Scientist-Analytical Development, Quality Control
This Bioscience company is engaged in pioneering activities with pharmacotherapies affecting the human microbiome, including the Gemicel® drug delivery platform. The selected candidate will be tasked with performing hands-on laboratory work in the development and execution of analytical methodologies in support of process development, characterization activities, specification, and stability testing. It is expected that the individual will work closely with Process Development teams to execute testing activities, as well as authorship of technical protocols and reports, as applicable. Experience in hands-on method development activities, execution and troubleshooting of existing methods are key requirements for this role. Specific proficiency with Karl Fischer, dissolution/disintegration, and/or qPCR is highly beneficial, and experience with other microbiological testing such as microscopy, flow cytometry, and general spectrophotometric techniques is highly desired. Additionally, the successful candidate will be expected to function independently with minimal supervision. Knowledge of good documentation practices and an attention to detail are also expected of the incumbent.
This is a contract position currently through the end of 2018; extension possible depending on company needs.
- Participate in operations for in-house analytical development and testing capabilities
- Participate on cross-functional teams relating to process development
- Develop robust and reproducible analytical methodologies for evaluation of product quality attributes and characterization studies
- Support OOS, root cause, and CAPA investigations, including execution of troubleshooting activities, as necessary
- Execute analytical testing and author technical documents
- Motivated self-starter who can work independently with minimal supervision
- Excellent professional and interpersonal skills
- Excellent oral and written communication skills
- Ability to work efficiently and cooperatively in a virtual company environment
- Goal oriented and ability to deliver on timelines and commitments
- Exhibits a proactive, transparent, and rigorously objective confidence in all aspects of analytical development/quality control activities
- Education in Microbiology, Chemistry or a related discipline, experience in Biotech/Pharma industry with hands-on background and directly relevant experience with microbiological/biologic testing. Position level and compensation will depend on education and experience
- Specific experience with anaerobic cultures is highly desirable
- Hands-on experience with applicable analytical instrumentation, including the ability to set-up, operate, and troubleshoot equipment
- Demonstrated ability to independently write technical reports
- Knowledge of cGMPs
Includes Medical Benefits, 401K and Sick time.