About the Opportunity
We are seeking a highly skilled Process Scientist with extensive experience in conjugation to join our team at a leading pharmaceutical company. This is an exciting opportunity for you to apply your expertise in antibody drug conjugates (ADC) while collaborating with diverse global teams in Research & Development and Drug Product Development.
As the Subject Matter Expert (SME) for ADC processes, you will be responsible for:
* Utilizing your deep knowledge of ADC production science and manufacturing techniques to support the technology transfer process and ongoing production.
* Partnering with R&D and Drug Product Development teams to establish robust, fit-for-purpose process control strategies for new product launches.
* Contributing to the creation of gap assessments, facility compatibility studies, and process safety/risk assessments for new product introductions.
* Leading the design, implementation, and testing of single-use assemblies for use in the sterile manufacturing of ADCs.
* Processing SME for equipment selection and commissioning activities for new machinery.
* Preparing detailed scientific reports, technical documents, and presentations to update both internal and external stakeholders on project progress.
* Ensuring 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.