Production Scientist III

Summary of Responsibilities:

MiraVista Diagnostics (MVD) is a clinical reference laboratory with specific focus on fungal pathogen detection in humans and animals. We are seeking a high performing individual with immunoassay manufacturing experience. The Production Scientist will be responsible for formulation of chemical buffers, purifying antibodies, labeling antibodies with detector molecules, assembling IVD/LDT kits and method verification and validation. This individual will lead day to day manufacturing and process validations of products under ISO, CE, and FDA regulations.

Essential Duties and Responsibilities

• Direct resources to complete tasks on time. Assist production as needed to meet throughput requirements.
• Mentor employees by performing supplemental technical guidance and on the job training.
• Help to identify and correct equipment, process, and safety issues in the production laboratory.
• Establish and maintain DMRs, SOPs, Manufacturing Instructions, and other manufacturing documents. Ensure adherence to cGMP, safety policies and company’s procedures.
• Participate on project teams as Technical Lead and Manufacturing representative. And lead Design Transfer activities.
• Develop and execute process verifications and validations.
• Effectively interact with staff in R&D, QA, QC, Regulatory Affairs and Clinical Laboratory departments.
• Understand and support the establishment of purification and analytical methods for characterizing proteins and conjugates.
• Design experiments to problem solve and improve existing manufacturing protocols and QC methods.
• Anticipate potential problems and design preventative solutions.
• Coordinate scientific and investigative studies through collaboration with internal customers, academic research organizations, contract laboratories, and think creatively and provide technical justification for novel concepts and approaches.
• Understand and apply knowledge of a variety of immunoassay manufacturing processes, including protein conjugation, plate and bead coating chemistries, data analysis to develop robust and scalable production processes.
• Be part of team tasked with improvement/development of diagnostic products.
• Equipment function checks and related functional verification with data entry for various pieces of laboratory equipment. Laboratory equipment preventative maintenance tasks.
• Ensure work is aligned with all relevant quality requirements.

Qualifications

Minimum BS in Life Sciences or a related science field; 7 years of Experience in diagnostic industry or 2-5 years with a Master’s Degree is preferred.
• Experience with FDA/GMP regulated medical device manufacturing or similar industry.
• Knowledge of imunnoasay chemistries, IVD product development and manufacturing processes, and equipment validations.
• Proven ability to successfully transfer IVD products from R&D into production.
• Experience in: GMP documents (Master Device Records, Device History Records, SOP’s).
• Experience with electronic QMS and manufacturing ERP systems.
• Good organizational skills.
• Must be able to work productively and independently in an interdisciplinary team environment.

MiraVista Diagnostics is an Equal Opportunity Employer.