Duration : 6 months

Primary Duties

? Execute routine in-process, drug substance, and stability test methods.

? Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower).

? Maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal).

Education and Experience Requirements:

? Include educational requirements or equivalency, required years and type(s) or experience, and necessary licenses or certificates. Specify which are required and which are preferred.

? Bachelor’s or master’s degree in any Life Sciences with relevant laboratory coursework.

? 0-3 years of relevant experience.

? Previous experience in a regulated environment preferred.

? Laboratory instrumentation understanding or experience preferred.

? Must be able to communicate effectively with managers and peers.

? Must be able to read, write, and converse in English.

? Must have basic computer skills. General use of word processing, spreadsheets, databases, etc. for the purposes of work execution, training, performance management, and self-service. Good interpersonal skills and able to work effectively and efficiently in a team environment.

? Knowledge of cGMP manufacturing preferred.

? Knowledge of basic chemical, biological and/or microbiological safety procedures preferred.

? Must display eagerness to learn and continuously improve.

Key Skills, Abilities, and Competencies:

Describe critical skill and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Additional preferred skills include, but are not limited to:

? QC Analytical Skill Set – HPLC, UPLC, UV-Vis, Appearance, Concentration, pH, CE, Osmolality, TOC, strong micropipetting skills

? QC Bioassay Skill Set – ELISA’s, Cell Maintenance, Cell-Based Assays, plate readers, Gels, icIEF, Aseptic Technique, strong micropipetting skills, biosafety cabinets

? QC Micro Skill Set – Endotoxin, Bioburden, Environmental Monitoring, Manufacturing Cleanrooms, Aseptic Technique, Critical Utility systems Complexity and Problem Solving

Describe the decisions made by the incumbents on a regular basis. Include decisions within the Incumbent’s authority to make as well as those decisions that must be referred to a higher level.

? Employee at this level is involved in routine tasks of basic scope and complexity.

? Employee receives detailed instructions on new work and refers to policies and procedures for guidance.

? Responsible for conducting independent work with guidance from trainers and more senior staff.

? Responsible for making basic decisions founded on sound principles, international industry/regulatory standards, and robust scientific basis.

? Understand the needs of key collaborators (i.e., Quality and Manufacturing Operations) to provide compliant and timely test results.