Job Detail

JOB DESCRIPTION

Job Description

Senior Bioprocess Associates - Downstream

Our Biotech facility in Dublin is now seeking experienced Senior Bioprocess associates for 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. 

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

 
JOB DESCRIPTION & SPECIFIC OBJECTIVES  

  

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

 The latest addition to our Ireland family is our Biotech Facility in Dublin. The site will play a pivotal role in the manufacture of our biologics-based medicines, including in the area of immuno-oncology, and will expand our current internal network of biologics drug substance manufacturing plants when full manufacturing operations begin in 2021. Our Biotech Facility in Dublin will be our first ever Large-Scale Mammalian-Based Drug Substance Facility, with the mission and ambition to manufacture breakthrough medicines from Ireland serving patients around the world. This facility is a significant supplier of drug substances for our Immuno-Oncology treatments and will also be critical in the future supply of new biotechnology products to its global network. 

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

1st - Day, 3rd - Night

Valid Driving License:

Hazardous Material(s):

Number of Openings:

3

Requisition ID:R28169