Process Development Scientist

Autonomous Medical Devices Incorporated (AMDI)

Autonomous Medical Devices Incorporated (AMDI) is a California-based company employing a world class team of engineers, scientists, clinicians, manufacturing and quality/regulatory experts dedicated to the development and manufacture of best in class diagnostic devices using innovative technology, factory automation, and cloud connectivity. AMDI is headquartered in Santa Ana, CA where it manufactures the Fast PCR Mini Respiratory Panel in an ISO:13485 / MDSAP certified 110,000 square foot facility.

Are you an innovative, hands‑on scientist with a passion for research and process development? We’re looking for a Scientist I to join our team! In this role, you will take a hands‑on role in synthesizing biomolecular reagents and their implementation in AMDI’s Fast PCR products. The individual will also develop QC processes for reagents, drafting SOPs, and process validation. The successful candidate will have demonstrated an in‑depth understanding of synthesis and purification techniques.

Location: This is an onsite position located at our Santa Ana, CA office. Candidates living within a 25‑mile range preferred.

• Be an expert and execute in the synthesis of oligonucleotides for PCR
• Demonstrate hands‑on capabilities in process development
• Scale up biomolecular reagent manufacturing from bench‑scale to GMP full‑scale manufacturing
• Lead development efforts for implementing new reagents from feasibility through validation
• Collect and document ongoing experiments in electronic lab notebooks and test protocols, summarize data, and present in group meetings
• Write manufacturing procedures and validation protocols in support of reagent qualification/validation
• Effectively manage projects and resources. Interface with quality staff to ensure reliable integration, scale‑up, and documented transition into production
• Follow the lab safety procedures and carry out preventative maintenance of laboratory equipment, as needed
• Work on other scale and manufacturing process development projects as the need arises
• Support manufacturing including formulations laboratory work as needed

• Master’s degree in life sciences or physical sciences (or equivalent) required;
  Ph.D. strongly preferred
• Minimum of 5 years of experience in biomolecular research field
• Minimum of 3 years of combined experience in oligonucleotide synthesis
• Experienced in analytical techniques (HPLC, LC‑MS, ESI‑TOF)
• Motivated team player with attention to detail, a strong desire for collaboration, and accountability; commitment to accomplish team goals, and the ability to prioritize work in a fast‑paced environment are critical
• Excellent organizational skills and ability to plan ahead
• Problem‑solving skills sufficient to identify issues, conduct research, and develop innovative solutions
• Strong written and verbal communication skills especially with technical writing
• Ability to provide presentation to a small or large group audience
• Excellent computer skills in Excel, Word, and Outlook. Prior experience with analytical software, electronic lab notebooks, etc.
• Ability to collaborate with other team members to work on projects
• Minimum of 2 years’ experience in research environment at biotech
• Previous experience in protein synthesis, preferred
• Previous experience in process development, preferred

• Onsite work at Santa Ana facility, possibly travel to Menlo Park location as the need arises
• Requires the use of personal protective equipment to prevent exposure to biohazardous waste and chemicals
• Requires the use of solvents and reagents for oligonucleotide synthesis

The estimated base salary range for this position is $90,000 - $120,000 annually
. If the level of the role changes during the hiring process, the applicable base pay range may be updated accordingly. The actual base salary offered will be determined by several factors, including, but not limited to, the applicant's qualifications for the position, years of relevant experience, distinctive skills, and level of education attained.

• Company provided lunch to…