Manager, Reagent Manufacturing (Formulation & Packaging)

Organization: 
Pacific Biosciences
Job Location: 
Menlo Park, CA
Job Description: 

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.

Responsibilities:
• 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.

Requirements: 

• 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

About Our Organization: 

Pacific Biosciences’ mission is to transform the way humankind acquires, processes and interprets data from living systems through the design, development and commercialization of innovative tools for biological research. The company has developed a novel approach to studying the synthesis and regulation of DNA, RNA and protein. Combining recent advances in nanofabrication, biochemistry, molecular biology, surface chemistry and optics, Pacific Biosciences has created a powerful technology platform called single molecule, real-time, or SMRT™, technology. SMRT technology enables real-time analysis of biomolecules with single molecule resolution, which has the potential to transform the understanding of biological systems by providing a window into these systems that has not previously been open for scientific study.