ColumbusGARecruiter Since 2001
the smart solution for Columbus jobs

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

        EEOC GINA Supplement

        OFCCP EEO Supplement

        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:

        No relocation

        VISA Sponsorship:

        Travel Requirements:

        Flexible Work Arrangements:
        Remote Work


        Valid Driving License:

        Hazardous Material(s):

        Number of Openings:

        Requisition ID:R106439

        Job Information
        • Job ID: 56381796
        • Position Title: Associate Director, External Manufacturing Technical Operations
        • Company Name: Merck & Co., Inc.
        • Job Function: Other
        • Job Type: Full-Time Jobs You May Like M Merck & Co., Inc. West Point, PA, United States M Merck & Co., Inc. West Point, PA, United States M IACUC Post-Approval Monitoring Senior Specialist Merck & Co., Inc. West Point, PA, United States IACUC Post-Approval Monitoring Senior Specialist 2025 M Street, NW, Suite 800 Washington, Dist. Columbia 20036 (202) 367-1165

Keywords: Institute for Credentialing Excellence, Columbus , Associate Director, External Manufacturing Technical Operations, IT / Software / Systems , West Point, Georgia

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other IT / Software / Systems Jobs

Software Test Engineer II
Description: The Software Test Engineer is responsible for developing automated testing strategies and implementing them in industry standard testing frameworks. The Software Test Engineer provides testing automated (more...)
Company: Cox Enterprises
Location: Atlanta
Posted on: 04/16/2021

Front End Software Developer
Description: Over the next few years, CRST The Transportation Solution will be implementing significant enterprise wide system and software upgrades. In support of this project, and of future needs, we are expanding (more...)
Company: CRST Expedited
Location: Atlanta
Posted on: 04/16/2021

Telecommunications Technician
Description: It's your turn to take the lead and deliver the future before anyone else. You'll introduce our customers to AT T's award-winning TV service and state of the art technology while creating a best in class (more...)
Company: AT&T
Location: Kennesaw
Posted on: 04/16/2021

Virtual Senior Java Developer
Description: A global clothing retailer has an open position for a Virtual Senior Java Developer.
Company: VirtualVocations
Location: Decatur
Posted on: 04/16/2021

Sr.Software Developer
Description: Job Description:We have an immediate need to hire multiple Software Engineers. Somebody with more than 5 years of experience as Full Stack Developers. Attending video interview on (more...)
Company: iQuadra Information Services LLC.,
Location: Atlanta
Posted on: 04/16/2021

Full Stack React Developer
Description: Are you a problem solver who wants to work with clients to figure out what lies behind the financial numbers Are you interested in identifying key business issues to drive meaningful change If so, Deloitte (more...)
Company: Deloitte
Location: Atlanta
Posted on: 04/16/2021

Senior .Net Developer
Description: Senior .Net Developer100 Remote6 Month Contract-to-Hire br The Senior .Net Developer is a vital player in the Emmy award winning application team. We are looking for someone who has thorough professional (more...)
Company: Brooksource
Location: Atlanta
Posted on: 04/16/2021

Remote Technical Support Specialist II
Description: A telecommunications company is filling a position for a Remote Technical Support Specialist II. Core Responsibilities
Company: VirtualVocations
Location: Atlanta
Posted on: 04/16/2021

Technical Implementation Support Specialist (Remote)
Description: Technical Implementation Support Specialist Remote br Reporting to a customer success manager, you will be responsible to ensure that all the customers allocated to you have successful overnight updates (more...)
Location: Atlanta
Posted on: 04/16/2021

Salesforce Technical Architect
Description: OverviewGuidehouse is a leading management consulting firm serving the public and commercial markets. We help our clients solve complex challenges and guide them to a future that builds trust in society. (more...)
Company: Guidehouse
Location: Atlanta
Posted on: 04/16/2021

Log In or Create An Account

Get the latest Georgia jobs by following @recnetGA on Twitter!

Columbus RSS job feeds