Associate Director, External Manufacturing Technical Operations

Company: Institute for Credentialing Excellence
Location: West Point
Posted on: April 8, 2021

Job Description:

Institute for Credentialing Excellence (ICE)

• Associate Director, External Manufacturing Technical Operations M Associate Director, External Manufacturing Technical Operations DescriptionJob Description
  
  Are you interested in being an Associate Director of External Manufacturing Technical Operations with our company? Reporting into a Director, Pharmaceutical Technical Operations - External Manufacturing Tech Strategy and Execution, you will be responsible for leading the technical interface with strategic external partners at the Focus Factory level for the Organon CMO platform. This role acts as the technical interface between the company and Organon Contract Manufacturing Organizations (CMOs).
  
  What you will do:
  
  Bring energy, knowledge, innovation and leadership to carry out the following:
  
  • Be the technical point of contact for the CMO and collaborates with other core functions (Quality, Operations, Supply Chain) and also other specialty Centers of Excellence (COE) in the Science & Technology organisation.
  • Technology transfers, Investigations, Process Improvements, Project Management and Change Control.
  • Technical support and resolution of Quality issues such as Deviations and Customer Complaints.
  • Functioning independently and providing coordination, communication, and oversight on all technical matters pertaining to the assigned external partners.
  • Responsibility for the technical aspects of Fact Finding around quality and supply investigations.
  • Together with the Focused Factory Team (Ops, Quality, Tech), establishing a calibrated technical oversight approach based on the capabilities and technical competence of an external partner.
  • Together with the Factory Focused Team, establishing clear expectations, measures and periodic monitoring of operational and quality performance associated with the assigned external partners.
  • Providing technical expert consultation and review on commercial agreements.
  • Participating in Technical due diligence assessments.
  • Assuring site technical readiness for all new product introductions or transfers.
    
    What skills you will need:
    
    In order to excel in this role, you will more than likely have:
    
    • B.S. degree in Engineering, Chemistry or Pharmacy.
    • At least 8 years of hands on pharmaceutical manufacturing experience in the areas of process start up and technical transfer or demonstrated experience in pharmaceutical and packaging operations in general and solid dosage in particular, including quality systems and process technology.
    • Demonstrated deep technical skills in the areas of solid dosage unit operations.
    • In-depth understanding and proven expertise in application of quality systems, especially technical subsystems related to process and equipment qualification, change control, deviation management and cleaning qualification;
    • Advanced understanding of the relevant scientific/ technical concepts to execute routine and increasingly complex tasks; advanced working knowledge in the relevant scientific /technical techniques and is able to apply those techniques to routine and increasingly complex tasks.
    • Technical skills additionally in the areas of liquid, cream/ointment, and packaging operations.
    • Expertise in MPS including Lean Six Sigma green belt level certification, with black belt preferred.
    • Statistical data analysis with Minitab.
      
      Current Employees apply HERE
      
      Current Contingent Workers apply HERE
      
      US and Puerto Rico Residents Only:
      
      Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
      
      For more information about personal rights under Equal Employment Opportunity, visit:
      
      EEOC Poster
      
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      We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
      
      Search Firm Representatives Please Read Carefully
      Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
      
      Employee Status:
      Regular
      
      Relocation:
      No relocation
      
      VISA Sponsorship:
      No
      
      Travel Requirements:
      25%
      
      Flexible Work Arrangements:
      Remote Work
      
      Shift:
      
      Valid Driving License:
      
      Hazardous Material(s):
      
      Number of Openings:
      1
      
      Requisition ID:R106439
      
      Job Information
      • Job ID: 56381796
      • Position Title: Associate Director, External Manufacturing Technical Operations
      • Company Name: Merck & Co., Inc.
      • Job Function: Other
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Keywords: Institute for Credentialing Excellence, Columbus , Associate Director, External Manufacturing Technical Operations, IT / Software / Systems , West Point, Georgia