Description of Duties and Responsibilities:
Manage and implement laboratory automation programs within the Laboratories R & D organization to support clinical, IND/NDA stability testing, including the oversight of stability program to ensure cGMP compliance.

Specific responsibilities include:
?Manage and implement automation activities to increase the productivity of the laboratory. This may include robotics and other applicable labor saving new technologies.
?Develop and improve existing test methods with goal of increasing ruggedness and efficiency.
?Support the development and implementation of e-Notebook and laboratory data management systems.
?Serve as a technical leader and interface between the stability testing laboratory and the method development group to implement new technologies and resolve technical issues.
?Contribute to the transfer of test methods to affiliates.
?Ensure all aspects of the stability programs are in compliance with current ICH and cGMP requirements.
?Contribute to the preparation of stability reports supporting the CMC portion of Forest's regulatory documents.

Requirements:
?Ph.D. in Analytical Chemistry or a related discipline with at least 5 years of relevant experience or BS/MS with 12-15 years of relevant experience.
?Strong working knowledge of automation technologies and laboratory data systems.
?In-depth understanding of cGMP and relevant ICH guidelines and FDA guidances.
?Excellent oral and written communication skills
?Orientation to detail and a recognition of the importance of training and staff development as a mean of developing and maintaining high level of compliance.

Beth Nacci
Dunhill Professional Search
(860) 444-9057 x208
[email protected]

LRIG Forum

Administrator: Andy Zaayenga, [email protected]

?2002 Laboratory Robotics Interest Group