This position will be responsible for conducting testing of samples in support of process development, characterization, developmental stability, validation and other R&D projects. Other responsibilities include cGMP documentation, sample login, data review, instrument maintenance, and other tasks assigned by management. The analyst may participate in development, execution, and qualification of new analytical test methods for characterization. The incumbent will be expected to work effectively under general supervision and contribute to the team effort to support R&D projects.
Job Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
The individual will perform technically diverse testing and analysis with minimal assistance using modern instrumental analytical techniques including but not limited to coagulation assays, enzymatic assays, immunoassays, chromatography (HPLC, GC, IC), capillary electrophoresis, and gel electrophoresis.
The candidate will perform accurate technical/cGXP review of other operators work and can interpret /understand trends in data.
The candidate will contribute to report writing and perform data analysis.
The individual will also assist in coordination of specific activities such as method qualification execution, IOQ execution and small study execution. The candidate must have strong scientific understanding of the test methods being performed as well as the products/intermediates being tested.
Excellent verbal and written communication skills.
Self-starter with strong work ethic and the ability to exercise good judgment.
Ability to work independently with minimum supervision.
Must be proactive, results oriented, and have strong attention to detail.
Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Teams).
The candidate must be able to recognize aberrant results and will be responsible for initiating investigations when necessary. He or she will participate in moderate to extensive problem solving which requires original thought and must effectively interact with scientific and non-scientific personnel.
The candidate must be able to recognize when to modify a standard approach to be more effective and incorporates new technology when appropriate. Frequent communication with personnel from other departments is often necessary to fulfill project assignments.
Requirements:
Experience:
Use of modern instrumental analytical techniques including but not limited to coagulation assays, enzymatic assays, immunoassays, chromatography (HPLC, GC, IC), capillary electrophoresis, and gel electrophoresis.
Education: Biology, Biochemistry, Chemistry, or Toxicology
Masters plus 1 year of relevant experience, or Bachelors plus 3-4 years of relevant experience
No degree requires 7 years of relevant experience. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.