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Title

Production Manager - Drug/Device 

About the Organization kaléo is a new type of pharmaceutical company, dedicated to building innovative solutions for serious and life-threatening medical conditions.  
Description

GENERAL DESCRIPTION:

The Manufacturing Manager / Senior Manager is responsible for working with Contract Manufacturing Organizations (CMOs) and kaleo stakeholders to ensure efficient and effective commercial production operations. The Manager / Senior Manager is a proactive partner, driving a science and risk-based, quality compliant manufacturing culture that is flexible and innovative. The Manager / Senior Manager is responsible for CMO process and performance management, CMO finished goods and inventory management, and troubleshooting / resolution of routine operational issues.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Provides leadership for manufacturing and operational activities for commercial production operations in the kaleo Contract Manufacturing Organization (CMO) network
  • Collaboratively manages key projects with CMO project management
  • Coordinates all aspects of manufacturing operations including the oversight of day-to-day operations to ensure timely completion of associated operations/documentation and assist in the monitoring and adherence of cGMP requirements at CMO locations
  • Monitors Manufacturing, Quality Assurance, and Compliance to meet appropriate Regulations to assure timely product delivery.
  • Works with the Production Coordinator and CMO resources for the scheduling of all batches, supply of materials, and direct shipment of bulk and finished product at manufacturing sites.
  • Tracks and monitors Key Process Indicators (KPIs), schedule adherence, and cycle-times
  • Escalates and supports issue resolution with CMO's and other partners to ensure that all issues which may have an adverse effect on the quality of the product are escalated in an appropriate manner
  • Develops solutions for a diverse range of problems that require complex judgements, using highly developed levels of conceptual thought, strategic vision and analysis
 
Open Date 6/8/2017  
Position Requirements

POSITION REQUIREMENTS:

  • A Bachelor’s degree in a science or technical field is required
  • Project Management certification or experience preferred
  • Minimum of 5 years manufacturing operations, supply chain, and/or logistics experience in pharmaceutical or medical devices
  • Advanced training or experience with cGMPs and CFR Title 21 and relevant Guidance(s) for Industry
  • Must be able to obtain feedback from stakeholders and implement improvements

QUALIFICATIONS:

  • Hands-on experience with cGMP and ISO Quality standards with demonstrated success in project management and process improvement initiatives in the development / manufacture of medical devices
  • Experience in collaborating with CMOs
  • Experience in project management and risk management / mitigation
  • Ability to gather, analyze and interpret data to ascertain product and process performance and support investigations when needed
  • Excellent problem solving skills with the ability to deal with ambiguity

  • Ability to create and improve systems, processes, tools, policies, and SOPs to ensure compliance with requisite regulatory, contractual and financial requirements
  • Ability to work within a team to resolve product issues and investigations
  • Ability to build and maintain strong customer relationships
  • Understands and listens to team members and stakeholders needs while supporting productive team environments toward one common objective
  • Proven skills in proactive resolution of technical challenges with tact, diplomacy and composure
  • Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments
  • Strong interpersonal, written and oral communication skills
 
Exempt/Non-Exempt Exempt  
Full-Time/Part-Time Full-Time  
EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.  
Location Corporate  

This position is currently not accepting applications.

To search for an open position, please go to http://KaleoPharma.appone.com



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