Senior Specialist, GTO Biologics Job

Date: Jul 12, 2019

Location: Brinny, IE

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Requisition ID: CHE006672

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.

Senior Specialist GTO Biologics
 
MSD Brinny
 
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 BRINNY
 

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.


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.


& SPECIFIC OBJECTIVES

The Global Technical Operations Manufacturing support team require a Senior Specialist to join their high performance team in Europe. The successful candidate will provide technical support for 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.

 

In this role, the successful candidate will provide technical support for MSDs drug substance external manufacturing network and will provide technical oversight and support for technology transfers, clinical and commercial manufacturing operations. The candidate will form part of technology transfer (TT) and intergrated Process teams (IPTs) which support the technology transfer and commercial manufacturing of drug substance. Key elements of this role include supporting team/partner interactions, supporting change management, deviations/investigations, and supporting continuous improvement initiatives. While the role will involve primarily working remotely from an MSD site or office in Europe, the ideal candidate is required to be available to travel to sites within Europe and/or North America to effectively manage internal and external partnerships. Additionally, the successful candidate should demonstrate excellent communication skills that are required to manage multiple different stakeholders.

 
 
 
 
The ideal candidate should

>3 years’ experience in similar Upstream/Downstream Technical Support role in Microbial or Cell culture and/or purification manufacturing

MSc Degree in Biochemistry, Microbiology, Engineering or a related field (PhD Preferable). Candidates with a bachelor’s degree in a relevant field with suitable experience will also be considered

Evidence of Continuous Professional Development and cross skilling

 
 
 
POSITION RESPONSIBILITIES
 
Activities will include:

  • Reports to Regional Lead, EU GTO Biologics, and receives general direction on goals and objectives. Functions independently and provides coordination, communication, and oversight of assigned External Partner technical issues.
  • Supports facility start-up and technology transfers, provides on-going support to External Partners to resolve manufacturing issues, and develops plans to meet capacity needs. 
  • Collaborates with Opertions, Quality, Regulatory, Analytical and Process Development teams to ensure project timelines and goals are achieved. 
  • Supports the development of validation strategies for new and existing products.
  • Manages specific subteams within a project, leading and driving crossfunctional meetings
  • Provides a point of technical contact to assigned EP's, impacted our manufacturing division sites and Commercialization. 
  • Management of internal and external changes to ensure compliant manufacture of products
  • Performs reviews and approvals of external partner documents including but not limited to, change controls, batch records, validation studies and technical comminications.
  • Provides a 'calibrated' technical review of EP process change requests, atypicals, and Master Batch Record changes.
  • 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

 

+3 years’ experience in similar Upstream/Downstream Technical Support role in Microbial or Cell culture, purification or vaccine manufacturing. MSc Degree in Biochemistry, Microbiology, Engineering or a related field (PhD Preferable). Candidates with a bachelor’s degree in a relevant field with suitable experience will also be considered. Evidence of Continuous Professional Development and cross skilling. 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.

 

  • Additionally, experience in one or more of the following areas will be considered advantageous
  • Validation
  • Statistics
  • Process Analytics 

 

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.


 MSD is not accepting unsolicited assistance from search firms / recruitment agencies 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: Chemical Engineering
Other Locations: Luzern, Lucerne, CH
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Biochemistry, Microbiology, Biotech, Oncology, Medical, Science, Healthcare

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