PDM Assistant

DESIRED QUALIFICATIONS:

·       Knowledge and following SOPs and batch records preferred

·       Aseptic technique experiences desired

·       Experience with cell therapy manufacturing desired

·       cGMP experience is preferred

·       Gene Therapy using CRISPR Cas9 preferred

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree in related scientific field or an equivalent combination of education and experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

·       Strong understanding of biological scientific principles

·       Strong computer skills and ability to learn quickly and master computer programs, databases and scientific applications

·       Ability to work under deadlines with minimal supervision

·       Ability to maintain relationships and communicate effectively

·       Excellent organizational skills and demonstrated ability to complete detailed work.

·       Maintain knowledge of cGMP environment requirements.

CERTIFICATIONS & LICENSES:

None

PHYSICAL REQUIREMENTS*:

·       Frequently sit, grasp lightly, use fine hand manipulation, repetitive pipetting, perform desk-based computer tasks, and lift, carry, push, and pull objects up to 35 pounds.

*- Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:

·       May require working in close proximity to blood borne pathogens.

·       Ability to work with unpredictable manufacturing schedules.

·       Position may at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present.

·       Position primarily requires working in a cGMP clean room environment.

·       Position may work with viruses: lentiviruses, adeno-associated viruses, and/or retroviruses.

·       Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves.

·       May be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA, Allergens/Biohazards/ Chemicals, and confined spaces.

May require extended or unusual work hours based on clinical manufacturing requirements and business needs. May be required to stay at work until product is released.