We are seeking a Process Scientist with conjugation experience to join a leading pharmaceutical in Sligo. This is a very exciting opportunity where you will be working within a critical New Product Introduction (NPI) initiative. This role will allow you to apply your expertise in antibody drug conjugates (ADC) while collaborating with diverse global teams in Research & Development and Drug Product Development. As the Subject Matter Expert (SME) for ADC processes, you will:
- Utilize your deep knowledge of ADC production science and manufacturing techniques to support the technology transfer process and ongoing production at the company.
- 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 the 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 both internal and external stakeholders on project progress.
- Ensure that all processes comply 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.
- Minimum two years experience with conjugations, specifically Antibody or Protein conjugations.
- 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.
