About this role
Grifols, a global healthcare company since 1909, develops plasma-derived medicines and transfusion solutions in over 110 countries. Grifols Diagnostic Solutions seeks an Associate Process Development Chemist for the Manufacturing Support team in San Diego. The role supports process transfer activities including notebook, development, validation lots, manufacturing reagents, transcripts, and oligos under cGMP guidelines.
Assist senior staff with material reservation for oligo and reagent builds, label printing, bulking, filling, and packaging per draft Manufacturing Instructions. Perform documentation updates and provide manufacturing support. Maintain laboratory activities under supervision following cGMP.
Work in a cGMP laboratory environment with variable shift requirements, open to 1st, 2nd, and possibly 3rd shifts. Collaborate with Manufacturing Sciences/Support team on process transfers and validations. Participate in cost savings and process improvement activities.
Join an international team enhancing lives through innovative healthcare solutions. Gain hands-on involvement in process development, validation protocols, and commercial builds under supervision. Contribute to document updates for CAPA, validations, and improvements.
Requirements
- Bachelor’s in Chemistry, Biology, Biochemistry, or equivalent
- 2-4 years of related experience in a laboratory setting
- 1-2 years of GDP, GMP, and ISO 13485
- Working knowledge of cGMP/GLP
- Proficiency in Microsoft Office
- Working knowledge of analytical techniques for oligos or reagents
- Manufacturing experience in oligo synthesis
- Open to variable shifts including 1st, 2nd, and possibly 3rd
Responsibilities
- Provide support to Manufacturing Sciences/Support senior staff
- Assist in development of manufacturing processes to transfer oligos and/or reagents to Manufacturing
- Participate in process validation protocols with supervision
- Assist with simple Change Controls
- Participate in notebook, development, validation and commercial builds per written directions
- Maintain lab under cGMP conditions
- Author and update documents to support process improvement, CAPA, Validations
- Provide support for manufacturing process
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