Scientist I- Global Material and Parenteral Packaging Sciences
General:
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 Client.
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 Client’s early- and late-stage parenteral Antibodies, Antibody-Drug Conjugates as well as Eye Care and Neurotoxin products.
The ideal candidate will independently manage CCS characterization for Vials, Prefilled Syringes (PFS) and Cartridges to support drug product and combination products requirements.
Responsibility:
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 Client.
Qualifications:
Scientist I: 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.
