Job Title: Process Scientist
We are seeking a skilled Process Scientist with conjugation experience to join our team in the pharmaceutical industry.
This is an exciting opportunity where you will be working within a critical New Product Introduction (NPI) initiative, collaborating with diverse global teams in Research & Development and Drug Product Development.
About the Role:
* As Subject Matter Expert (SME) for ADC processes, you will utilize your deep knowledge of ADC production science and manufacturing techniques to support technology transfer and ongoing production.
* You will partner with R&D and Drug Product Development teams to establish robust process control strategies for new product launches.
* Contribute to gap assessments, facility compatibility studies, and process safety/risk assessments for new product introductions.
* Lead design, implementation, and testing of single-use assemblies for sterile manufacturing of ADCs.
* Process SME for equipment selection and commissioning activities for new machinery.
* Prepare scientific reports, technical documents, and presentations to update stakeholders on project progress.
Requirements:
* Bachelor's degree in Chemistry, Biochemistry, Analytical Science, or related field with 3-5 years of experience in biopharmaceutical industry.
* 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 chemistry involved in large molecule and protein conjugation.
* Experience in handling new product introductions and technology transfers to fill/finish manufacturing environments.