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As a process development chemist in the chemical development department of Agilent Technologies Nucleic Acid Solutions Division the candidate will be responsible for multiple aspects of process development and process transfer that supports Active Pharmaceutical Ingredient (API) manufacturing.
Essential duties and responsibilities include but are not limited to:
• Understand synthetic chemistry, particularly oligonucleotide or similar type molecule, study and implement solutions that support project objectives during clinical development.
• Contribute knowledge and ideas to the development of synthetic routes, methods and techniques in synthesizing, purifying, identification and control of impurities,
• Contribute knowledge and ideas for process optimization, scale-up and laboratory process transfer to mid and kilo scale GMP manufacturing.
• Design and conduct laboratory scale experiments in a safe and effective manner including solid-phase synthesis, reverse phase or ion chromatography, ultrafiltration techniques, analysis of reactions via HPLC and HPLC/MS.
• Properly record and summarize experiments in notebooks and reports and construct research summaries to present to internal and external teams.
• Operate laboratory equipment by following operating instructions; troubleshooting instrumentation and method issues.
• Assist with the preparation of milligram to gram quantities of active pharmaceutical ingredient (API) to support early stage (pre-clinical) development and toxicology studies.
• Maintain process compliance integrity by adhering to standard operating procedures (SOP's) and current good manufacturing practices (cGMP) as appropriate.
• Bachelor's degree (B. S.) or equivalent in chemistry, or related applied sciences field
• 2+ years of relevant experience and/or training; or equivalent combination of education and experience.
• Knowledge of techniques for development and transfer of safe, robust and scalable processes for the preparation of APIs.
• Experience and knowledge at process development or process optimization of oligonucleotide and/or peptide classes of active pharmaceutical ingredients is highly preferred
• Experience and knowledge at process transfer of into GMP manufacturing settings
• Experience and knowledge at non-GMP or GMP manufacture of oligonucleotide and/or peptide classes
• Ability to read, analyze, and understand common scientific and technical journals, reports, and procedures. Respond to common inquiries or complaints and effectively present information to customers, co-workers, or members of management
• Ability to work with interdisciplinary project teams to understand project requirements, follow project timelines, and help develop technical solutions to ensure that API processes are successfully demonstrated and transferred
• Ability to Satisfactorily complete all GMP and safety training in conformance with Agilent requirements. Ensure the compliance with all site and departmental safety policies.
• Ability to assist in the development of experimental and processing concepts for methods and applications to meet process and client objectives
• Ability to use and skillfully operate laboratory equipment.
• Knowledge of and skill in using computer software and hardware applications, including Microsoft products and the Internet.
• Knowledge of and skill in establishing and applying Standard Operating Procedures in a GMP environment.
Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.
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