Associate Director, Sterile API, External Manufacturing Technology
MSD Switzerland
Greece
πριν από 5 μέρες

Description

Are you ready to Invent, Impact, Inspire?

Join MSD and shape the future of healthcare in Ireland

INTRODUCTION

At MSD, we are committed to Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.

THE COMPANY

MSD Ireland is one of the country’s leading healthcare companies, having first established here over 50 years ago.

We currently employ over 1,700 employees, across four sites in Ballydine, Co Tipperary, Brinny, Co Cork, Carlow and Dublin and, in addition, operate substantial Human Health and Animal Health businesses.

In total to date, we have invested $2.5 billion in our Irish operations and our annual turnover ranks us as one of Ireland’s top 20 companies.

Currently, our Irish sites manufacture approximately half of MSD’s top twenty products, saving and enhancing lives in over sixty countries around the world.

With almost 70,000 employees operating in more than 140 countries, you will be joining one of the world’s largest pharmaceutical companies.

JOB DESCRIPTION & SPECIFIC OBJECTIVES

The Chemical Technical Operations (CTO) organization is seeking a highly motivated individual to fill a new position to support the manufacture of sterile and non-

sterile drug substances and intermediates.

This role can be based at any of our sites in the EU.

The position is a technical leadership role, reporting to the Director, Chemical Technical Operations, External Manufacturing API Technology.

The technical lead will provide process support to External Partners (EP) in our External Manufacturing (ExM) Focus Factory to resolve production issues, evaluate and manage process change requests, proactively assess and manage process / technical risks, and provide guidance on process improvement and capacity optimization.

This individual will be expected to provide leadership and technical solutions to complex technical problems and projects, have strong influencing skills and the ability to excel working on cross-

functional, cross-company, global teams.

Responsibilities include :

  • Functions independently with minimal oversight
  • Collaborates with Focus Factory team members (eg. Operations and Quality) and others to facilitate supply of products from EP’s with an End-to-End mindset.
  • Coordinates with impacted (downstream and upstream) MSD sites and EP’s.
  • Maintains strong technical connectivity with our Sterile Network and represents the small molecule API Platform technical team as the point of contact to the Sterile Network.
  • Builds technical capability in the Focused Factory team in aseptic processing and sterile operrations.
  • Initiate and drive change controls to completion
  • Provide technical transfers and validation support as well as development of plans to meet capacity needs.
  • Provides rapid responsive support to EPs to resolve manufacturing issues and minimize supply disruptions.
  • Proactive partnership with EP's to achieve business goals, mitigate risks and continuously improve performance so as to establish a common culture that benefits both us and our EP
  • Demonstrates consistently a strong compliance and EHS mindset in driving excellence in supply performance in the Focused Factory, ensuring inspection readiness at all times.
  • Partners effectively and leads the interface with our Research Laboratories (Process Chemistry, Chemical Engineering R&D, Analytical R&D), as well as our other Science and Technology groups (Supply Analytical Sciences, Center for Mathematical Sciences, Material Sciences etc.
  • on aligned priorities.

  • Executes technical due diligence assessments at potential EP’s.
  • Provides expert consultation and review of small molecule manufacturing technical matters.
  • Provides a 'calibrated' technical review of EP process change requests and deviation reports.
  • Understands the true regulatory requirements and partners with Operations, Quality, Regulatory and the EP in applying efficient ways to meet these requirements.
  • Qualifications

    QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

  • BS / MS / Ph.D in in chemical / biochemical engineering, pharmaceutical science or chemistry or related fields
  • Minimum of 7 years of post-BS experience, including manufacturing experience in the areas of API process production, with demonstrated experience in process start up, process optimization, and technical transfer.
  • Three (3) or more years of experience with sterile / aseptic processing.

  • Experience in biological manufacturing including fermentation, chromatography, and downstream purification is a plus.
  • Experience in leading technical teams in the areas of process development / commercialization / tech transfer / supply of API products
  • Flexibility and the ability to work independently, with excellent organizational skills.
  • Strong Leadership Behavior attributes including a global mindset, an end to end supply chain view, ability to collaborate across functions and geographies and multi-
  • task effectively, strong interpersonal and communication skills, ability to establish and maintain strong working relationships with technical, quality and operations leaders in the internal and external network

    Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

    At MSD, we’re inventing for life.

    So, if you are ready to :

    INVENT solutions to meet unmet healthcare needs

    IMPACT the future by joining MSD, one of the world’s leading healthcare companies

    INSPIRE your team to reach their full potential and push the boundaries of science and technology

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