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Sr. Manager or Director of Aseptic Manufacturing

Hours : Full Time
Travel : No
Relocation : No

Job Description :

Our Client is looking for either a Sr Manager or Director of Manufacturing for Aseptic Filling who will be overseeing all manufacturing activities ensuring products are manufactured according to regulation, policies and standards. 


 


Ideal candidate is one who is a manufacturing/industrial engineer or an engineer who has experience with mechanical/automated machines that has experience managing people as well as processes.



  • Manager role – min 5 years’ experience with formulation and filling experience

  • Or Director level role - min 6-8 years’ experience with formulation, filling, packaging, managing multi-functions)


 

 

Do you have a technical understanding of Aseptic? 


Are you a Leader with Vision to drive change and create a plan to implement?


 


Connect with us to learn more on how you can be a member of this amazing opportunity.


 


Essential Job Functions, but not limited to:



  • Direct Formulation, Filtration and Filling production area manufacturing activities - scheduling staff/equipment to master schedule needs - maintaining trained staff,  - driving improvements - budgeting responsibilities



  • Hire, train, mentor personnel - define individual development plans - complete timely performance evaluations 

  • Define resource roles, needs and hiring plan to meet growth objectives - hold team accountable for schedule

  • Strong collaboration/communication across teams and other functional areas.

  • Responsible for change control and regulatory requirements for manufacturing process documentation

  • Identify and implement process improvements

  • Successfully attain budget/business objectives

  • Comply with the corporate policies and procedures.

  • Comply with regulatory and industry standards




 


 


 


Required Qualifications :


  • Bachelors of Science Degree - Engineering, Science or Business.  Equivalent experience may be acceptable

  • 5 + years manufacturing experience (pharmaceutical/medical device preferred)

  • Min 5 years supervisory experience

  • Knowledge and understanding of medical and/or pharmaceutical (drug product) formulation, sterile filtration, and aseptic filling

  • Knowledge of Good Manufacturing Practices for drug and device manufacturing

  • Participate in regulatory site inspections

  • Excellent technical writing skills - Protocols, Operating Procedures, Preventative Maintenance Procedures

  • Previous experience with clean room operations and control (viable and non-viable)

  • Experience with RABS (Restricted Access Barrier) leadership

  • Experience with Grade 5/Class 100

  • Strong communication skills

  • Collaborative Team Player with team and management


 
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