Job Details

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.