- The candidate will lead activities associated with process development and characterization for new ADC drug substances.
- Lead the design and execution of process development and control strategies.
- Lead process chemistry development for FIH programs.
- Proactively advise and share knowledge and expert opinions with subordinates, peers, and senior management. Mentor staff in troubleshooting strategic and experimental issues.
- Author and review key regulatory documents, laboratory data, technical memos and reports.
- Collaborate to ensure successful CMC interactions with regulatory authorities.
- The position involves multi-disciplinary interactions with other chemists, analytical chemists, engineers, drug product development, and program management. The selected candidate will collaborate with Asset Development Teams to advance clinical candidates. It is expected that the candidate will utilize his/her expertise across CMC disciplines to further program goals via collaborations with drug product development, regulatory affairs, and commercial operations.
- The candidate will encourage ideas for continuous improvement activities and initiatives within work group.
- The candidate will understand and adhere to corporate standards regarding code of conduct, safety and GXP compliance.
- BS (16+ years); MS (14+ years) or PhD (8+ years) in Chemistry or allied field, with 8+ years of previous work experience in a pharmaceutical laboratory setting.
- Experience in antibody-drug conjugate process development.
- The successful candidate will have a strong understanding of process development, control strategy development, regulatory starting material strategies, specification setting, QbD principles, tech transfer and process validation requirements.
- Interacts well with diverse groups within function and maintain strong working relationships with internal and external collaborators to enable higher performance.
- Learns fast, grasps the "essence" and can change 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.
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Principal Research Scientist I/II - North Chicago, United States - AbbVie, Inc
Description
Company DescriptionAbbVie (
NYSE:
ABBV) is a global, research-based biopharmaceutical company formed in 2013, following separation from Abbott.
AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader, to develop and market advanced therapies that address some of the world's most complex and serious diseases.
AbbVie employs approximately 50,000 people worldwide and markets medicines in more than 170 countries.AbbVie Process Chemistry is responsible for the chemical development of AbbVie's clinical candidates.
We are seeking a Principal Research Scientist II to conduct process research and development of antibody-drug conjugates from pre-clinical through clinical development.
Job Description
We are looking for a highly motivated person who can drive the development of antibody-drug conjugate drug substances, from FIH programs to late-stage development.
The candidate will lead a group of scientists in the development of conjugation chemistry as well as downstream unit operations culminating in drug substance and may have supervisory responsibilities.
The candidate will serve as the chemistry representative on the CMC team for ADC development programs and as such would be responsible for developing timelines and executing activities required for drug substance.
The candidate must be able to mentor and develop staff with novel experimental approaches to answer difficult scientific questions. Working with analytical and manufacturing colleagues, the candidate will develop productive collaborations and communications with scientific teams.Responsibilities:
Key AbbVie Competencies:
Additional Information
Applicable only to applicants
