JOB SUMMARY:
The Senior Manufacturing Associate will take part in the manufacturing of high-quality medical diagnostics products, supervising the production and QC processes at Nucleix. He/she will ensure efficient production cycles and stock availability and drive independent projects related to manufacturing. In addition, he/she will conduct laboratory experiments using samples derived from human biofluids, innovate to create novel protocols, troubleshoot new and existing workflows, maintain accurate records, and communicate findings.
The Senior Manufacturing Associate will report to the Product Development and Operations Manager or higher within the PD department.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Support the production and QC efforts at Nucleix and Nucleix’s CMO.
· Supervise production cycles and ensure that the manufacturing is performed according to approved procedures
· Responsible for detection of deviations and reporting them correctly in a timely manner
· Initiate manufacturing cycles according to forecasts.
· Maintain constant availability of raw materials and final product stocks for customers and internal use.
· Assist in the development of production and QC protocols, including preparation of production/ QC materials, controls, and performance of
lot validations.
· Design and perform experiments, collect data, analyze results, and derive conclusions.
· Independently plan and initiate follow-up experiments.
· Prepare technical reports, SOPs, detailed protocols, and contribute to company documentation as requested.
· Perform routine laboratory operations, including ordering, equipment maintenance, sample management, etc. as needed.
· Collect and process clinical specimens (such as urine, blood, saliva, tumor samples) and cell lines.
· Provide technical support and troubleshooting to other personnel.
· Ensure compliance with Company’s Quality Management System and support quality initiatives to maintain an environment of
continuous improvement throughout the organization.
· Perform other related duties, as assigned
KNOWLEDGE/SKILLS/ABILITIES REQUIRED:
· Ability to work and multi-task in a fast-paced startup environment with a high degree of self-motivation and organization
· Ability to take on responsibility and move things forward, with a can-do approach and in an independent manner
· Familiar with production and QC processes, preferable in the diagnostics / medical devices industries
· Attention to details and ability to follow and understand procedures/workflows
· Problem solving-oriented and critical thinking
· Ability to work with computer/ electronic QMS system
· Hands-on experience in molecular biology laboratory practices
· Demonstrated knowledge, understanding, and ability to apply principles, concepts, practices, and standards of assay development and
analytical methods validation and sample testing in a molecular diagnostics laboratory
· Handle and process of human clinical specimens
· Excellent verbal, written, and interpersonal communication skills (also in English)
· Team player
EDUCATION AND EXPERIENCE REQUIRED:
· Bachelors (5+ years experience ) or Masters (3+ years experience) degree in Biology, Molecular Biology, Biochemistry, Genetics, or a related
field
· 1+ years experience with production, manufacturing, and QC processes
· Experience with standard molecular biology techniques, particularly qPCR, is required
· Previous experience in cell culture work (preferred)
· Familiar with product development lifecycle (preferred)
· Experience developing molecular diagnostic assays (preferred)
· Previous work handling and processing clinical samples (Blood/Urine/Saliva)
