Senior Engineer, Drug Product Technology Transfer
Join our team of talented engineers and scientists at BioMarin as we continue to advance therapies for rare genetic diseases.
We are seeking a highly skilled Senior Engineer to lead the technical delivery of new product introductions and technology transfer projects. This role is based in Cork or Dublin and involves collaboration with cross-functional project teams to ensure compliance with specifications, regulatory guidelines, and right-first-time delivery.
Key Responsibilities:
* Lead the technical delivery of new product introductions and tech transfer projects
* Act as the technical SME for drug product (DP) filling operations
* Work in a matrix team environment with process development, QA, QC, analytical sciences, packaging, supply chain, and regulatory teams
* Support aseptic filling operations for technology transfers and life cycle management
* Develop data-driven strategies for process development/product characterization
* Design experiments for lab studies/analytical work with a high level of autonomy
* Author technical reports to support DP technology transfer and DP process and product characterization
Requirements:
* Strong understanding and hands-on experience in MSAT or process development or technology transfer
* Background in large-scale processing of biologic drug products
* Strong understanding and hands-on experience in MSAT, process development, or technology transfer
* Solid understanding of regulatory requirements and guidelines
* Proficient in technical writing
* Demonstrated ability to build strong partnerships and work effectively with diverse team members
* Excellent organizational, interpersonal communication, and problem-solving skills
About Us:
BioMarin is a world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.