职位描述
Function of the Position:
As a member of the Analytical Sciences group, the successful candidate will play a leading role on new and ongoing analytical procedure development for USP Medicine Compendium programs.
Interpret observations/results, and present data in scientific meeting /management meeting internally/externally.
Roles and Responsibilities:
· Lead analytical procedure development for characterization and testing of drug substances, excipients and drug product. Conduct analytical procedure validation according to pre-approved protocol.
· Provide technical expertise in planning, monitoring, and maintaining project timelines to meet business needs.
· Present the results of your work internally and externally, and write reports that will be submitted to USP expert committee. Conduct all activities in compliance with established regulatory requirements. Assist in the development of protocols to conduct studies in conjunction with others to meet requirements.
· Understand and comply with Safety, Good Laboratory Practice/Good Manufacture Practices (GLP/GMP), and Standard Operating Procedures (SOP) and Policies.
· Record, evaluate, interpret and summarize technical data. Develop and validate calculation procedures. Document activities in technical notebooks or validated approved electronic media. Design experiments and prepare reports, memos or documents with little direct guidance.
· Maximize innovation by utilizing original concepts and creative thinking.
· Can shift priorities and projects as organization needs change. As needed, assist others as priorities change. Observe safety rules and works safely in the laboratory.
· Plan and track analytical development objectives, timelines, priorities, and resources
· Mentorship and management of internal analytical scientists
Frequent Contacts:
USP scientific liaison
Reference Standards Evaluation Staff
Documentary Standards Division Staff
Quality Assurance Staff
Applied Compendial Research Division Staff
Minimum Requirements:
Ph.D. with at least 2 years in chemistry, analytical chemistry, pharmacy or related field, Master degree with at least 5 years of relevant experiences.
KSAs and Training and Experience:
Practical knowledge of chemical principles, theories, and practices, and a working knowledge of common analytical procedures, including skill in calibrating and operating analytical instruments such as spectrophotometers and chromatography equipment. Experience in pharmaceutical and/or biotechnology industry preferred.
Takes personal responsibility to ensure work is delivered on time and is the highest possible quality.
Strong communication and presentation skills, both verbal and written in English.
Strong chromatography knowledge with depth of practical experience on analytical techniques such as HPLC, LC-MS, IC, and GC, GC-MS Experience in xcipient analysis is highly preferred.
A good knowledge of GLP/cGMP regulations , ICH/VICH guidelines, and compendial methods. Incumbent must possess detailed knowledge of separation sciences and modern analytical instruments, and must be able to work with others to accomplish project goals.
Must have strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment.
Supervisory Requirements: Experiences in project management would be preferred.
