Manager/Director, Reagent Manufacturing - Tuscon, AZ | Biospace
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Manager/Director, Reagent Manufacturing

HTG Molecular Diagnostics

Location:
Tuscon, AZ
Posted Date:
6/12/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Director, Manager, Manufacturing,

Job Description


Essential Duties

•   Manage all aspects of reagent manufacturing for HTG reagents brought to market
         o   Drive high levels of product quality and yield through manufacturing
         o   Ensure high levels of Customer Satisfaction in external Quality metrics and On Time Delivery
•   Determine requirements for the value stream
         o   Establish Supply chain related specifications, yield and quality
         o   Establish capacity plan for internal or contract manufacturing of reagents to meet demand
         o   Effectively manage working capital through pull replenishment
•   Impact entire life-cycle of reagents
         o   Development programs
         o   Transfer to manufacturing
         o   Validation of processes
         o   Scale up to commercialization
         o   Sustain technical revisions
•   Effective execution in an FDA IVD compliant facility and supply chain
•   Support technical needs of product line either directly or through delegates
•   Continuously improve the GMP manufacturing environment
•   Responsible for creating required documents such as SOPs, reagent manufacturing work instructions, incoming material specifications and performance verifications
•   Analyze procedures and production methods to improve quality, cost and productivity while keeping within product specifications, good manufacturing practices, Federal safety regulations and HTG policies.
•   Assures compliance with the HTG quality system
•   Resolves issues related to non-compliance and corrective and preventative actions
•   Monitors own work to ensure high quality product and accuracy
•   Supervises maintenance of accurate and updated documentation
•   Responsible for Reagent Customer Communication life-cycle

Requirements


•   Bachelor’s Degree in Molecular Biology, Chemistry, Biochemistry, or similar technical field
•   6-10 years industrial or independent relevant experience in biotechnology and development of biotechnology products
•   Demonstrated ability to manage complex projects and timelines and meet deadlines
•   Successful track record showing technical proficiency, problem solving and troubleshooting
•   Supervision of a group or operation
•   Experience with late stage process development and commercialization
•   Experience with cGMP and other quality systems
•   Knowledge of product development, manufacturing, handling and control
•   Knowledge of validation concepts for equipment, processes, methods, and products
•   Knowledge of regulatory requirements such as FDA, GMP, GLP, ISO 13485
•   Knowledge or Lean and / or Six Sigma manufacturing principles and techniques
•   Excellent written and oral communication skills, including technical writing
•   Excellent teamwork across functional groups
•   Excellent leadership abilities
•   Ability to contribute novel ideas to solve problems
•   Ability to independently carry out objectives
•   Ability to multi-task, manage time and meet deadlines
•   Ability to accurately determine resource requirements, including time, space, and manpower