About the job

Our Team:

Lead the analytical life-cycle management of microbial drug substances and products at Sanofi. As an expert in Analytical Life Cycle Management, the role will oversee method validation and analytical transfers, ensuring compliance with internal and external guidelines. The role will apply the expertise to drive continuous improvement in analytical processes. Furthermore, it combines technical expertise with project management skills to serve as a key resource for global guidelines related to analytical life-cycle management, ensuring the highest quality standards in our analytical development processes.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Expert for Analytical Life Cycle Management and Method Transfer/Validation within our MSAT, will be to support the launch of new products.

Main responsibilities:

Assessment of validation documents and identification of gaps to internal and external guidelines summarized in corresponding documents and quality actions.…

Support of Planning, coordination and evaluation of analytical transfer and validation strategies according to relevant guidelines and regulatory requirements with regards to new product introductions

Contributes to the analytical life cycle management strategy

Continuous further development of analytical life cycle management activities

Risk analysis in context of analytical life cycle management

Provide input to regulatory dossiers, provide responses to questions from authorities

About you

Experience: Development and manufacturing of pharmaceutical products, preferably in analytical sciences.

Soft and technical skills:

Experience, regulatory requirements, dossier writing, cGMP knowledge, HA regulations, quality systems, with outsourcing of activities and management of CMOs

Actively making decisions to drive related decision-making processes

Enjoying collaboration in interdisciplinary teams and being open and winning with

with people

Self-employed, organizational and purposeful

Ability to present and present even complex contexts accurately and comprehensibly

Anticipate risk and bring about proactive, effective and innovative solutions

Education:

PhD or Master in Science (University), Chemistry, Biochemistry, Biotechnology, Chemical engineering or Pharmacist

Languages:

Fluency in German and English, verbally as well as in writing

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.

Benefit from a well-thought-out benefits package that rewards your contribution and commitment.

We take care of you and your family with a wide range of health and social such as high-quality healthcare, numerous prevention programs and coverage for long-term illness. Our 14-week paid family leave for both parents is outstanding as well as a wide range of childcare benefits.

Start your career at an attractive location in the center of Germany and experience our modern working environment and benefit from hybrid, flexible working time models.

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!

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!