Head of Science and Pharmaceuticals at Headcount Engineering
Process Scientist
A West of Ireland-based Pharmaceutical Multinational is seeking to recruit a Process Scientist specializing in ADC (Antibody Drug Conjugate) to join a team of 3 other Process Scientists. The role involves tech transfer of the ADC process, generating documents (GAP assessments, cleaning assessments, etc.), CAPAs, master batch records, and process flow documentation. This position offers an excellent opportunity to advance your career within a dynamic environment.
Responsibilities:
1. Leverage detailed understanding of the science behind ADC manufacturing and the site manufacturing process.
2. Collaborate with Research & Development and Drug Product Development teams to develop and transfer robust, fit-for-purpose process control strategies for new products (NPI).
3. Author gap assessments, facility fit studies, process safety and risk assessments for NPI.
4. Design, onboard, and test single-use assemblies for sterile ADC manufacturing.
5. Serve as SME for equipment selection and C&Q activities for new equipment.
6. Prepare scientific reports, technical documentation, and presentations to communicate project status to stakeholders.
7. Ensure compliance with safety, regulatory, and quality standards.
8. Perform other duties as assigned.
Requirements:
* Graduate degree in Chemistry, Biochemistry, Analytical Science, or related discipline with 3-5 years experience (MSc) or 2-5 years experience (PhD) in the biopharmaceutical industry, specifically in ADC.
* Hands-on experience in ADC manufacturing facilities and/or upstream processing, UFDF, mixing, single-use systems, and chromatography.
* Detailed understanding of large molecule and protein conjugation chemistry, demonstrated through successful project execution.
* Desirable: Experience with new product introductions or technology transfers to fill-finish manufacturing facilities.
Additional Details:
* Seniority level: Mid-Senior level
* Employment type: Contract
* Job function: Quality Assurance and Science
* Industry: Pharmaceutical Manufacturing
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