Senior Production Chemist

This position works out of our Carlsbad, CA location in the Cardiometabolic and Informatics. Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges.

As the Senior Production Chemist - Mammalian Cell Culture, you’ll have the chance to work with a team of chemists and interact daily with cross-functional departments. This role will be responsible for handling mammalian cells in a GMP manufacturing setting.

• Responsible for the cross training of production chemists.
• Responsible for daily cleaning and maintenance of production equipment – BSC
• Complete maintenance and calibration logs sheets as needed – GDP training
• Production of small-scale biological reagents as directed, following established guidelines and procedures – Assembly, disassembly, and operation of bioreactors/controllers, use of scales, meters and balances, centrifuges, welders, liquid nitrogen storage, and other general use lab equipment.
• Production of small-scale biological reagents as directed, following established guidelines and procedures – Demonstrate the aseptic technique
• Production of small-scale biological reagents as directed, following established guidelines and procedures – Passaging, inoculations, feeds, and harvest filtration
• Operates complex laboratory equipment safely as trained and directed in accordance with established practices.
• Maintain documentation and manufacturing batch records in an accurate, timely, and thorough manner – GDP training, use of ERP systems to transact work orders to batch records,
• Responsible for initiating and completing controlled document changes via the CR/CO process
• Performs MCC processes for bioreactor cell growth (small scale) – Shake flask process
• Responsible for scheduling and maintaining compliance with all lab equipment calibrations and preventative maintenance
• Follow all safety guidelines, manufacturing policies, and procedures.  Operate under strict QSR and ISO compliance.
• Demonstrates commitment to the development, implementation and effectiveness of ARDx Quality Management System per ISO, FDA, and other regulatory agencies.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships
• Carries out duties in compliance with established business policies
• Performs internal documentation and batch record review to ensure accuracy and alignment to GDP practices

• Technical Diploma (± 12 years)
• Minimum 2 years of experience
• Bench laboratory experience in a production lab
• Aseptic Technique
• Pippett
• Ability to work weekends and overtime
• Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR
• Ability to follow detailed instructions, maintain accurate records and notes, and carry out assignments in a thorough, conscientious fashion while adhering to safe laboratory practices
• Strong verbal and written communication skills

• Mammalian Cell Culture experience
• Familiar with general laboratory equipment
• Cell counters
• Incubators experience
• Experience working with excel

In specific locations, the pay range may vary from the range posted.