BioFire Diagnostics, LLC. is seeking a Technical Team Lead to join our team that manufactures Oligonucleotides and LCGreen. Technical Team Leads are responsible for providing technical expertise as it pertains to the manufacture of Oligonucleotides. This includes troubleshooting oligonucleotide production processes and being a resource with technical knowledge to the BioReagents project team for process improvements.
PLEASE NOTE: The working schedule for this position will be Tuesday + Every Other Wednesday - Saturday 6:00 AM - 6:00 PM.
Principal Job Duties and Responsibilities:
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
- Participate in strategic planning and resource management to assure optimum utilization of personnel and material resources in order to meet or exceed production, team, individual, and business objectives.
- Responsible for assisting Team Leads with technical issues such as in-process testing, training, organization workflow, and troubleshooting production issues.
- Assist with technical support issues such as manufacturing specialized orders and performing auxiliary testing.
- Provide support to the team to help ensure on time delivery of products.
- Assists as directed with resolving process/product related issues using tools such as Temporary Deviations, rework procedures, NCR’s, etc.
- Maintain records in compliance with regulatory requirements, Good Manufacturing Practices, and Standard Operating Procedures.
- May assist with quality investigations including problem identification and corrective action.
- Work closely with Operations management to identify and implement improvements to manufacturing processes. This includes working within the quality system to improve processes, change documentation, write/perform validations, etc.
- Communicates effectively with supervisors, managers and teams they support.
- Stays current on all manufacturing processes and may perform the job duties of a Manufacturing Team Lead & Trainer as deemed necessary.
- Coordinate efforts with the BioReagents project team to ensure the necessary technical expertise and input is provided on all BioChemistry related projects.
- Other duties as assigned
Strong pipetting skills, attention to detail, organization, and familiarity with cGMP are required.Experience
A minimum of 2 years related experience in an oligonucleotide laboratory, or five years of general laboratory experience.
Preferred: A minimum 1 year experience with: liquid handling platforms, UPLC/MS, HPLC, cGMP/QSR/ISOEducation
Minimum of a Bachelor’s degree in Life Science or Chemistry.Physical Requirements
Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR).