Autonomous Medical Devices Incorporated (AMDI), with its principal place of business in California, employs a world class team of engineers, scientists, clinicians, and manufacturing experts dedicated to the development and manufacture of point-of-care diagnostic devices using breakthrough microfluidics, protein engineering, and data/cloud connectivity. AMDI will launch its first products from its ISO:13485 certified 110,000 square foot facility in Santa Ana, CA.
Summary of Position We are seeking a highly motivated Associate Scientist to join our dynamic biotech industry team. The Associate Scientist will be part of the Assay Development team and work as part of a collaborative and cross functional effort to conduct Design of Experiments (DOE) and optimization experiments, Verification and Validation studies to assist in the development of novel molecular diagnostic and immunodiagnostic assays. Performance emphasis will be on planning, executing experiments in a BSL2 environment, summarizing and presenting results to complete development activities to support regulatory submission and product launch. They will also assist in developing QC process, drafting manufacturing procedures and implementing process improvement activities.
Location: This is an onsite position located at our Santa Ana, Ca office.
Essential Duties and Responsibilities Draft material specifications, manufacturing procedures, and equipment operating procedures and prepare reagents and solutions as directed, using appropriate documentation methods. Execute experiments and studies as an independent contributor or as part of a team. Design moderately complex to multi-factor experiments with appropriate statistical power. Complete statistical analysis of data and present it in easy-to-understand graphs/figures. Provide written and/or oral updates to the team regarding data, progress, technical issues and troubleshooting efforts. Interface with QC and manufacturing staff to assist in reliable integration, scale up and tech transfer of manufacturing procedures. Participate effectively in developing QC procedures for incoming biologicals and subassemblies. Maintain accurate records of all lab work either in physical or electronic form. Participate in using Quality Management System and uphold AMDI's Quality Policy. Assist with other responsibilities and/or projects as the need arises. Qualifications Required for Position Minimum of a Bachelors Degree in biology, chemistry, Bioengineering, Chemical Engineering or equivalent. Advance degree preferred. Minimum of 2 years' experience in diagnostics industry with experience in protein characterization/assays, reagent formulation and/or assay development. Background in analytical methodologies and statistical analysis is preferred. Experience with Good Laboratory Practices (GLP) and Good Documentation Practice (GDP) preferred. Desired skills and traits Collaborative and motivated team player with a positive attitude and solid work ethic. Sets specific goals and objectives to complete tasks on-time in an organized manner. Effectively communicates in both written and oral presentations on data generated. Excellent attention to detail, record keeping and a passion for accuracy and precision. Ability to work in a fast-paced environment with deadline-driven workflows. Work Environment In-person position that requires working indoors in a BSL2 facility and testing laboratory environment. Requires the use of personal protective equipment to prevent exposure to biohazardous waste and chemicals. Autonomous Medical Device Incorporated offers a comprehensive compensation and benefits package to eligible employees including: Company provided lunch to all employees when working at one of AMDI's on-site locations. 401(k) match. Health insurance, 100% paid for by employer including: Medical, Dental, Vision & Life Insurance. Competitive vacation, sick days & paid holidays. Tuition reimbursement. Casual dress code. Employee discounts on activities such as theme parks, movie theaters, hotels, rental cars, etc. Monthly company-wide socials and activities. Autonomous Medical Devices Incorporated (AMDI) will not accept unsolicited resumes from any source other than directly from a candidate. An Agency must obtain advance written approval from AMDI's internal Human Resources team to submit resumes only in conjunction with approved valid fully executed contracts. Our commitment to an inclusive workplace: We are an equal opportunity employer and encourage people from all backgrounds to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other protected characteristic under federal, state, or local law.
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