Senior Bioprocess Associate

Merck Gruppe - MSD Sharp & Dohme; Dunboyne; On-site; EUR 45,000 - 65,000; Full time

Job summary

A leading pharmaceutical company in Ireland seeks a Senior Bioprocess Associate to manage drug substance manufacturing processes. You will be responsible for executing operations in compliance with safety and quality standards, optimizing workflows, and utilizing your expertise in upstream and downstream processing within a highly regulated environment. The role supports a hybrid working model, focusing on delivering solutions to unmet healthcare needs.

Qualifications

• Experience of Upstream / Downstream Processing.
• Experience in a highly regulated pharmaceutical manufacturing environment.
• Proven record of accomplishments in a regulated industry.

Responsibilities

• Responsible for all procedures and processes in Drug Substance manufacturing.
• Execute an automated recipe using paperless technology.
• Drive to optimise processing activities with lean techniques.

Skills

Upstream Processing

GMP Operations

Biopharmaceutical Industry

Education

Level 7 qualification in a science or engineering discipline

Level 6 qualification with a minimum 4 years experience

Tools

Manufacturing Execution System (MES)

SAP

Delta V

Job description

Senior Bioprocess Associate

A fantastic opportunity has arisen for a Senior Bioprocess Associate. Bring energy, knowledge, innovation to carry out the following:

Responsibilities

• Responsible for all procedures and processes associated with the manufacture of Drug Substance at our manufacturing facility, at the highest standards of Safety, Quality and Compliance.
• Responsible for undertaking manufacturing operations involved in the production of biologic drug substance on the designated shift.
• Key responsibilities include the execution of an automated recipe using paperless technology in order to progress the drug substance through inoculation and cell culturing activities, leading to filtration and purification of the product.
• Be involved in setting up the single use equipment between runs, carrying out the production process according to world class GMP and EHS principles.
• Driving to optimise and improve the processing activities through use of standard work and lean processing techniques while supporting operations team to consistently deliver on specific Key Performance Indicators (KPIs).

Skills You Will Need

• Level 7 qualification in a science or engineering discipline, or Level 6 with a minimum 4 years experience.
• Experience of Upstream / Downstream Processing.
• Experience in a highly regulated pharmaceutical manufacturing environment would be desirable.
• Proven record of accomplishments in a regulated industry.
• Start-up experience in a large scale commercial drug substance facility, or similar.
• Maintain a high level of expertise and working knowledge of the process equipment.
• Can lead and deliver cross‑functional Operational Excellence projects / Initiatives.
• A proven ability to work with automated systems such as Manufacturing Execution System (MES), Systems Applications and Products (SAP), Delta V etc.
• Knowledge of applying Lean Six Sigma and Lean methodologies in a workplace environment.
• Possess a detailed overview of the overall upstream / downstream process, with expertise and working knowledge of the manufacturing process.

Required Skills

• Biopharmaceutical Industry
• GMP Operations
• Upstream Processing

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.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office‑based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today.