Job Description

An opportunity has arisen for a Drug Substance Manufacturing Specialist. In this position the Manufacturing Specialist will play a pivotal role in ensuring smooth operation of various aspects of manufacturing. In partnership with the site MS&T scientist the Manufacturing Specialist will provide comprehensive technical leadership to the DS organization.

Bring energy, knowledge, innovation to carry out the following:

• Provide Technical support within the manufacturing team, including areas such as Manufacturing, DS cell culture upstream and downstream manufacture.
• Support technical deliverables within Drug Substance to support the successful product launch.
• Provide technical support to the operations teams during Engineering Batches, Process Performance Qualifications and commercial manufacturing.
• Lead/participate in manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis is completed and appropriate CAPAs are implemented.
• Lead deviation root cause analysis and impact assessment.
• Identify and implement projects to continuously improve the compliance and manufacturing capabilities within the Manufacturing area.
• Creation and revision of technical documents including manufacturing batch records, Risk Assessments, SOPs and technical memos.
• Provide technical support for RFT implementation and execution.
• Support equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ
• Support Batch Disposition activities by providing SME technical support for comment resolution.
• Explain complex technical issues to external customers / agencies.
• Participate in Regulatory, Client and Internal audits inspections as the technical representative.

What skills you will need:

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

• Engineering or Science Degree or related discipline.
• 3 years working in a cGMP biological, vaccine or pharma facility (process development). Preferred candidate will have cGMP experience with biological, vaccine or pharma facility with prior aseptic manufacturing experience.
• Ability to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
• Previous experience of technical support of shakedown batches engineering batches, developmental batches and PPQ runs.
• Experience with cell culture, bioreactor operation and UFDF will be advantageous
• Previous experience with CQV activities will be advantageous.
• Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma.
• Experience in a risk-based approach to manufacturing through use of tools such as FMEA.
• Ability to adapt to changing priorities as project demands change.
• Understanding of USP1790 and industry/ regulatory requirements such as Annex 1.
• Demonstrated skills in planning, communication (oral and written) and technical writing.

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.

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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