Sr Scientist, Sterility

About the role

As a Sr Scientist you will be responsible for working with stakeholders from development, clinical, commercial, and manufacturing organizations to develop and test phase-appropriate rapid, alternative microbiology methods (e.g., sterility, mycoplasma, MMV testing) and new technologies related to rapid microbial detection. This is a laboratory-based position and includes, but is not limited to, performing testing to assist in the development and validation of microbiology methods in support of aseptic manufacturing of clinical and commercial drug products, executing assays for technology transfer to commercial sites, and new technology evaluation/implementation.

Responsibilities

• Execution of methods within the laboratory, evaluation and implementation of rapid technologies to facilitate testing
• Providing data to interdisciplinary development teams in support of product development plans
• Additional responsibilities may include the phase appropriate validation of traditional microbiological methods (bioburden and endotoxin)

Qualifications

Sr. Scientist: Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’) OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job. GxP experience in analysis of pharmaceuticals, including analytical or microbiological methods. Effective multi-tasking and oral/written communication skills and be capable of working both independently as well as with the team, driving projects to completion with management oversight. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Working Environment

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
• Able to work upright and stationary and/or standing for typical working hours
• Able to lift and move objects up to 25 pounds
• Able to work in non-traditional work environments
• Able to use and learn standard office equipment and technology with proficiency