CAMRIS International is a medical research and development firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective program and research management services. We combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research. This position will support the Pilot Bio-Production Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.
* Plan and conduct analytical tests for drug development and transfer the methods to CDMO
* Analyze and interpret data and prepare technical reports
* Perform IQ/OQ/PQ and maintain lab equipment
* Follow safety procedures and good laboratory practice
* Monitor and coordinate starting materials, drug substance and drug product testing activities conducted at the PBF
* Oversee method development for drug substance and drug product. Ensure methods are suitable, sufficient and development phase appropriate.
* Participate in method validation activities: review analytical methods, validation protocols and reports at the PBF
* Coordinate and manage analytical method transfers
* Review analytical results and supporting documentation to ensure quality standards are met for release and stability testing of starting materials, drug substance and drug product
* Analyze, monitor and trend stability data for starting materials, drug substance and drug product
* Support analytical characterization activities (i.e. identification of new degradants).
* Draft and monitor project plans and timelines
* Manage and coordinate reference standard supplies
* Collaborate with the Quality Assurance department to ensure compliance
* Reviews as required various technology transfer documentation with regulatory and other appropriate groups Other related duties as assigned
* BS/MS with 10-12+ years of pharma industry analytical experience working within analytical development/validation
* Excellent method development and validation skills and routine analysis.
* Ability to directly or indirectly manage small teams.
* Strong preference for an analytical scientist who has used a variety of analytical techniques/instrumentation
* Strong preference for an analytical scientist who either has worked within a contract analytical lab working with external clients or has worked within a pharma company who outsourced some analytical work to external CDMOs.
* Ability to self-manage and take on new tasks
* Ability to learn new analytical techniques by hands-on work and review of published data
* Ability to multi-task and hit project timelines.
* Excellent oral and written communication skills