Manager, Reagent Manufacturing (Formulation & Packaging)
The Reagent Manufacturing Manager is responsible for the planning, organizing, and set up of a manufacturing environment for production of molecular biology-based commercial reagent kits. In this multi-faceted position, a flexible, organized, and technically competent team leader is highly desirable to support the launch, sustaining manufacturing, and production growth of cutting edge technology products at Pacific Biosciences.
• Manage the day to day activities to direct and coordinate reagent manufacturing and final QC testing activities.
• Review production schedules to address decisions on staff requirements, material requirements, and work procedure requirements, while keeping in mind budget and time limitations
• Review production issues with technical staff to resolve production or QC problems
• Work with Production Planning, Procurement, Materials & Logistics personnel to insure adequate material flow.
• Direct, train, evaluate, and mentor employees to ensure maximum performance and efficiency.
• Set up manufacturing laboratories to increase product consistency, throughput, and scale up liquid formulations and packaging with new equipment and automation.
• Assume a Reagent Quality Assurance role to ensure the integrity of product at the batch record and product release stage.
• Prepare documentation, reports, and standard operating procedures as required
• Short term goals are to deliver product to customers on-time with high quality, high yield, high shelf life, and minimal scrap.
• Long term goals include identifying and completing hands on projects to
o streamline production activities (ex. production time, labor utilization, etc)
o improve scalability of formulations and packaging
o improve manufacturing outputs to workorder
o implement training records/program
o implement equipment maintenance records/program
o tract delivery and productivity activities via metrics.
o identify and communicate technical constraints of manufacturing floor
o document, train and implement standardized operations processes.
• BS/MS in biochemistry/microbiology/molecular biology field
• Minimum 5 years of relevant experience in the pharmaceutical, medical device or Biotechnology industry.
• Minimum 3 years in a management role.
• Experience with production of molecular biology reagent kits
• Experience with reagent tube/plate filling automation
• Experience with cold chain management
• Good mechanical and mathematical abilities and the ability to make critical judgments within the production processes
• Requires excellent communication skills as well as the ability to work well with cross functional teams.
• Computer proficiency- Word, Excel, PowerPoint, MS Project, Visio, ERP, MES
• Familiar with Total Quality Management (TQM), 6 Sigma, cGMPs, ISO13485
• Training in Safety, Operational Excellence, Lean Manufacturing, Leadership
Pacific Biosciences’ mission is to transform the way humankind acquires, processes and interprets data from living systems through the...