Senior Bioprocess Associate Job

Date: Apr 11, 2019

Location: Dublin, IE

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Requisition ID: TEC001373

Upstream/Downstream Senior Bioprocess Associate


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, Keytruda and will also be critical in the future supply of new biotechnology products to its global network.

Our MSD Biotech facility in Dublin is now seeking experienced
Senior Bioprocess Associates for Upstream/Downstream Commercial Large-scale Drug Substance manufacture.
This is a great opportunity to join during a start-up phase where you can develop that in-depth knowledge that only a start-up will afford you.
These roles will be initially day based to support project start up but will migrate to a permanent 24/7 shift cycle as per business requirements.

& SPECIFIC OBJECTIVES

• The Senior Bioprocess Associate is responsible for all procedures and processes associated with the Manufacture of Commercial Large-Scale Drug Substance at MSD Biotech, Dublin.

• The Senior Bioprocess Associate will be responsible for the preparation, operation and monitoring of equipment, use of business systems and carrying out tasks including but not limited to the cleaning, validation, in-process testing and basic maintenance of equipment in accordance with current Good Manufacturing Practices (cGMPs).

• The Senior Bioprocess Associate will coach and mentor Bioprocess Associates on an ongoing basis.

• The Senior Bioprocess Associate will operate to the highest standards of Safety, Quality and Compliance.

POSITION RESPONSIBILITIES

• Work with the manufacturing operations group, project design team, the CQV team, the Automation/CSV reps to facilitate the development and validation of the MSD, Biotech facility manufacturing facility.
• Support Equipment Design/ HAZOP and Room programming reviews as per requirements.
• Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. EHS metrics, Production Plan, OEE, compliance and team training.
• Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures.
• Work as part of a dedicated process team where flexibility and teamwork are a key requirement
• Generate SOPS/Electronic Batch Records for start-up.
• Adhere to Right First-Time principals
• Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.
• Escalate issues as appropriate.
• Maintain a high level of personal expertise and working knowledge of all aspects of the manufacturing process and process equipment through continuous training and development.
• Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan.


REPORTING STRUCTURE
- The Senior Bioprocess Associate will report to the Manufacturing Shift Manager, Operations.

Qualifications

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

General
• Demonstrated successes in a team environment, such as project teams, Lean Six Sigma team, etc.
• Demonstrated problem solving capabilities.
• Knowledge of applying Lean Six Sigma and Lean methodologies in a workplace environment.

Technical
• Experience in a highly regulated drug substance manufacturing environment is essential.
• Start-up experience in a large scale commercial drug substance facility desirable but not essential.
• Excellent understanding of Upstream/Downstream Processing.


 


People
• Ability to interact with multiple stakeholders across numerous departments
• Excellent communication skills and the ability to work in a cross functional collaborative environment.
• Good interpersonal skills, attentiveness and an approachable manner for interactions with inter-departmental colleagues.
• high degree of problem solving ability and adherence to scheduled timelines.

Education
• Minimum of a Level 7 qualification in a science or engineering discipline.
• A level 6 with a minimum of 4 years’ experience in a GMP Manufacturing requirement shall be deemed equivalent.


Experience
• A minimum of 4 years’ experience in a Drug Substance Manufacturing facility is essential.

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: Technician-Biochem Manuf
Other Locations:
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, Oncology, Biotech, Engineer, Biology, Science, Healthcare, Engineering

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