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AbbVie Senior Scientist III, Dissolution Sciences in Lake County, Illinois

Senior Scientist III, Dissolution Sciences

USA, Illinois, Lake County

1 additional location

USA, Illinois

Research & Development

Requisition #1900836

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.

Scientific/Technical Leadership:

  • 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.

  • Mentorjunior scientists

  • Recognized and sought out as an expert indissolution within the company and possibly externally

Communication:

  • 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.

Project Coordination:

  • 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

Required:

  • 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.

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.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Additional Information

  • Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

  • Travel: No

  • Job Type: Experienced

  • Schedule: Full-time

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