Bio Technician Research & Development

Diazyme Laboratories, Inc.; Poway (CA); On-site; USD 45,000 - 67,000; Full time

Job summary

Diazyme Laboratories, Inc. in Poway, CA is a cGMP and ISO 13485 certified medical device manufacturer.

Under general supervision, this position supports development activities for clinical diagnostic products, working with an interdisciplinary team and maintaining Design History Files. The role involves preparing buffers, running experiments, analyzing data, assisting with GMP and regulatory documents, and supporting scale manufacturing while ensuring product specifications are met.

Qualifications

• Associate’s degree in related discipline with 1+ year in biology/microbiology lab.
• Bachelor’s degree in related discipline preferred.
• Understanding of biological/microbiological principles and lab safety.
• Ability to interpret data and solve moderately complex problems.
• Strong verbal and written communication; maintain confidentiality.

Responsibilities

• Perform life sciences research and development experiments.
• Prepare buffers, stock solutions and operate lab equipment.
• Analyze data and design experiments.
• Maintain project records and present findings.
• Assist with GMP, safety and regulatory documents.
• Support scale manufacturing and ensure specifications.

Skills

Interpersonal communication

Verbal and written communication

Data interpretation

Confidentiality

Teamwork

Flexibility / extended hours

Education

Associate's degree in related discipline

Bachelor’s degree in related discipline

Job description

Job Summary
Diazyme Laboratories, Inc. (www.diazyme.com), is a cGMP and ISO 13485 certified medical device manufacturer. Diazyme uses its proprietary enzyme and immunoassay technologies to develop diagnostic reagents which can be used on most automated chemistry analyzers in user-friendly formats. Products include test kits for diagnosis of cardiovascular disease, liver disease, cancer markers, renal disease, diabetes, sepsis and electrolytes.

Job Summary
Diazyme Laboratories, Inc. (www.diazyme.com), is a cGMP and ISO 13485 certified medical device manufacturer. Diazyme uses its proprietary enzyme and immunoassay technologies to develop diagnostic reagents which can be used on most automated chemistry analyzers in user-friendly formats. Products include test kits for diagnosis of cardiovascular disease, liver disease, cancer markers, renal disease, diabetes, sepsis and electrolytes.
Under general supervision, this position is responsible for the operations necessary to support development activities for clinical diagnostic products. The individual works with an interdisciplinary team, maintains project notes and Design History Files, and presents updates to the Research and Development team and management. Additionally, the role involves participating in the development of standard operating procedures for the project and conducting laboratory experiments in a safe and regulated manner.
DUTIES AND RESPONSIBILITIES:

• Participates in an interdisciplinary team performing life sciences research and development experiments in the laboratory.
• Prepares buffers, stock solutions and operates laboratory equipment needed for research and development.
• Analyzes experimental data and participates in design of experiments to be performed in the laboratory
• Maintains and updates a variety of confidential and sensitive electronic and/or hard copy project records and/or files.
• Presents findings during research and development meetings.
• Completes and submits various good manufacturing practices (GMP), safety, and regulatory related documents as required.
• Assists with scale manufacturing of developed products with testing to assure that product specifications are met.
• Maintains strict confidentiality of sensitive information.
• Other duties as assigned or required.
• Responsible for observing all laws, regulations, and other applicable obligations wherever and whenever business is conducted on behalf of the Company.
• Expected to work in a safe manner in accordance with established operating procedures and practices.
  

We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply.
Job Qualifications

• Typically requires an associate's degree in related discipline and one or more years of related experience working in an academic or industrial biology or microbiology laboratory. Equivalent professional experience in an academic or industrial biology or microbiology laboratory may be substituted in lieu of education.
• Bachelor’s degree in a related discipline is preferred
• Requires a general understanding of biological/microbiological theories and principles as well as a working knowledge of laboratory protocols, and regulatory and safety requirements.
• The ability to interpret data and identify and analyze issues, contributing solutions to moderately complex problems.
• Good interpersonal, verbal and written communication skills to explain general to mid-level information and effectively communicate with all levels of employees.
• The ability to maintain the confidentiality of sensitive information.
• The ability to use basic office/scientific software and knowledge of basic computer operations and applications.
• Ability to work both independently and in a team environment is essential as is the ability to work extended hours as required.
  

Job Type: Full-Time Hourly
Salary range: 45,000 - 67,125