Senior Scientist III, Dissolution Sciences

Employer
AbbVie
Location
Lake County, IL, US
Posted
Sep 08, 2019
Ref
1900836
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.