Technical Lab Service lead Job

Date: Dec 5, 2018

Location: Dublin, IE

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Requisition ID: MAN005800

MSD Biotech Dublin

Are you ready to Invent, Impact, Inspire?

Join MSD and shape the future of healthcare in Ireland

INTRODUCTION

At MSD Ireland, 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.

MSD BIOTECH, DUBLIN

The latest addition to the MSD Ireland family is MSD Biotech, Dublin. The site will play a pivotal role in the manufacture of MSD’s biologics-based medicines, including in the area of immuno-oncology, and will expand MSD’s current internal network of biologics drug substance manufacturing plants when full manufacturing operations begin in 2021.

MSD Biotech Dublin, will be MSD’s first ever Large-Scale Mammalian-Based Drug Substance Facility, with the mission and ambition to manufacture breakthrough medicines from Ireland for patients around the world.

This facility will be a significant supplier of drug substances for one of MSD’s key treatments and will also be critical in the future supply of new biotechnology products to its global network.

& SPECIFIC OBJECTIVES

The QC COE lead is a specialised critically important role within the QC organisation to ensure efficient and effective compliant design, construction, qualification, and operation of the new strategic MSD Drug Substance facility. This tremendous opportunity will be responsible for all instrumentation across all labs, software systems; validation of instrumentation; instrumentation life cycle; instrumentation maintenance and calibration program; the stability program other supporting activities that go across all QC labs. This person will be key in maintaining the lab at a high standard and ensure the process is streamlined and in line with MSD lean methodologies.

POSITION RESPONSIBILITIES



  • The motivation to be an inspiring member of a high performing team.

  • The passion to build the future of MSD biologics.

  • The desire to continuously learn, improve and develop.

  • A great communicator, decisive decision maker and proven ability to deliver excellence.

  • Strong knowledge and experience of validation methodology.

  • Understand the maintenance and calibration program for all of the QC labs.

  • Ensure all QC instrumentation meets the currently requirements and monographs.

  • Has a good working knowledge on IT system and their interactions with lab instrumentation.

  • Ensures data integrity requirements is verified and maintained for the life of the instruments.

  • Strong knowledge on a stability program.

  • Delivery of area performance to meet or exceed performance or quality goals.

  • Ensure compliance with cGMP and other business compliance regulations.

  • Promote and participate the implementation and maintenance of the relevant safety programmes.

  • Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.

  • Participate and Comply with the MSD Quality Management System requirements.

  • Build relationship with IT, site engineering and vendors.


Good understanding on how to build good relationships with key partners, (external vendors etc.

REPORTING STRUCTURE

Reporting to QC lead

Qualifications

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

General
5-7 years industry experience with significant knowledge and experience in laboratory instruments, validation and life cycle.

Technical



  • Validation knowledge

  • Technical knowledge

  • Scientific qualification and relevant experience in pharmaceutical environment

  • Problem solving skills.

  • Leadership skills.


People



  • Ability to respond to changing priorities.

  • Communication skills.


Education



  • Degree qualification (Science/Quality/Technical).

  • Desirable evidence of Continuous Professional Development.

  • Preference Lean Six Sigma


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


 


 


Search Firm Representatives Please Read Carefully:
MSD is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD. No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.



Job: Manuf./Operations Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Oncology, Laboratory, Biotech, Engineer, Lean Six Sigma, Healthcare, Science, Engineering, Management

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