AbbVie Senior Scientist III, Process R&D CMC Regulatory Liaison in Lake County, Illinois

Description:
The primary function of the Senior Scientist III, Process R&D CMC Regulatory Liaison, within the Scientific Affairs department of Process R&D is to ensure consistent preparation of drug substance sections of regulatory submission documents of high scientific and technical quality that are compliant with global regulatory requirements. In addition, the individual will implement well-defined, efficient processes for preparation, review and approval of Chemistry, Manufacturing, and Controls (CMC) sections of submission documents. The individual will serve as a key member of CMC teams, ensure that CMC submission strategy is aligned with the clinical/regulatory development strategy, and provide drug development experience and advice to the CMC teams. The individual will work with project teams within the Process Research & Development organization to enable the successful development of drug substance manufacturing processes and control strategies by combining knowledge of scientific and regulatory issues.

Key Responsibilities include: * Ensure consistent preparation of drug substance sections of regulatory submission documents of high scientific and technical quality that are compliant with global regulatory requirements, through the use of well-defined, efficient processes * Author, coordinate and format submission documentation for all phases of clinical development, with emphasis on later phase programs and marketing applications * Responsible for contributing to and implementing regulatory filing strategies * Provide drug development experience and advice as appropriate to CMC teams * Maintain awareness of global regulatory requirements on pharmaceutical development * Serves as primary drug substance development interface with the CMC Regulatory group * Assist CMC project teams in planning, preparation, review and approval of submission documentation * Along with CMC Regulatory, assist CMC project teams in identifying submission-related risks and develop mitigation strategies * Contribute responses to inquiries from regulatory authorities and interact with regulators during inspections * Interface with CMC Regulatory personnel to ensure consistency across projects

Qualifications:
Position will be hired based on level of education and experience

Basic: * Bachelors, Masters, or Ph.D in Chemistry or Chemical engineering with a minimum of 12 years (BS), 10 years (MS), or 6 years (Ph.D.) of relevant pharmaceutical development experience. * Demonstrated knowledge of API manufacturing process development, control strategies, and regulatory guidance’s is required * Proven negotiation skills, oral and written communication skills, and influencing skills * Proven ability to work independently with minimal supervision * Strong understanding of business needs and the impact of regulatory issues * Demonstrated ability to collaborate with allied areas

Preferred: * Ph.D in Chemistry or Chemical Engineering with a minimum of 8 years of pharmaceutical development experience

Key Leadership Competencies: * Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance * Learns fast, grasps the 'essence' and can change the course quickly where indicated * Raises the bar and is never satisfied with the status quo * Creates a learning environment, open to suggestions and experimentation for improvement * Embraces the ideas of others, nurtures innovation and manages innovation to reality

Job Classification: Experienced
Job: RESEARCH AND DEVELOPMENT
Primary Location: USA-Illinois-Lake County
Organization: Research & Development
Schedule: Full-time
Shift: Day
Travel: Yes, 10 % of the Time
Req ID: 1700344

Equal Opportunity Employer Minorities/Women/Veterans/Disabled