Process Scientist
We are seeking a Process Scientist to join a leading pharmaceutical company in Sligo. This is an exciting opportunity where you will work within a critical New Product Introduction (NPI) initiative. As the Subject Matter Expert (SME) for Antibody Drug Conjugates (ADCs), you will:
* Utilize your deep knowledge of ADC production science and manufacturing techniques to support technology transfer and ongoing production.
* Partner with R&D and Drug Product Development teams to establish robust, fit-for-purpose process control strategies for new product launches.
* Contribute to the creation of gap assessments, facility compatibility studies, and process safety/risk assessments for new product introductions.
* Lead the design, implementation, and testing of single-use assemblies for use in sterile manufacturing of ADCs.
* Process SME for equipment selection and commissioning activities for new machinery.
* Prepare detailed scientific reports, technical documents, and presentations to update internal and external stakeholders on project progress.
* Evaluate all processes to ensure compliance with safety, regulatory, and industry standards.
Requirements:
* A degree in Chemistry, Biochemistry, Analytical Science, or a related field, with 3-5 years of experience in the biopharmaceutical industry, or a Master's degree with 2-5 years of experience, or a PhD.
* Proven experience in large-scale ADC manufacturing, including conjugation and fill/finish operations.
* In-depth understanding of the chemistry involved in large molecule and protein conjugation, demonstrated by successful project outcomes.
* Experience in handling new product introductions and technology transfers to fill/finish manufacturing environments.