Corporate Microbiologist Associate

**Make your mark for patients**

We are looking for a motivated **Corporate Microbiologist Associate** to join us in our **Sites Quality Operations **team.

**About the role**

The primary purpose of the Corporate Microbiologist Associate is to be the point of contact for microbiology & virology to provide expertise, guidance, strategy for:

- Pharmaceutical and Biopharmaceutical commercial manufacturing, including quality and product lifecycle.
- Pharmaceutical and Biopharmaceutical development.
- Regulatory affairs, for the submission of new drugs to authorities’ approval.

In this role, you will also follow-up, evaluate, and cascade the impact of new regulations and evolving industry practices:

- By endorsing SME role for Regulatory intelligence.
- By representing UCB in industry organizations.
- By authoring position papers in microbiology / virology topics impacting the global organization.
- By acting as a corporate process owner, in global processes related to microbiology / virology.

**Who will you work with**

You will work with a team of microbiologist, part of the transversal Sites Quality Operations department in the corresponding area of Manufacturing, Engineering & HSE. You will partner with UCB site’s manufacturing & development, Quality Assurance, Regulatory Affairs, as well as with UCB external network.

**What will you do**

**_ Compliance:_**
- Review and assess the impact on a global scale of GMP/GLP & Pharmacopoeia changes for microbiology & virology related chapters.
- Give recommendations and if necessary, participate in implementations of regulatory changes microbiology / virology topics on a local scale. When appropriate, write position papers in microbiology / virology topics impacting the global organization.
- Ensure that corporate standards are up to date, by acting as a corporate process owner, in global processes related to microbiology / virology & reviewing standards related to sterility assurance and bioburden-controlled processes.
- Act as the RIN expert for microbiology/virology topics.

**_
Quality:_**
- Give recommendations and if necessary, participate in:

- The investigations related to major microbiology & virology issues across the organization.
- The review to ensure that protocols / reports for microbiology & virology methods suitability test issued by CMO / CLO and internal manufacturing quality operations are compliant with regulations, with internal standards, policies, and procedures.
- The review of major deviations & out of specifications for microbiology & virology issued by CMO / CLO and internal manufacturing quality operations to ensure that they are addressed in compliance with regulations, internal standards, policies, and procedures.
- The review of change control to ensure that major change control related to microbiology & virology issued by CMO / CLO and internal manufacturing quality operations are addressed in compliance with regulations internal standards, policies, and procedures.
- Provide guidance and expertise in the definition / implementation / lifecycle of microbial & viral control strategies for manufacturing.

**_
Regulatory:_**
- Give recommendations and if necessary, participate in review / approval of the submission file to ensure that cell bank & virology methods described are compliant with regulations and aligned with internal standard, policies, and procedures.

**Interested? For this role we’re looking for the following education, experience and skills**
- Master’s Degree
- Minimum 10 years of experience in pharmaceutical environment.
- Strong experience in pharmaceutical manufacturing environments & constrains, including quality assurance & control.
- Good knowledge in compendial microbiology & virology methods & GMPs in pharmaceutical industry.
- Good knowledge in operational excellence.
- Fluent in English & French.

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you

**About us**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

**Why work for us?**
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

**Learn more** about sustainability at UCB and how it is integrated into our business approach.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we