Job Description

Description

Position Overview:

The Technical Lead will join Accelerate Diagnostics’ operations department as a member of the consumable manufacturing team.  This individual will be part of a team that manufactures reagents, participates in fill operations, and tests product in support of consumable production on a daily basis.  This person will perform the following tasks without supervision:

• Formulation and aliquoting of reagents, per aseptic manufacturing techniques
• Instrument builds (fill equipment preparation)
• Participation in GMP aseptic filling operations and other manufacturing processes
• Line clearance and closeout responsibilities
• Cleaning/recovery of classified area and workspaces, components preparation
• Final issuance of raw material via QAD/Eagle
• Good Documentation Practices (GDP)
• Labeling and packaging
• Lot yield verification
• Maintaining, operating, and performing minor/basic troubleshooting, for various lab equipment including pH meters, refractometers, autoclaves, automated fillers and analytical balances
• Reporting process or equipment problems to CM team lead
• Inventory movement (stock laboratory/prep raw materials), and cycle counting of inventory
• Familiarity with Lean concepts (5S, Kanban, Kaizen) Equipment maintenance, calibrations and preventive maintenance (PM’s)
• Training and mentoring team members to the above tasks
• Cross Train in different functions in Operations (Kit Assembly, Instruments etc.)
• MWI/document modifications (redlines)
• In-process quality control (QC) testing
• Execution of installation/operation/performance qualifications (IOPQ’s)
• Subject Matter Expert (SME) for each formulation process
• Acting as an independent Project Lead for at least one improvement project
• Acting as a point-of-contact for investigations
• Leading and facilitating daily activities of formulation associates, scheduling additional work/tasks
• Collaborate with CM team lead on additional tasks/responsibilities for formulation team
• Performing batch record reviews and logbook reviews
• Compliance with all company policies & procedures, including proper disposal of chemical waste
• Performing all other duties as assigned by supervisor/management

Qualifications

Qualifications:

• Bachelor of Science Degree in Chemistry or equivalent. Other scientific degrees and/or work experience will be considered.

• Minimum of 6 years’ experience with reagent formulating operations, per manufacturing work instructions and Good Documentation Practices (GDP) in a cGMP environment
• Academic and/or industrial laboratory research experience
• Accurate and precise measurement skills (gravimetric and volumetric)
• Accurate dilution manufacture techniques
• Aseptic technique
• Knowledge of chemical/reagent formulation processes
• Knowledge of wet/bench chemistry
• Excellent written/verbal communication skills
• Organized, meticulous, diligent

The ideal candidate will be a dependable team player with reliable attendance, passion, great communication skills, a sense of urgency to resolve issues as they arise, and an ability to keep up with key daily tasks in a fast -paced environment.