Upstream/Downstream – Shift Technical Lead Job

Date: Dec 23, 2018

Location: Dublin, IE

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Requisition ID: MAN005697


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 Shift Technical Lead will provide technical expertise to the manufacturing shift team in support of the commercial scale manufacturing of recombinant proteins.
You will ensure on-going optimization of the process and provide manufacturing support to ensure the continued manufacture and supply of quality biologic products in meeting our Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan.

As a Shift Technical Lead, you will work with the manufacturing shift team to ensure the effective and efficient on-time delivery of batch production. This requires the delivery of process excellence and reliability across all areas of the manufacturing process.

Reporting to the Manufacturing Shift Lead, the Shift Technical Lead will support operational readiness during start-up and provide operations input to ensure the facility design meets end user requirements. Post start-up, the Technical Lead will support the manufacturing team to consistently deliver on specific Key Performance Indicators (KPIs), e.g. EHS metrics, Production Plan, right first-time execution, compliance and team training.

POSITION RESPONSIBILITIES



  • A key player on the operations readiness team during start up, interfacing with the project to ensure the manufacturing facility will operate as per the user requirements.

  • Provide operations input/support to the design, commissioning and qualification of the new manufacturing facility at MSD Biotech Dublin through to commercialisation.

  • Provide technical expertise in establishing the commercial process and routine manufacturing operations by serving as a commercial manufacturing process subject matter expert.

  • Create and sustain a culture of right first time in in safety, quality and continuous improvement through a focus on principles of lean including simplification, standard work, visual management and learning development.

  • Provide technical expertise for the manufacture of bulk drug substance in a cGMP regulatory environment.

  • Ensure highest Quality & Compliance standards.

  • Subject matter expert for trouble shooting process issues during start-up, tech transfer activities and commercial operations.

  • Responsible for driving a culture of Continuous Improvement by deploying MSD Six Sigma tools within the IPT on projects such as: problem solving, reducing cycle time, lean principles within the process.

  • Coaches manufacturing personnel to increase technical knowledge of critical process steps on the floor.

  • Write, review, and/or approve manufacturing documentation (SOPs, Manufacturing Records & Logbooks) ensuring it is current, accurate and in accordance with regulatory requirements.

  • Leads complex process investigations on the production floor is support of deviation resolution.

  • Provide ongoing coaching and support to cross functional team members, to share manufacturing best practices.

  • Track and trend relevant technical and business process metrics to ensure operations are performing effectively and efficiently.

  • Ensure the effective use of material, equipment and personnel in producing quality products.

  • Participates in safety, process and environmental investigations. Reviews alert and action limits as needed and implements corrective action as appropriate.



REPORTING STRUCTURE

The Shift Technical lead reports to the Manufacturing Shift Lead

Qualifications


QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

General



  • A minimum of 5 years’ experience in a large-scale biologics manufacturing facility.

  • Thorough knowledge of current Good Manufacturing Practices (cGMP).

  • Excellent focus and attention to detail.


Technical



  • Previous experience in a highly regulated manufacturing environment in a technical or manufacturing support role.

  • In-depth working knowledge of manufacturing operations.

  • Demonstrated problem solving capabilities.


People



  • Demonstrated ability to work independently and as part of a cross functional collaborative team to achieve mutual goals.

  • Excellent communication, decision making, people influencing and project management skills.


Education



  • Third level qualification in a Science or Engineering related subject.

 


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


 



*HJFeatured
*HJDublin



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


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