M&S-Quality Control Expert Microbiology IFB

About the job

Sanofi has decided to invest into a new large state-of-the art facility for Insulin Drug Substance in Beijing, China (IFB). For this green field operation, we’re enhancing our legacy of excellence and build on decades of expertise on the whole value chain of insulin manufacturing. The new facility will be designed as a fully automated, green, modern, and state-of-the-art biologics facility. A large global and highly cross-functional program organization will be established to lead and execute the program until commercial routine manufacturing.

Meet Katrin, our Global Program Leader, and discover how we’re transforming insulin production. Watch now!

Position Overview

The Microbiology Quality Control expert will work on establishing the Microbiology Quality Control laboratory at IFB during the planning phase, qualification through to final approval and transition to routine operations. Together with other Q-functions, the incumbent will develop procedures and documents to commission equipment and analytical methods in accordance with applicable GMP requirements, internal quality standards, and regulatory specifications.

As the project proceeds, this role is expected to evolve to functional leadership of team consisting of internal and/or external analysts and/or technicians to execute transfer, qualification, validation and test activities to support project hit the milestone in a compliance manner regarding on HSE, cGMP and Sanofi internal and external regulatory standards.

The Microbiology Quality Control Experts will report to the Microbiology Quality Control Lead IFB.

Main responsibilities:

• Provides microbiological analytical expertise for projects, troubleshooting and investigations related to analytical methods and laboratory technologies.

• Creates and reviews protocols and reports related to analytical verification/validation/transfer activities and qualification measures.

• Creates, reviews and maintains precise standard operating procedures for analytical methods for IFB and ensures the alignment with the sending unit in Frankfurt.

• Ensures the performance of all tasks (initially especially equipment qualifications, analytical transfers) in accordance with cGMP and HSE requirements as well as associated instructions, procedures and records

•Ensures the documentation of all required raw data, calculations and information to comply with cGMP and data integrity requirements

• Timely informs about quality or HSE-relevant events (deviations, OOx, etc.) to ensure appropriate investigation and impact assessment.

• Ensures proper documentation of deviations, non-conformities and corrective actions

• Ensures GMP-compliant execution and documentation of quality tests and workflows for pharmaceutical products.

Management:

• Is responsible of the delivery the microbiology quality control lab aspects of the project, within the allocated budget, schedule and the expected objectives, performances, HSE, Quality. Ensure the project is performed according to the Sanofi Standard and Good Practices.

• As a functional leader you support the Microbiology Quality Control Lead IFB in leading a team consisting of internal and/or external analysts and/or technicians. Provides appropriate training, mentoring and coaching.

• Ensures implementing statutory and company-specific occupational safety guidelines to prevent work accidents and occupational diseases within your area of responsibility. This includes regular communication of occupational safety topics and conducting occupational safety training based on risk assessments.

• Standardize operational processes and cost management with a focus on continuous improvement.

• Collaborates closely with the sending unit in Frankfurt, MSAT and global SME network.

About you

Experience

Degree in Microbiology/ Pharmacy/Biochemistry or Equivalent.

Ideally MSc or PhD level qualification in science.

Minimum of 5 years of pharmaceutical or biotechnological industry experience, preferably with practical experience in microbiology analytical method transfer/verification and/or instrument qualification and validation.

Experience in a project leadership positions with a proven track record of delivery and compliance.

Preferably with the knowledge & experience automation and/or LIMS.

Experience in scientific and technical writing

Effective oral and written communication skills, and innovative thinking.

Familiarity with strategic planning, balanced judgment and risk analysis.

Soft Skills:

Ability to drive and embrace change

Cross-functional collaboration

Leadership and assertiveness

People development

Negotiation and influencing skills

Communication skills

Decision-making

Technical Skills:

Proficient with typical microbiological techniques.

In-depth understanding of GMP principles and data integrity requirement.

GMP and health-regulated requirements

International and FDA experience

Languages:

International and FDA experience

Why choose us?

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Pursue Progress . Discover Extraordinary .

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !