MSAT Senior Scientist

Stellenbeschreibung:

MSAT Senior Scientist

Department Info

The Manufacturing Science & Technology (MSAT) department in our Leverkusen site plays a central role in ensuring the technical success of drug product manufacturing. This team supports technology transfers, process validation, technology development, and troubleshooting across the Drug Product value chain. Working closely with internal and external stakeholders, MSAT drives robust process implementation, continuous improvement, and innovation at the Leverkusen site.

Job Summary

As MSAT Senior Scientist, you will be responsible for leading and supporting technology transfers, scale‑up activities, and process validation for drug product manufacturing, with a strong focus on Pre-Filled Syringes (PFS). You will act as a subject matter expert for drug product technologies, contribute to process and technology development, and support operational excellence across the site. The role combines strategic thinking with hands‑on involvement on the shopfloor, close client interaction, and cross-functional collaboration.

Job Responsibilities

Lead and support process scale‑up, development, and optimization of drug product manufacturing processes, with a primary focus on PFS and full process chains including thawing, formulation, filling, and assembly/packaging.
Drive technology transfer activities from development to clinical and commercial manufacturing, ensuring robust, compliant, and scalable processes.
Develop and execute scale‑up strategies, conduct risk assessments and process characterization, and design efficient process validation strategies aligned with internal and external stakeholders.
Author and review technical documentation (protocols, reports, submissions) and provide scientific support during audits and client interactions.
Troubleshoot manufacturing challenges, lead scientific investigations including root cause analysis and CAPA definition, and contribute to continuous improvement initiatives.
Support new product introductions by leading risk assessments and defining the process control strategy, and contribute to late‑stage projects by preparing process descriptions, process instructions, and Bills of Materials (BOMs).
Contribute to technology development at the site, including liquid and lyophilized vial filling, and serve as technical lead in proposal drafting for new clients.
Develop filter validation strategies, review related protocols and reports, and ensure alignment with regulatory and EU GMP Annex 1 requirements.
Demonstrate hands‑on engagement during tech transfer and manufacturing activities, while systematically sharing knowledge and contributing to team capability building.

Profile Description

Advanced degree (PhD or MS) in Biological Sciences, Engineering or a related field, with 3+ years (PhD) or 5+ years (MS) of pharmaceutical industry experience.
Over 3 years of project leadership experience, managing complex cGMP Drug Product manufacturing or development projects.
Deep understanding of Drug Product technologies, particularly PFS, and familiarity with liquid and lyophilized vial filling processes.
Solid knowledge of regulatory requirements and pharmaceutical standards, including EU GMP Annex 1, and strong experience with validation, risk assessments, and process characterization.
Proven ability to lead complex cross-functional projects involving multiple internal and external stakeholders.
Strong analytical and problem‑solving skills, with a data‑driven approach to troubleshooting and process improvement.
Excellent communication skills, with the ability to represent MSAT in client interactions, audits, and cross-functional meetings.
Hands-on, proactive mentality with the ability to work effectively on the shopfloor and support real‑time troubleshooting.
Ability to transfer knowledge effectively, contribute to team development, and support long-term MSAT strategy building.
Experience with project management tools and Minitab is an asset.

Offer

A meaningful impact on global healthcare: Contribute directly to the successful manufacturing of high‑quality drug products, supporting patients worldwide and shaping the future of our Leverkusen site’s technological capabilities.
A high-responsibility role at the heart of MSAT: Take ownership of end‑to‑end technology transfers, scale‑up strategies, and process validation, with a strong influence on sitewide process robustness and innovation.
An innovative environment: Work in a setting where scientific excellence, data‑driven decision making, and continuous improvement are truly valued and embedded into daily operations.
Cross-functional and client-facing exposure: Collaborate closely with Manufacturing, QA, Engineering, Development, and external partners, and represent MSAT during client interactions, audits, and project discussions.
Professional growth and development: Expand your expertise through hands‑on manufacturing exposure, advanced technology development projects, and opportunities to contribute to long-term strategy building. Training opportunities and development programs support your continued growth.
A culture of collaboration and knowledge sharing: Join a team that values openness, teamwork, and capability building, where your expertise will help develop the next generation of MSAT professionals.
Competitive compensation and benefits: Receive a market‑competitive salary and benefits package aligned with your experience and impact, along with the stability and career opportunities of a global biopharmaceutical organization.