Senior Scientist III, Dissolution Sciences
- Employer
- AbbVie
- Location
- Lake County, IL, US
- Start date
- Sep 8, 2019
View more
- Discipline
- Science/R&D, Biotechnology
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- BioMidwest, Best Places to Work
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Job Details
cGXP Documentation & Compliance:
Scientific/Technical Leadership:
Communication:
Project Coordination:
Level will be based on education & years of experience
Required:
Preferred:
- 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.
Company
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.
Stock Symbol: ABBV
Stock Exchange: NYSE
Company info
- Website
- http://www.abbvie.com/
- Phone
- 1-800-255-5162
- Location
-
1 North Waukegan Road
North Chicago
Illinois
60064
US
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