AbbVie Senior Scientist III, Dissolution Sciences in North Chicago, Illinois
Senior Scientist III, Dissolution Sciences
USA, Illinois, Lake County
1 additional location
Research & Development
cGXP Documentation &Compliance:
Maintain conformance with cGXP through compliance anddocumentation.
Review and approve exception documents.
Review and audit laboratory documentation (e.g. notebooks andpackets) for experimental design and consistency.
Generateaccurate, reliable data by following good scientific practices and procedures.Independently conduct study design, generate data, summarize, interpret andreview data, with the goal to achieve project goals.
Functionas dissolution expert/technical resource in related analytical techniques andmethods:
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.
Anticipateinternal and external customer needs and proactively address them.
Initiate and lead high-impact research programsto 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. Helpestablish Abbvie’s reputation in the industry.
Recognizeareas for process improvements and lead successful implementation.
Recognized and sought out as an expert indissolution within the company and possibly externally
Author internalreports and regulatory submissions related to dissolution.
Create and deliverlogical, well organized presentations independently.
Communicate resultsand issues and build alignment within the internal area, the project team andexternal organizations (e.g. Formulation, PK, Operation, Regulatory,Statistics, and QA).
Actively engaged inbenchmarking activities and bring back relevant info with the goal to influencestrategies directions of the dissolution group.
Accept additionalresponsibilities beyond normal daily responsibilities to meet departmental,DPD, and DS needs and goals.
Provide guidance toothers on instrumentation, equipment and techniques.
Manage and coordinateroutine activities of exempt and non-exempt personnel
Supervise technicalgroup (including performance evaluation and growth planning for directreports), if applicable.
Level will be based on education & years of experience
Ph.D. in the areas of Pharmaceutics, Chemistry,Chemical Engineering, preferably with backgrounds in biopharmaceutics andphysical chemistry
At least 4+ years of experience in dissolutionmethod development and validation, specification setting up, and regulatorysubmissions, with at least two NDA submission/authoring experience.
Track record of scientific publications and/orexternal collaboration with peers through industrial organizations (e.g.,consortiums, focus group, working groups).
Familiar with global regulatory requirements ondissolution methods and specifications
Comfortable in making decision and performingscenario analysis in ambiguity
Demonstrate creative'out of the box' thinking to solve difficult technical problems and championnew technologies to achieve project goals.
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.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced