Msat Lead Process Scientist

vor 2 Wochen

Basel, Schweiz Bayer Vollzeit

**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

**MSAT Lead Process Scientist (M/F/d)**

**PURPOSE**:
Are you passionate about understanding and explaining manufacturing processes and/or analytical methods? Do you care for the science behind drug products for biologicals?

Join us in our global organization of Manufacturing Science and Technology (MSAT) BioTech Drug Product and Analytical Methods in Basel. As Lead Process Scientist you report to the Associate Director MSAT BT DP AM and are responsible for following main tasks:
**YOUR TASKS AND RESPONSIBILITIES**:

- Support cGMP production of biological drug products for market supply.
- Leading technology transfer and process/method optimization development to cGMP manufacturing, and/or site transfers of commercial manufacturing processes as required.
- Leading cross-functional projects for analytical harmonization, analytical method transfer and respective technical troubleshooting.
- Providing ongoing technical support for change control, deviation investigations and CAPA management as required during development and commercial manufacturing of products.
- Maintain CMC manufacturing records and documentation (authoring and reviewing technical reports, protocols, technology transfer documents, authoring and signing CMC sections in regulatory filings, TRDs)
- Interact directly with CMOs on technical matters, represent MSAT in cross-functional teams, lead sub-teams.

**WHO YOU ARE**:

- MS/Ph.D. in biochemistry/biology/chemistry/pharmaceutics/ engineering or related field.
- Experience / technical knowledge with biotechnological drug product manufacturing (i.e., formulation, aseptic filling, sterilization) and/or analytical methods.
- Several years of experience in support of start-up, tech transfer, and/or sustaining cGMP commercial drug product manufacturing process operations in biopharmaceuticals.
- Good knowledge of analytical methodologies for biotechnology/Cell and Gene Therapy products to support trouble shooting, process design, process control strategies and method transfer.
- Knowledge of and experience in process and method validation requirements.
- Experience in outsourced biologics manufacturing and in guiding CMOs.
- Knowledge of cGMP regulatory guidelines.
- Authoring, updating, reviewing of technical documents, BLA & MAA drug product modules.
- Fluency in English, German is an asset.

**YOUR APPLICATION**

**Location**:
Switzerland : Basel-City : Basel

**Division**:
Pharmaceuticals

**Reference Code**:
786019

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