JOB SUMMARY:

Working under direct supervision, the Manufacturing Associate/Research Associate II performs routine and increasingly complex laboratory tasks and procedures and develops technical expertise in one or more areas relevant to research projects. The Research Associate II will participate in research activities involving all aspects of the research process, to include, but not limited to; investigation, technical, testing/validation of results, and report findings. The Associate will perform a variety of routine experimental protocols and procedures to support the objectives of laboratory research projects. The Associate will observe and comply with safety standards and procedures, assist in preparation of data for publication and/or presentation at scholarly meetings, and assist in general laboratory maintenance. This position does not have supervisory responsibilities.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

• Conducting routine manufacturing of biologic products including media preparation, cell culture, cell counting, formulation, centrifugation and freezing Independently completing required documentation and guiding other operators on proper cGMP recording of entries and comments on batch records, forms and protocols
• Performs a variety of increasingly complex experimental protocols and procedures and assist in the design of new complex or unusual protocols and techniques.
• Keeps accurate and detailed records of experiments and results, and assist in identifying and troubleshooting of unexpected results.
• Preparing technical summaries, protocols and reports
• Orders laboratory supplies and supports laboratory operations.
• Maintains lab equipment and related records and may coordinate use of lab equipment.
• Assists in the operation of specialized equipment, as required by the area of research.
• Assists in preparation of data for publication and/or presentation at scholarly meetings.
• Observes and complies with safety standards and procedures.
• Orients research laboratory assistants or lower level research associates and undergraduate student researchers on day-to-day lab operations and routine procedures.

• Bachelor’s degree in Biomedical Engineering, Biological Sciences or related field
• Two (2) years of laboratory experience.
• 1-3 years of experience in cGMP/cGTP manufacturing environment in academic/industry setting.
• Individuals with a scientific background, mammalian cell culture and cGMP experience needed.
• Working knowledge of the regulatory requirements (cGMP/cGTP) in the biopharmaceutical, blood and/or tissue banking industry.
• Understanding of general research objectives.
• Familiar with routine laboratory procedures, experimental protocols, and overall lab organization.
• Applicant must be highly motivated and able to work independently.
• Must have superior interpersonal, communication and organization skills and the ability to work across company disciplines and functional units, and computer application experience.
• Must possess computer skills to include, but not limited to, Excel and Word.
• Ability to simultaneously manage multiple clerical trials, and attention to details.