- This position which is located at Amphastar’s corporate headquarters in Rancho Cucamonga, CA. is responsible for the scientific/technical efforts for physical and chemical characterizations, method development, validation, implementation, testing/reporting, and methods transfer to support the clinical development product pipeline for pharmaceutical drug substances, drug product manufacturing process, product development and regulatory filings. The scope of responsibility spans discovery candidate lead optimization and continuing through pre-clinical, clinical, commercial and life-cycle development programs. This position works collaboratively with the other development functions and contributes to product development plans, timelines and deliverables.
- Providing medical expertise related to the products in the area of responsibility
- Ensures medical/product training for Field Force
- Preparing protocols for GCP trials
- Directly supports the Pipeline and Clinical Operations
- Coordinate organizational resources to support build of data driven study / program assumptions.
- Keeping broad contacts with medical community
- Outstanding written and verbal communication skills.
- Demonstrated team player with the ability to work with little supervision.
- Ability to manage time effectively in a fast-paced, dynamic environment
- Experience functioning in a regulated laboratory environment is also highly desirable.
Desired Skills and Experience
- Degree in medical sciences (Medical Doctor preferred), preferably post-graduated qualifications and/or a Ph.D. in Analytical or Bioanalytical Chemistry or similar scientific discipline
- A broad based experience clinical research, including clinical trial conduct, Knowledge of GCP and a good understanding of the processes associated with study/project management, monitoring, clinical and regulatory operations
- Medical writing skills
- Basic statistical knowledge
- PC literacy
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
Job Type: Full-time
- Rancho Cucamonga, CA (Required)