This Subject Matter Expert is responsible for designing and implementing strategies for risk assessment and characterization of extractables and leachables, elemental impurities, and DNA reactive (mutagenic) impurities. The Subject Matter Expert will design and perform initial laboratory studies, manage the development and validation of analytical methodologies, and interface with CRO’s conducting longer term studies. This individual will be a subject matter expert and will provide knowledge and insight on appropriate regulatory compliance strategies. This position is a partially laboratory based role.
- Responsible for training and mentoring of more junior staff in areas of the incumbents’ subject matter expertise.
- Responsible for analytical support for extractables and leachables study design and analysis methods. Consults and lends expertise in analytical science concepts to other scientists and groups.
- Initiates, designs, accurately interprets, troubleshoots, and completes non-routine procedures independently and efficiently.
- Responsible, in collaboration with management, to develop and track project timelines. May deliver updates to senior level management in context of overall project goals.
- Effectively communicates and defends own work, orally and in writing, at team meetings, in technical documents, and to external partners. Participates in cross departmental project teams as required.
- Generates documents in support of regulatory submissions, and may author portions of CMC section of submissions.
- Proposes, evaluates and implements new technologies; independently applies scientific principles, technology and regulatory knowledge; performs literature searches, attends scientific meetings, and keeps abreast of literature relevant to analytical science in product development
- Hands-on-experience performing trace analysis of organic and elemental impurities, as well as development and validation of analytical methods used in testing of drug products by means of various procedures including HPLC/UV, HPLC/MS GC, GC/MS, and ICP-MS.
- Understanding of industry guidance provided by the FDA, ICH, and EMEA relating to container closure systems for drug packaging, elemental impurities, or mutagenic impurities.
- Working knowledge the current USP/NF, particularly USP <232>/USP <233>, USP <1086>, and USP <1663>/USP<1664>.
- Familiarity with toxicological assessment procedures and safety characterization of extractables.
- Experience performing risk assessment of leachables utilizing data sources provided by commercial, academic, governmental agencies.
- Broad knowledge of, or familiarity with, analytical development, and of processing and packaging materials.
- PhD in chemistry or closely related field with at least 8years of relevant hands-on experience in analytical development preferred, or
- Master’s degree in chemistry or closely related field with at least 12years of relevant experience.