Technical Director – Chemistry
Brief Job Summary:
The Technical Director is responsible for providing customer support and technical guidance for extractable/leachable and related programs for container closures, delivery systems and disposables for biologics and pharmaceutical applications
- Uses knowledge of industry standards including FDA and ICH guidance to provide to provide strategic direction as well as technical support to staff.
- Interacts with client to discuss project planning and testing requirements.
- Interacts with internal staff and management to identify assay requiring further improvements or development and oversees improvement of these assays.
- Facilitate communication between members of the study team and sponsor.
- Follow up with clients as needed.
- Interaction with internal and external clients and laboratories.
- Develop and maintain protocols.
Position Specific Responsibilities:
- Attend conference calls and write project proposals.
- Dedicated management of clients.
- Work with multiple internal and external laboratories to ensure accurate and on-time project completion.
- Receive and review reports to ensure accuracy, consistency and professional appearance.
- Detail Orientated with Strong Organizational skills
- Proficient in Microsoft Word, Excel and Windows based programs
- GLP/GMP Experience, experience as GLP Study Director a plus.
- Strong Understanding of Biologics development and submission requirements.
- Basic Understanding or previous experience analytical techniques with LCMS, GCMS and/or ICPMS preferred
- Outstanding customer service, organizational and analytical program/project management skills
- Bachelors Degree or equivalent life science or Biotech experience.
- Minimum of 10 years of experience
To apply please click on this link:https://home.eease.adp.com/recruit/?id=10082291