Senior Specialist, MS&T (Upstream or Downstream)

Job Description

Are you passionate about biotechnology and eager to make a meaningful impact on patients lives We are looking for aSenior Specialist in Manufacturing Science and Technologyto join our Process Engineering team at our biotechnology facility in Dublin. Whether your expertise lies in upstream cell culture or downstream purification we welcome your unique perspective.

In this role you will provide vital technical support to our drug substance business. You will lead technical investigations support major site projects and help design qualify and transfer technology for manufacturing equipment. You will play a key role in ensuring we safely and reliably supply high-quality products while fostering an inclusive collaborative environment focused on continuous improvement.

Bring energy knowledge innovation to carry out the following:

• Lead Technical Investigations: Guide multidisciplinary teams to find the root causes of process deviations. You will lead root cause analyses implement effective Corrective and Preventive Actions and author product impact assessments to support safe batch releases.
• Drive Process Optimisation: Monitor and analyse commercial manufacturing trends using statistical process control and data analysis. You will use these insights to identify opportunities that improve process yield reliability and robustness.
• Support Technology Transfer & Projects: Play a key role in introducing new products to the site. You will support the execution of development and Process Performance Qualification batches manage change controls and assist with qualifying materials from suppliers.
• Manage Qualification Documentation: Design write review and execute qualification protocols and reports for manufacturing equipment and processes ensuring everything aligns with standard site practices.
• Foster Cross-Functional Collaboration: Lead and collaborate with diverse teamsincluding operations quality and regulatory partnersusing continuous improvement methodologies (such as Lean Six Sigma) to troubleshoot and streamline operations.
• Uphold Safety & Compliance: Maintain a strong Safety First Quality Always mindset. You will ensure all activities comply with global policies regulatory standards and current Good Manufacturing Practices while actively participating in internal and external regulatory audits.

What skills you will need:

In order to excel in this role you will more than likely have:

• Experience:At least 5 years of technical operations experience in commercial-scale drug substance manufacturing of biological molecules including hands-on experience with upstream cell culture and/or downstream purification.
• Education:A degree in Pharmaceutical Biological or Chemical Engineering or Sciences or a related discipline.
• Technical Expertise:Strong knowledge of upstream or downstream purification processes process control strategies and regulatory standards. Experience with process monitoring automation systems and data systems in a regulated environment is highly valued.
• Leadership & Collaboration:A proven track record of leading technical projects managing change and solving complex problems. You are an encouraging teammate who enjoys coaching others sharing knowledge and building inclusive relationships.
• Communication:Excellent technical writing skills and the ability to explain complex biological processes clearly to diverse teams.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the worlds 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 dont 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.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway 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.

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