MSD QC Bioanalytical Manager 

Ireland, Dublin 

692541121

Job Description

QC Bioanalytical Manager,

The QC Bioanalytical Manager supports the site through qualification and operation of the full suite of QC Bioanalytical methods. The role ensures that the QC team objectives are effectively achieved, consistent with business requirements to ensure compliance, safety and reliable supply to our customers. Bring energy, knowledge, leadership, and innovation to carry out the following:

What you will do:Bring energy, knowledge, innovation, and leadership to carry out the following:

• Ensure all QC testing is completed for in process, release and stability testing of Drug Substance, including compendial methods, HPLC, CE-SDS, Bioassays, Elisa, DNA as well as Raw materials and utilities testing including WFI.
• Manage, coach and mentor a team of QC analysts. Build diverse talent with the capabilities necessary to succeed in commercial manufacture.
• Inspire Diversity and Inclusion – building effective working relationship within a cross-functional team across different cultures and backgrounds.
• Responsible for reviewing and approving GMP documentation to support QC Labs compliance /regulatory expectations for QC operations.
• Author/review technical documents, standard operating procedures, change controls, and investigations related to QC Testing and methods.
• Assisting in and facilitating investigations (leading where required), ensuring effective Root Cause Analysis and CAPAs.
• Support various site functional and cross functional tier structures.
• Work cross-functionally with our company's internal sites and global partners to build and operate testing capability within the QC lab.
• Be an advocate for continuous improvement, new technologies and innovation.
• Apply project management concepts and techniques, as they relate to planning and test method execution, to meet established delivery timelines.
• Trouble-shoot laboratory process and equipment issues as needed.
• Actively participate in Site/Quality committees and works with other site functional groups to help set direction for GMP and continuous improvement initiatives.
• Represent the QC department during Regulatory Inspections and other internal GMP inspections.

Qualifications

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

• Degree (or higher) in Chemistry, Biology or in a relevant discipline, the successful candidate will also have significant exposure in delivering operational excellence in GMP environment.
• This role requires a seasoned professional with the expertise (10 years) and attributes that will ensure success in this highly accountable role.
• Working knowledge in the biotech industry is required with specific understanding of QC operations, regulatory agency engagement and ability to gain alignment on strategy.
• The successful candidate should have the knowledge and ability to mentor the bioanalytical methods implemented at the site.

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,
please apply today.

Current Contingent Workers apply

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