QC Microbiological Manager

Job Description

A fantastic opportunity has arisen for a QC Microbiological Manager, this is a key site technical leadership position within the QC department, that will manage the Micro technical team (and other technical personnel as required). This position carries the remit and accountability to enable the site to bring the very best of innovation to the oncology patients of the world who are counting on us to deliver.

This role supports the site through qualification and operation of the full suite of QC Microbiological methods. The role ensures that the QC team objectives are effectively achieved, consistent with site 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 to carry out the following:

• Ensure all QC testing is completed for in process, release and stability testing of Drug Substance, as well as utilities testing including WFI and Environmental monitoring.
• Manage, coach and mentor a team of QC technical team and others as required. 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/approve 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.

What skills you will need:

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 (8 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 rapid microbiology methods implemented at the site.
• As a company, we are dedicated to 'Inventing for Life' in all that we do. 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 a company, we are committed to ‘Inventing for Life’ in all that we do. 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. 

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.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

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