POSITION OBJECTIVE: The CMC Technical Project Coordinator will be responsible for coordinating CMC project teams, review and organize CMC data, and to support regulatory filings. This position will also be responsible for managing project timelines, submission status and overall administrative coordination among the CMC department.
Essential Job Functions
· Coordinates project teams, maintains project timelines, tracks adherence to objectives, budgets and timeline.
· Organizes and schedules interdisciplinary project meetings.
· Reviews manufacturing batch records, stability reports, protocols, and deviations/investigations from CMO vendors.
· Receives, organizes, and appropriately disseminates information from incoming reports and GMP documentation related to drug product manufacturing.
· Ensures proper storage and recovery to maintain data integrity.
· Summarizes data and reports in written and oral presentations.
· Supports product investigations and deviations through completion of Quality review.
· Works with the CMC team to provide manufacturing data in appropriate formats for regulatory filings; provides review of FDA documentation prior to final submission.
· Develops and maintains relationships with project managers at outsourcing facilities to collect information relevant to the manufacture of Athenex drug products.
· Works as an effective team member to meet departmental objectives, sharing knowledge with CMC team members
· Assists in writing of department policies and procedures
· Promotes and exemplifies the Athenex culture, maintaining a high standard of quality.
Required Education & Qualifications
· Bachelor’s degree in chemistry, biology, or pharmacy field
· 0-2 years of experience in a pharmaceutical or drug discovery environment
· Preferred experience with GMP documentation
· Highly organized and proficient with Microsoft Excel and Word and Microsoft Project desirable.
- Strong ability to collaborate and build strategic relationships with internal (clinical operations, quality, etc.) as well as external (CMO, CRO, etc.) stakeholders.
· Able to communicate in a professional manner and interact with multiple departments on a daily basis
· Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
- Ability to multi-task and shift priorities appropriately in a dynamic, fast paced work environment
- Strong analytical and organizational skills – Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.