Process Scientist We are seeking a Process Scientist 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.
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.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
Skills: ADC bioreactors filtration mAbs conjugation Antibody-drug conjugate