Production Scientist I, Reagent Manufacturing - BioPathogenix : Job Details

Position Overview

We are seeking a highly organized and detail-oriented Production Scientist I, Reagent Manufacturing to join our team at the Nicholasville, KY manufacturing facility. The successful candidate will be responsible for supporting and executing manufacturing processes, ensuring that all production-related documentation, procedures, and standards are properly implemented and maintained in accordance with Good Manufacturing Practices (GMP) and ISO 13485:2016. This role requires strong technical skills in molecular and cell biology techniques, a comprehensive understanding of production workflows, attention to detail, and the ability to work both independently and collaboratively in a fast-paced setting.

This is an onsite position. No remote or hybrid work allowed.

Key Responsibilities

Manufacturing:

· Manufacture custom products with precision, adhering to established protocols and quality standards.

· Operate and maintain laboratory equipment and liquid handling robots, such as liquid handlers, centrifuges, thermocyclers, spectrometers, etc.

· Perform molecular and microbiology techniques, including qPCR, DNA quantitation, purification, and cloning.

· Package and organize products for shipping in a timely and accurate manner.

· Maintain thorough and accurate documentation of all work performed using provided templates and software applications.

· Update, draft, and revise work instructions and documentation as required.

· Assist with troubleshooting and resolving process deviations to ensure consistent quality.

· Learn and promote lean six sigma manufacturing concepts to optimize workflows and improve efficiency.

· Perform quality control testing on manufactured products to ensure compliance with established specifications and standards.

Compliance and Collaboration:

· Work according to Good Manufacturing Practices (GMP) and ISO 13485:2016 standards to ensure compliance.

· Pay close attention to detail to produce consistent, high-quality work.

· Collaborate effectively with team members and contribute to maintaining a safe and productive work environment.

· Complete daily assigned tasks to meet manufacturing schedules and report progress to Supervisor.

Required Qualifications:

· Bachelor's degree in molecular biology, biochemistry, or a related field.

· Hands-on experience with laboratory equipment and molecular biology techniques in a production environment.

· Proficiency in operating laboratory instruments and automated systems.

· Strong organizational skills with the ability to maintain detailed records.

· Ability to troubleshoot and resolve issues independently while adhering to protocols.

· Self-motivated, proactive, and capable of working with minimal supervision.

· Commitment to quality and attention to detail.

Preferred:

· Familiarity with ISO 13485:2016 standards or equivalent regulatory frameworks.

· Experience working in ISO-certified environments with specific protocols for contamination control.

· Knowledge of lean manufacturing concepts and quality management systems.

· Previous experience in a GMP-compliant production environment.