New 
Scientist I- Global Material and Parenteral Packaging Sciences
 Spectraforce Technologies | |
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 May 05, 2026 | |
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Position Title: Scientist I- Global Material and Parenteral Packaging Sciences
Work Location: Irvine, CA 92612 Assignment Duration: 2 yrs Work Arrangement: 100% Onsite Position Summary: The PDS&T Global Material and Parenteral Packaging group within Operations Science & Technology organization supports manufacturing, process validation, regulatory submission, and continuous improvement for late-stage and commercial manufacturing of biological products at The Organization. We have an exciting opportunity for a Scientist I based in Irvine, CA and are seeking a highly motivated Scientist I to join in our team and lead project activities related to the design, evaluation and implementation of Container Closure System (CCS) development for The Organization's early- and late-stage parenteral Antibodies, Antibody-Drug Conjugates as well as Eye Care and Neurotoxin products. Background & Context: This role supports container closure systems for parenteral drug products in a lab-focused product development environment. Key Responsibilities: * Planning, preparation, execution and evaluation of experiments for development of container closure systems for new parenteral drug products, namely liquid drug preparations of biotechnological drugs in vials, pre-filled syringes and cartridges as well as lyophilizates. * Evaluation and implementation of testing methods for CCS with a focus on continuous improvement and adherence to Regulatory requirements. * Responsibility for assigned laboratory equipment. Ensure required maintenance, documentation, and user training. * Authoring comprehensive, scientifically sound reports that could serve as source documents for authority submissions. * Collaboration with third party labs and/or manufacturing sites. * Coordination of suppliers for materials, equipment, and services. * Documentation of all work according to applicable GSP or GMP and internal procedural requirements. * Supporting continuous landscaping programs for innovative CCS, implementing and characterizing new CCS techniques. * Presentation of project data as well as SME topics in internal global teams. * Interacting professionally and effectively with peers and management within The Organization. Qualifications & Experience: *Bachelor's Degree or equivalent education with 1-2 years of experience in Analytical Chemistry, Material Sciences, biomedical, Chemistry, Physic, or related fields, preferably with Master's degree. * Good technical and scientific understanding of parenteral drug product development and regulatory guidelines. * Ability to develop comprehensive test plans and evaluate design concepts to ensure CCS meets stakeholder needs. * Ability to effectively identify and communicate risks. * Understanding of relevant scientific literature and ability to apply theoretical framework to solving problems within scientific discipline in a timely manner. * Detail oriented and good track record in delivering reliable and consistent results. * Working knowledge of regulatory requirements for parenteral pharmaceutical and biopharmaceutical products, packaging materials and drug/device combinations products is desired. * Scientific expertise in statistical data analysis is a plus. * Able to work with cross functional teams including R & D, Science & Technology, Operation, Quality, Regulatory, etc. * Excellent oral communication skills as well as sound technical writing and documentation competencies are required. | |