Oversee and lead a group of 6-10 employees in the Analytical Development lab
The candidate must have a minimum of 12 years experience in a
management role with strong client service and people skills.
The candidate must have good communication skills, both written and verbal and be able to manage many tasks in a fast paced environment.
- Plans and directs all activities in analytical development laboratory and execute those activities smoothly
- Assists the director to track and monitor the department budget (operational expenses, capital expenses and head counts) according to the agreed budget
- Hires and trains Analytical Development staff to serve our clients. Ensures Analytical Development department is in compliance with cGLP and cGMP
- Leads analytical discussions with clients for all clients' analytical projects
- Provides internal and external technical support for methods development, transfer and validation, etc activities.
- Responsible for scientific proposals, procedures and reports
- Works closely with other functional areas such as Project Management, Quality Control, Quality Assurance and Commercial Manufacturing as well as with clients to meet the timelines and requirements
- Participates in research and development activities and is accountable for preparation of all technical documents to support our clients' submissions for INDs, NDAs, and ANDAs, etc
- Writes analytical protocols, analytical testing procedures, and pharmaceutical development reports, etc
- A minimum of an M.Sc. in analytical or pharmaceutical related field.
- 10 years experience in the area of analytical development, pharmaceutical and contract services laboratory with 6+ years of supervisory role
- Experience with FDA, EMA and other regulatory inspections etc.
HALO Pharmaceutical Inc. - 2 years ago