We are seeking a Process Scientist to join a leading pharmaceutical company in Sligo, Ireland. This is an exciting opportunity where you will work within a critical New Product Introduction (NPI) initiative.
Key Responsibilities:
1. Utilize expertise in antibody drug conjugates (ADC) production science and manufacturing techniques to support technology transfer and ongoing production.
2. Partner with R&D and Drug Product Development teams to establish robust process control strategies for new product launches.
3. Contribute to gap assessments, facility compatibility studies, and process safety/risk assessments for new product introductions.
4. Lead design, implementation, and testing of single-use assemblies for sterile manufacturing of ADCs.
5. Act as Process Subject Matter Expert for equipment selection and commissioning activities.
6. Prepare scientific reports, technical documents, and presentations to update stakeholders on project progress.
7. Maintain processes compliant with safety, regulatory, and industry standards.
Requirements:
1. Degree in Chemistry, Biochemistry, Analytical Science, or related field with 3-5 years experience in biopharmaceutical industry, or Master's degree with 2-5 years experience, or PhD.
2. Minimum two years experience with conjugations, specifically Antibody or Protein conjugations.
3. Proven experience in large-scale ADC manufacturing, including conjugation and fill/finish operations.
4. In-depth understanding of chemistry involved in large molecule and protein conjugation.
5. Experience handling new product introductions and technology transfers to fill/finish manufacturing environments.