Senior Principal Research Scientist / Principal Research Scientist II
About The Position
AbbVie Process Chemistry is seeking a Senior Principal Research Scientist to conduct process research and development of drug conjugates, peptides, and small molecules from pre-clinical through early clinical phases. The candidate will lead the setting and implementation of the Process Chemistry strategy for projects across therapeutic modalities and will serve as a cross-functional expert influencing overall strategy across Synthetic Molecules CMC R&D. The candidate will lead project teams in process development and characterization across modalities. Lead the development and characterize processes in the laboratory and translate them to scalable processes. Proactively advise and share knowledge and expert opinions with subordinates, peers, and senior leadership. Mentor staff in troubleshooting strategic and experimental issues. Author and review key regulatory documents, laboratory data, technical memos and reports. The position involves multi-disciplinary interactions with organic chemists, analytical chemists, engineers, drug product development scientists, asset strategy leadership, and program management. The candidate will identify and nurture ideas for continuous improvement activities and initiatives across Synthetic Molecules CMC R&D. The candidate will be responsible for setting project strategies, defining project responsibilities and timelines, developing control strategies, providing leadership in a matrixed team setting and developing robust processes for cGMP manufacturing.
Requirements
- Experience managing and developing scientific leaders and teams in CMC is required.
- Proven scientific leadership; strong interpersonal and communication skills for facilitating collaborations and a demonstrated ability to lead cross-functional process development teams and represent program strategy to allied functions and leadership.
- The successful candidate will have a strong understanding of modern organic chemistry, mechanistic theory, control strategy development (including mutagenic impurity and nitrosamine controls), and regulatory starting material strategies.
Nice To Haves
- Experience with siRNA, antibody drug- and oligonucleotide-conjugates (AOCs), and high-potent compounds is preferred.
- An understanding of global regulatory expectations and experience with authoring development reports and regulatory filings is highly desirable.
Responsibilities
- Lead the setting and implementation of the Process Chemistry strategy for projects across therapeutic modalities and will serve as a cross-functional expert influencing overall strategy across Synthetic Molecules CMC R&D.
- Lead project teams in process development and characterization across modalities.
- Lead the development and characterize processes in the laboratory and translate them to scalable processes.
- Proactively advise and share knowledge and expert opinions with subordinates, peers, and senior leadership.
- Mentor staff in troubleshooting strategic and experimental issues.
- Author and review key regulatory documents, laboratory data, technical memos and reports.
- Identify and nurture ideas for continuous improvement activities and initiatives across Synthetic Molecules CMC R&D.
- Responsible for setting project strategies, defining project responsibilities and timelines, developing control strategies, providing leadership in a matrixed team setting and developing robust processes for cGMP manufacturing.
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k)
- long-term incentive programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
