Process Scientist Role
We are seeking a highly skilled Process Scientist with conjugation experience to join our team at a leading pharmaceutical company.
About the Opportunity
This is an exciting opportunity to work within a critical New Product Introduction (NPI) initiative, where you will apply your expertise in antibody drug conjugates (ADCs) and collaborate with diverse global teams in Research & Development and Drug Product Development.
Responsibilities
* 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 process control strategies for new product launches.
* Contribute to 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 sterile manufacturing of ADCs.
* Process SME for equipment selection and commissioning activities for new machinery.
* Prepare scientific reports, technical documents, and presentations to update internal and external stakeholders on project progress.
Requirements
* Degree in Chemistry, Biochemistry, Analytical Science, or related field with 3-5 years of biopharmaceutical industry experience, or Master's degree with 2-5 years of experience, or 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 chemistry involved in large molecule and protein conjugation.
* Experience in handling new product introductions and technology transfers to fill/finish manufacturing environments.