Job Title: Process Scientist
We are seeking a highly experienced Process Scientist with conjugation expertise to join our pharmaceutical team.
About the Role
This is an exciting opportunity where you will be working within a critical New Product Introduction (NPI) initiative, applying your expertise in antibody drug conjugates (ADCs) while collaborating with diverse global teams in Research & Development and Drug Product Development.
* As 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.
* You will partner with R&D and Drug Product Development teams to establish robust, fit-for-purpose process control strategies for new product launches.
* You will contribute to the creation of gap assessments, facility compatibility studies, and process safety/risk assessments for new product introductions.
* You will lead the design, implementation, and testing of single-use assemblies for use in the sterile manufacturing of ADCs.
* You will serve as Process SME for equipment selection and commissioning activities for new machinery.
* You will prepare detailed scientific reports, technical documents, and presentations to update both internal and external stakeholders on project progress.
* You will 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.
* 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 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.