Principal Research Scientist
The Analytical R&D department at AbbVie is seeking an experienced senior scientist, group leader preferably with expertise in the areas of process analytical, CMC, regulatory filings and pharmaceutical sciences.
The individual will be responsible to lead the analytical support of API development and commercialization while working with other functional areas to advance projects through the pipeline.
- Experience in leading cross-functional teams focused on drug substance control strategy and specification setting across all stages of API development. Sound understanding of overall CMC development.
- Expertise in analytical method development and validation, method transfer in a cGMP environment. Experience in working with CRO and CMO is highly preferred.
- Familiar with API control strategy, regulatory starting material (RSM) justification and mutagenic impurity (MI) assessment.
- Experience in filing IND/IMPD. Filing experience on NDA and/or MMA is not a must but considered as a plus.
- Experience in mentoring junior scientists and strong record of successfully influencing key stakeholders and collaborators to drive decisions.
- Excellent communication skills and demonstrated record of building lasting partnerships across organizational boundaries.
- Record of leading research focused on long-term competitiveness and experience in leveraging external innovation and resources to augment internal capabilities.
- Bachelors, Masters, or PhD with 14+ (BS), 12+ (MS), and 6+ (PhD) years of experience in pharmaceutical or related industry.
- Preferred educational background includes but is not restricted to Analytical Chemistry, Organic chemistry, Biochemistry, Pharmaceutical Sciences or Chemical Engineering.
Key Leadership Competencies:
- Builds strong relationships with peers and cross-functionally with partners outside of team to enable higher performance.
- Raises the bar and is never satisfied with the status quo.
- Learns fast, grasps the "essence" and can change course quickly where indicated.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures innovation and manages innovation to reality.