new product development and clinical feasibility studies.

Essential Duties and Responsibilities

Biomerica, Inc. is looking for a motivated, adaptable, and detail-oriented individual to be a part of the Product Development team. As member of the Product Development and Technical Support Team, the Product Development Associate reports to the Product Development Supervisor and is responsible for the following tasks.

1. Participation in the development and optimization of immunoassays in collaboration with others on assigned projects.  Meets deadlines specified in overall project schedules.
2. Make contributions to the planning, execution and interpretation of simple and complex experiments that contribute to project strategies. May plan and execute simple experiments independently.
3. Make detailed observations. Analyzes data using statistical methods. Interprets results and documents conclusions.
4. Maintain strict laboratory notebooks and research records. Performs laboratory procedures and practices in compliance with Quality System requirements and standard written laboratory procedures and protocols. 
5. Contribute to, and may prepare independently technical reports, summaries, protocols and quantitative analyses that accurately and clearly communicate necessary information.
6. Participate in creation of all necessary documentation to support product manufacture, including manufacturing specifications, QC test procedures, raw material specifications and validation protocols.
7. Apply professional concepts, in accordance with Biomerica objectives to solve simple to moderate complexity problems in creative and effective ways.
8. Expected to develop and maintain a high level of professional expertise through familiarity with scientific literature. May participate in scientific conferences and contribute to scientific publications.
9. May be involved in new product scale-up, purification, process optimization, technology transfer to manufacturing and process validation activities.

Qualifications

Experience/Educational Requirements

1. Bachelor’s Degree (BS) in life science (Biology, Biochemistry, Microbiology, Chemistry, etc.) or equivalent scientific discipline and 1-3years related laboratory and work experience.
2. A self-motivated individual with prior experience in a manufacture laboratory and protein purification, antibody conjugation, and immunoassays experience preferred. 

Skills and Knowledge Requirements

1. Demonstrate GDP and GMP. Familiarity with QSR and ISO regulations.
2. Ability to take directions from Supervisor and work in a team setting and independently in order to achieve deadlines. 
3. Demonstrate ability to decide how to apply technical knowledge to achieve desired results with guidance from Supervisor.
4. Demonstrate working knowledge of and application of chemistry principles, theories and practices; understanding of scientific basis for work. 
5. Experience developing immunodiagnostic products under Design Controls is a plus.
6. Understanding of immunoassay techniques or equivalent related techniques. 
7. Familiarity with laboratory techniques and equipment of varying complexity.
8. Demonstrate competence in report writing and advanced computer assisted data handling skills.
9. Demonstrate good verbal and written communication skills and ability to present data and findings in a group setting.
10. Demonstrate good interpersonal skills and ability to work as an effective team member, demonstrating tact and cooperation.
11. Ability to solve problems of diverse scope where analysis of situation or data requires an evaluation of identifiable factors.
12. Working knowledge of PC software, Word, Excel and statistics software.
13. Attention to detail.

Physical Demands and Work Environment

1. Laboratory Environment requires the safe handling of chemicals, biohazardous materials and blood borne pathogens.  
2. Must wear appropriate protective gear as directed. Ability safely to operate laboratory equipment.  Ability to type on a keyboard and view a computer screen.