Job Title: Process Scientist with Conjugation Experience
We are seeking a skilled Process Scientist to join our team and contribute to a critical New Product Introduction (NPI) initiative in the pharmaceutical industry.
Key Responsibilities:
* Utilize expertise in antibody drug conjugates (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 ADC sterile manufacturing.
* Process SME for equipment selection and commissioning activities.
* Prepare detailed scientific reports, technical documents, and presentations for internal and external stakeholders.
* Evaluate processes for compliance with safety, regulatory, and industry standards.
Requirements:
* Bachelor's or Master's degree in Chemistry, Biochemistry, Analytical Science, or related field.
* 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 with new product introductions and technology transfers.