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Senior Scientist III, Dissolution Sciences

Company: AbbVie
Location: Crystal Lake
Posted on: September 15, 2019

Job Description:

cGXP Documentation & Compliance: Maintain conformance with cGXP through compliance and documentation. Review and approve exception documents. Review and audit laboratory documentation (e.g. notebooks and packets) for experimental design and consistency. Scientific/Technical Leadership: Generate accurate, reliable data by following good scientific practices and procedures. Independently conduct study design, generate data, summarize, interpret and review data, with the goal to achieve project goals. Function as dissolution expert/technical resource in related analytical techniques and methods: Operate, maintain and troubleshoot instrumentation and equipment. Develop, validate and author dissolution methods and evaluate compendial procedures. Propose and justify targets or specifications from Phase I to NDA. Anticipate internal and external customer needs and proactively address them. Initiate and lead high-impact research programs to meet current and future pipeline needs of dissolution development (especially in clinically relevant methods) and modelling and simulation. Author (or co-author) internal and external posters, manuscripts, or podium presentations. Help establish Abbvie's reputation in the industry. Recognize areas for process improvements and lead successful implementation. Mentor junior scientists Recognized and sought out as an expert in dissolution within the company and possibly externally Communication: Author internal reports and regulatory submissions related to dissolution. Create and deliver logical, well organized presentations independently. Communicate results and issues and build alignment within the internal area, the project team and external organizations (e.g. Formulation, PK, Operation, Regulatory, Statistics, and QA). Actively engaged in benchmarking activities and bring back relevant info with the goal to influence strategies directions of the dissolution group. Project Coordination: Accept additional responsibilities beyond normal daily responsibilities to meet departmental, DPD, and DS needs and goals. Provide guidance to others on instrumentation, equipment and techniques. Manage and coordinate routine activities of exempt and non-exempt personnel Supervise technical group (including performance evaluation and growth planning for direct reports), if applicable. Level will be based on education & years of experience Required: Ph.D. in the areas of Pharmaceutics, Chemistry, Chemical Engineering, preferably with backgrounds in biopharmaceutics and physical chemistry At least 4+ years of experience in dissolution method development and validation, specification setting up, and regulatory submissions, with at least two NDA submission/authoring experience. Track record of scientific publications and/or external collaboration with peers through industrial organizations (e.g., consortiums, focus group, working groups). Familiar with global regulatory requirements on dissolution methods and specifications Comfortable in making decision and performing scenario analysis in ambiguity Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals. Preferred : Ph.D. in the areas of Pharmaceutics, Chemistry, Chemical Engineering, preferably with backgrounds in biopharmaceutics and physical chemistry 6+ years of experience in dissolution method development and validation, specification setting up, and regulatory submissions, with at least two NDA submission/authoring experience.

Keywords: AbbVie, Crystal Lake , Senior Scientist III, Dissolution Sciences, Other , Crystal Lake, Illinois

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