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Senior Chemist

Company: Ultimate Staffing
Location: Irvine
Posted on: September 17, 2020

Job Description:

We are looking for an experienced scientist in material science, polymer chemistry, or organic chemistry with expertise in materials used in medical devices to join our high-paced, and dynamic team. The senior scientist will apply his expertise in materials chemistry to interpret data and provide solutions for complex problems. The senior scientist role requires an organized, proactive, self-starter who possesses excellent multi-tasking and communication skills and is comfortable interacting with a diverse team ranging from management staff to technical chemists, biologists, toxicologists, and engineers. This role will support a dynamic and key organization that is instrumental in developing our life saving products. This is a great opportunity to work in a leading medical device company with possibilities for growth.Essential Job Functions:--- Writing material characterization reports for a diverse range of medical devices. These reports assess the raw material chemical makeup and manufacturing processes to identify potential extractables, ensure compliance with ISO 10993-18 chemical characterization, and serve as an invaluable resource for L&E chemistry and toxicology teams.--- Providing consulting support on questions of materials formulations such as polymeric and metallic products, coatings, polymer additives, pigments/dyes, surface treatment agents, surfactants, solvents, processing aids, etc.--- Assisting in understanding materials formulations, ingredient concentrations and, importantly, illustrating how the constituent elements interact with a wide variety of chemical treatments, manufacturing processes, and sterilization modalities--- Supporting different business units in materials selection and management, giving guidance on material compatibility with different chemicals and processes--- Assisting in the critical review and understanding of leachable/extractable profiles, and support in identifying root cause analysis for process product failures, non-conformances, and CAPA.--- Assisting the Edwards Quality Laboratories to make decisions concerning product safety, innovation, quality, and product performance--- Providing creative and critical support in the construction of an enhanced database for specific formulations and materials used in Edwards' devices--- Knowledge of laboratory chemical analysis techniques (e.g., GCMS, LCMS, ICP, FTIR, XRD/XPS/EDS, SEM, etc), and ability to critically interpret test methods and generated data--- Working closely with suppliers and both internal/external product teams to obtain detailed chemical and compatibility information for materialsTop Requirements/Skills:--- The candidate should have a Bachelor's Degree in Materials Science, Polymer Chemistry, Chemistry, Chemical Engineering, or related field with 6 years of experience required, or Master's Degree in indicated field with 4 years of experience required, or PhD in indicated field with 2 years of experience required.--- Note: general preference is for bachelors or masters candidate, but we would consider PhD as well--- The candidate should have experience in the medical device industry or pharmaceutical industry (or relevant university experience) and possess a familiarity with common biomedical materials as well as manufacturing, cleaning, and sterilization processes.--- The candidate should have an understanding of biomedical material formulations, typical ingredient concentrations and be capable of illustrating how constituent elements interact with a variety of chemical treatments, manufacturing processes, and sterilization modalities.--- The candidate should have a familiarity with material leachable/extractable profiles (e.g. to ISO 10993-18 or USP guidelines) and common laboratory chemical analysis techniques (e.g., GCMS, LCMS, ICP, FTIR, XRD/XPS/EDS, SEM, etc)--- Note: Candidate does not need to be an expert in these topics, but some exposure to these fields is highly preferred. Candidate does not need to have experience in all chemical analysis techniques listed, a subset is ok.--- Strong verbal and written communication abilities, as well as ability and comfort to work with a wide variety of teams and staff in a fast pace and busy environment.Additional Skills:--- Expertise in critically reviewing materials documentation including but not limited to SDS, CoA/CoC, technical drawings, technical data sheets, and analytical test reports--- Comfortable in working with uncertainty and working with incomplete or unavailable information. Skilled in identifying and closing information gaps.--- Exceptional literature review and report generation skills--- Excellent problem-solving, organizational, analytical and critical thinking skills--- Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives--- Proven expertise in MS Office; analytical equipment system (e.g., ChemStation, Empower, etc.); citation management software (e.g. EndNote)--- Ability to manage confidential information with discretion--- Knowledge of Environmental Health and Safety and Quality guidelines--- Strict attention to detail and project management skillsEducation and Experience:--- Bachelor's Degree in Materials Science, Polymer Chemistry, Chemistry, Chemical Engineering, or related field with 6 years of experience required, or Master's Degree in indicated field with 4 years of experience required, or PhD in indicated field with 2 years of experience required.--- The candidate should have experience in the medical device industry or pharmaceutical industry (or relevant university experience) and possess a familiarity with common biomedical materials as well as manufacturing, cleaning, and sterilization processes. Experience in material selection, and deformulation efforts are a plus but not required.

Keywords: Ultimate Staffing, Irvine , Senior Chemist, Other , Irvine, California

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