Job Description
We are seeking a skilled Process Scientist with experience in conjugation to join a leading pharmaceutical company. This is an exciting opportunity where you will contribute to a critical New Product Introduction (NPI) initiative, collaborating with diverse global teams in Research & Development and Drug Product Development.
Main Responsibilities:
* Apply deep knowledge of antibody drug conjugates (ADC) production science and manufacturing techniques to support the technology transfer process 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 use in 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 stakeholders on project progress.
* E nsure processes comply with safety, regulatory, and industry standards.
Requirements:
* 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.
* In-depth understanding of 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.
* Skills in Antibody Conjugation, Bioreactor, Protein Drug Development, and ADC Technical.