AntriaBio is a clinical stage biopharmaceutical company specializing in the development of innovative drug therapies to improve the lives of patients with diabetes and metabolic diseases. AntriaBio's lead product candidate is AB101, an injectable once-weekly basal insulin for Type 1 and Type 2 diabetes that addresses an $11 billion market where the current standard of care is a once-daily basal insulin injection.
Summary: This position is required to have sufficient experience to be the primary owner of AntriaBio’s internal equipment cleaning program, as well as provide on-the-floor support to the Operations Team. The employee must be highly-organized, detailed, energetic, a problem solver, a quick study, and possess the ability to assist with commissioning work.
- Own and execute the cleaning/disinfecting program for processing equipment—in both ISO 7 and ISO 5 production areas.
- Own the cleaning/disinfecting controlled documents, including executable forms and SOPs, and provide necessary training internally and to contractors.
- Execute critical operations support functions (e.g. filter integrity testing, autoclave preparation and operation, stocking of gowning rooms, stocking of cleaning supplies, disposal and testing of waste streams).
- CIP/COP execution in support of operations.
- Assist in SIP operations.
- Perform buffer and solution preparations, as needed.
- Execute preventive maintenance tasks on equipment as assigned.
- Assist with commissioning tasks such as IQ/OQ/PQ.
- Assist in the proper management and disposal of hazardous wastes
- Other duties as applicable to ensure operational success.
Experience and Required Skills:
- Ability to follow procedures (eg. SOP’s, MBR’s, training materials) clearly and concisely.
- Must possess good interpersonal, communication, and team skills.
- Understand the interconnectedness of the cleaning program to production schedules, and impacts arising from disconnects.
- Have a strong focus on quality and attention to detail.
- Be a proven team player and exude a collaborative spirit, yet maintain focus and drive while working autonomously.
- Embrace the systems-based rigor required for cGMP processing.
- Must be a motivated self-starter with a mechanical aptitude.
- Ability to work overtime or shift work as assigned.
- Ability to thrive in the ambiguity and shifting priorities consistent with a start-up environment.
- Must be able to lift 40 pounds and stand for extended periods of time, handle chemicals including industrial-scale solvents, acids and bases, and wear special gowning and follow protective procedures in some areas.
AA, AS or BS in Biological Sciences or Engineering disciplines preferred, or 2+ years in related work experience in a GLP, GMP, or other regulated manufacturing environment.