Specialist, Global Technical Operation- Biologics External Manufacturing Job

Date: Jun 24, 2019

Location: Cork, IE

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Requisition ID: CHE006684

[Specialist, Global Technical Operation- Biologics External Manufacturing] 

[Flexibile within Europe, Brinny Ireland, Luzern Switzerland]

Are you ready to Invent, Impact, Inspire?

Join MSD and shape the future of healthcare in Ireland

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Our Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

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 CARLOW

MSD Brinny is a leading facility for the development, testing and manufacturing of new biologics and vaccines, exporting to over 90 countries across the world. With a team of approximately 500 people, MSD Brinny specialises in the late-stage development and commercial supply of biotech products, including some of the company's most successful and life-changing treatments for oncology, hepatitis C and rheumatoid arthritis.

The Brinny site has been a vibrant part of the local Innishannon community for nearly 35 years and is now one of the region’s largest employers. MSD has invested €130m in the site since 2016 as a result of increased global demand for MSD medicines and vaccines which will see MSD Brinny further expand its production facilities and capacity to meet this demand.

& SPECIFIC OBJECTIVES

The Global Technical Operations Manufacturing support team require a Technical Specialist to join their high performance team in Europe. The successful candidate will assist the site tech ops leads in their responsibilities for the management of the technical interface between MSD and our External Partners (EP) supporting MSD Bulk Biologics and Vaccines Drug substance for commercial and clinical manufacturing operations. Reporting the GTO EU regional lead, the successful applicant will demonstrate high levels of drive, enthusiasm, flexibility and innovation to support the diverse MSD portfolio.


The incumbent needs to have technical knowledge of bulk biologics drug substance unit operations (i.e. cell culture/fermentation and downstream purifications processes). 

Activities will include:
  • Reports to Regional Lead, EU GTO Biologics, and receives general direction on goals and objectives. Works closely with assigned site tech ops lead for day to day responsibilities. 
  • Supports facility start-up and technical transfer to an EP for new products and/or provide global technical operations support for continuous commercial manufacturing at an EP for existing products
  • Collaborates with Biologics External Manufacturing Operations, Biologics Quality Operations and others on the Integrated product team (IPT) to support the product lifecycle 
  • Supports validation strategies for new and existing products.
  • Support internal and external changes to ensure compliant manufacture of products
  • Performs reviews of external partner documents including but not limited to, change controls, batch records, validation studies and technical comminications.
  • Troubleshoot manufacturing issues and support investigations through scientific problem solving approaches
  • Understands regulatory requirements and partners with Operations, Quality, and the EP to develop more efficient ways to meet these requirements. 
  • Based on calibrated oversight model, minimizes duplication of efforts between EP and MSD systems.
  • Partners with EP's to achieve business goals and to establish a common culture that benefits both MSD and EP.
  • Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
  • Actively participates in a culture of continuous improvments and process optimization by deploying MSD Six Sigma tools



Qualifications

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS


Education Minimum Requirement: Qualified candidates must have a minimum BS in chemical/biochemical engineering, pharmaceutical science or chemistry/biology or related disciplines

Required Experience and Skills: Minimum of six months of experience supporting the areas of bulk biologics / vaccines manufacturing, technical transfer , or have demonstrated experience in these areas: process validation, process scale up, process engineering . Must be able to multi-task and work within tight deadlines. This position requires flexibility and the ability to work independently, as well as excellent organizational skills. Strong professional and interpersonal communication skills are also required.

Preferred Experience and Skills: Preferred but not required to have previous experience in External Manufacturing, Change Control Management, Deviation management, Validation and Statistical analysis

Travel will be a requirement of this position at approximately 25% (primarily EU). 

The position is flexible within Europe. The GTO EU biolgics team currently has nodes in Lucerne, Switzerland and Cork, Ireland


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 


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.

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



Job: Chemical Engineering
Other Locations: Luzern, Lucerne, CH; Oss, North Brabant, NL
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Biochemistry, Medical, Oncology, Biotech, Industrial, Science, Healthcare, Manufacturing

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