R&D Project Lead Method Validations & Transfers

About the company

Our R&D lab forms the analytical backbone of product development, method transfers, and the maintenance of a broad medicinal portfolio. As Project Lead, you are the scientific and practical driving force behind our analytical projects. You will daily guide a team of laboratory technicians in method development, troubleshooting, validation, and method transfers for our CDMO customers. You translate project goals into a well-thought-out experimental approach, steer the execution, and ensure that every project results in high-quality results.

Your tasks

You work closely with the lab supervisor, your fellow project leads, and with R&D, QC, and QA. In CDMO projects, you are the technical point of contact within the product transfer team. The main responsibilities are:

• You manage the daily laboratory activities within your projects and guide laboratory technicians both substantively and practically.
• You review their analysis plans and raw data, interpret the results together with them, and determine the next steps.
• You coach laboratory technicians in their technical growth and ensure that their work and documentation are GMP-compliant.
• You design the experimental setup for method transfers, validations, verifications, and development studies.
• You are the technical point of contact for method transfers for CDMO products, from the evaluation of the customer method to the transfer report.
• You lead method development, optimization, and troubleshooting, and support deviation investigations, root cause analyses, and CAPAs.
• You plan and monitor your projects: timing, priorities, risks, and communication to stakeholders.
• You draft protocols and reports according to VICH/ICH and internal SOPs.

Requirements

Do you match the required education and experience?

• Master's degree in pharmaceutical sciences, chemistry, or an equivalent field.
• At least 5 years of relevant experience in a pharmaceutical analytical lab.
• You are proficient in the chromatography of small molecules (HPLC/UPLC, possibly GC): you develop, optimize, and troubleshoot methods with insight.
• Demonstrable experience with method validation and method transfers and familiarity with pharmacopoeias (Ph. Eur., USP). Knowledge of statistical evaluation of validation and transfer data.
• Experience with Empower (Waters)

Do you possess these talents?

• Excellent project management skills: you plan, you set the right priorities, and you keep multiple projects under control simultaneously.
• Strong reporting skills in English.
• A strong focus on quality.
• You enjoy guiding people, communicate clearly, and collaborate smoothly across departments.

Other

Note: you are not allergic to penicillins.