Manufacturing Director

Gator Bio, the leading developer, and manufacturer of Next Generation Bio-Layer Interferometry (BLI) biosensor technology and services utilized by life science researchers within the biopharma, drug discovery, pharmaceuticals and biotherapeutics. Headquartered in Palo Alto, CA, we provide BLI label-free solutions involving instrumentation, software, and consumables utilized for measuring real-time biomolecular interactions. General applications include quantitation, kinetic analysis, and epitope binning.

Gator Bio is looking for a Manufacturing Director to lead instrument and consumables production. The Manufacturing Directory will oversee our manufacturing team, production plans, laboratory operations, and vendor and supply chain management.

Essential Duties And Responsibilities

• Initiate, plan, and transfer global instrument manufacturing to US domestic operations
• Responsible for the development and implementation of the manufacturing engineering strategy and programs
• Build and scale the California production site to manufacture multiple models of instruments and other devices
• Facility management to meet production needs
• Oversee production of optical biosensors and reagents
• Manage instrument, biosensor, and biochemistry production teams and operations personnel
• Schedule and adhere to monthly, quarterly and annually production targets for internal and external clients
• Track production and quality metrics.
• Anticipate risks and builds contingencies to mitigate negative impact
• Collaborate with internal stakeholders (including Research & Development and Quality) for performance and process improvement and sustainability
• Collaborate with external stakeholders, contractors, and vendors (including regulatory and audit teams) as directed.
• Ensures the highest quality of process operations and manufacturing.
• Reviews and approves validation documents in support of manufacturing processes.
• Align production plans with commercial demand and manage supply and material inventory
• Participate in business development activities including vendor selection and project budgeting to deliver strong business results.
• Lead innovation and continuous improvement efforts to scale capacity and drive efficiency in Operations.
• Work and plan cross-functionally with the global manufacturing and R&D teams
• Additional responsibilities as needed.
  
  
  

Qualifications

• Minimum 10 years’ experience in managing laboratory instrument, opto-mechanical equipment or medical device manufacturing
• Direct experience running a small-scale manufacturing site is preferred
• Exposure to working with optical, mechanical, electronic, motion-control systems is highly desired.
• Proven experience with vendor management and supply chain logistics.
• Prior background as a hardware engineer, mechanical engineer, or electrical engineer is preferred
• Understanding and familiar with quality systems
• Experience in facility management
• Experience working in a life science company is desirable
• Experience in reagent manufacturing is a plus
• Experience working in a multi-cultural and multi-time-zone environment
• Excellent interpersonal and verbal communications skills
• B.S. in engineering, electrical engineering, mechanical engineering, or related subjects
• Experience using tools such as NetSuite and QT9
• Proficient in Microsoft Office Suite: Word, Excel, PowerPoint, etc.
  
  
  

Position Requirements

• To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Ability to lift, push, pull carry, and/or move up to 20 lbs
• This role will require long periods of standing, walking, and sitting.
• International and domestic travels are required
• The employee will be required to use hands for computer work, wet lab and engineering assembly
• Must pass a health screening
• Required biosafety training upon hiring