Key skills
RChange Management
About this role
Role Overview
- Manage the Manufacturing Science and Technology (MSAT) Drug Product technical delivery for drug product manufacturing of a defined product or product family.
- Work closely with R&D, manufacturing sites, quality, regulatory and external partners to ensure safe, robust and compliant supply.
- Act as the single technical point of contact for the drug product portfolio, owning technical risk, decision-making and product knowledge.
- Manage and deliver technology transfers to internal sites and external manufacturers, including transfer packages, training and readiness reviews.
- Manage continued process verification, process performance qualification and change management to maintain product robustness and compliance.
Requirements
- Degree in a relevant technical, scientific or engineering discipline (for example pharmacy, chemistry, chemical/biochemical engineering).
- Knowledge / experience in drug product manufacturing, MSAT, process development or technical transfer roles in the pharmaceutical industry.
- Practical knowledge of risk tools (for example FMEA), control strategy development and statistical concepts for CPV.
- Demonstrable experience of technology transfer, process validation or continued process verification.
- Knowledge of good manufacturing practice (GMP) and product lifecycle management principles.
- Experience working in cross-functional teams and managing stakeholder expectations.
Benefits
- bonuses
- eligibility to participate in our share-based long-term incentive program