Molecular Manufacturing Technologist (1st Shift)

Job Responsibilities

• Follows established laboratory protocols governed by standard operating procedures (SOPs).
• Performs molecular techniques with proficiency: cell culture, control and reagent manufacturing, nucleic acid extraction, quantification and normalization, next generation sequencing (NGS) and other laboratory assignments with consistency and precision.
• Maintains exceptional quality standards for all molecular and manufacturing processes.
• Operates and performs routine troubleshooting on laboratory instruments and accessories used in manufacturing workflows.
• Maintains laboratory equipment, accessories and instruments used in processing by performing routine maintenance.
• Aids in training and mentorship of new and existing manufacturing technologists.
• Prepares Corrective and Preventive Action (CAPA), Quality Event (QE) and/or Deviation (DEV) documents for nonconformance events observed during manufacturing operations.
• Collaborates with the Quality, Product Development, Translational Science, and Regulatory teams to validate or implement new technologies, methods and equipment.
• Proficiency in the Laboratory Information Management (LIMS) tracking system to accurately perform and record day-to-day tasks.
• Represents the department in audits, investigations and cross-functional initiatives.
• Identifies and implements opportunities for continuous improvement, innovation and efficiency.
• Initiates, tracks, and documents continuing education hours.

Required Qualifications

• Bachelor's degree in chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution.
• 3+ years relevant molecular and/or manufacturing experience with at least 1 year being high complexity testing.
• Demonstrates mastery of molecular assay operations and QC systems.
• Experience in FDA regulated industries.
• Proficient in Microsoft Office programs, such as Word, Excel, and Outlook.
• General working knowledge of internet for business use, and skilled in operating office equipment.

Preferred Qualifications

• Master's degree in chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution.
• Experience in ISO 13485 regulated industries.
• Operates with high autonomy and professionalism.
• Techical authority with strong analytical judgement.
• Proactive, solution-oriented and collaborative.
• Mastery of laboratory safety procedures for biohazards and chemicals, as well as quality control procedures and regulations.
• Ability to work in a fast-paced, deadline driven environment.
• Proficient in verbal and written communication skills.
• Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results.
• Commitment to the successful achievement of the team and organizational goals through a desire to participate with and help other members of the team.
• Demonstrate a focus on listening to and understanding client/customer needs.