Process Development & Manufacturing Specialist-Vector

DESIRED QUALIFICATIONS:

·       Knowledge and following SOPs and batch records preferred

·       Aseptic technique and cell culture experience preferred

·       Experience with viral vector production, molecular biology, upstream and downstream processing preferred

·       Experience with chromatography and Stirtrd tank (STR) or Wave bioreactors.

·       cGMP experience is preferred

·       Ability to occasionally work into the evening and/or on weekends, depending on clinical manufacturing schedules

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree in related scientific field and two years of related experience, or Master’s degree, or an equivalent combination of education and relevant work experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

·       Strong biological scientific background

·       Working experience with aseptic cell culture

·       cGMP clean room experience

·       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.

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 20 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 under deadlines and meet/ exceed 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 requires working in a cGMP clean room environment.

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

·       Position may work with human embryonic stem cells (hESCs).

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

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

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