Responsibilities
- Responsible for leading the analytical aspects of a project including control strategy development, specification justification, method development and validation, data generation, and regulatory submission contributions.
- Proficiency with the relevant analytical techniques to support development of peptide products including the active pharmaceutical ingredient, intermediates, starting materials, impurities and impurity profiling.
- Support new product development with advanced methods development and validations, technical transfer packages, and generation of technical data to support regulatory requirements.
- Highly autonomous and productive in performing laboratory research or method development independently, requiring only minimal direction from a supervisor.
- Formulate conclusions and design follow-on experiments based on multidisciplinary data.
- May initiate new areas of investigation that are scientifically meaningful, reliable, and can be incorporated directly into a research or development program.
- Process, interpret, and visualize data to facilitate project team decisions.
- Communicate and collaborate with cross-functional groups and departments.
- Routinely demonstrate scientific initiative and creativity in research or development activities and maintain a high level of productivity in the lab.
- Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, and GxP compliance, where applicable.
- Bachelors, Masters, or Ph.D. in Analytical Chemistry with 10 to 12 (BS), 8 to 10 (MS), or 0 to 4 (Ph.D.) years peptide-related industry experience.
- Strong technical background in analytical chemistry, excellent analytical problem-solving skills. Capable of independently developing and troubleshoot analytical methods.
- Experience in analytical techniques relevant to peptide product development including mass spectrometry, amino acid analysis, advanced separation techniques, and higher-order structure studies.
- Familiarity with forced degradation, impurity tracking, and stability requirements for peptide products
- Self-motivated, hard-working, detail-oriented individual able to work in a fast-paced team environment.
- High-quality written and oral communication skills and ability to interact effectively with interdisciplinary scientists and engineers.
Preferred:
- Advanced degree in Analytical Chemistry.
- Understanding of cGMP and regulatory requirements.
- Practical knowledge of modern peptide manufacturing processes, organic structure, functional groups, chemistry
- Familiarity with chemical biology fundamentals and related analytical techniques including recombinant protein expression and purification, cell culture, immunoassays, and gels
Key Leadership Competencies:
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
- Demonstrates agility in triaging priorities, pivoting strategy when faced with change, and independently resolving bottlenecks and conflicts
- Highly developed ability to work as part of a team and an effective communicator
- Creates a positive learning environment, open to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures innovation, and manages innovation to reality.
- Actively supports and instructs less experienced colleagues
- A quick learner who is highly motivated to drive for results
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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