Manufacturing Associate/Senior Manufacturing Associate
AntriaBio is a biopharmaceutical company that develops novel extended release therapies by combining proprietary formulation and manufacturing capabilities with well-known molecules to significantly improve standards of care. AntriaBio's lead product candidate is AB101, an injectable once-weekly basal insulin for Type 1 and Type 2 diabetes that addresses a $11 billion market where the current standard of care is a once-daily basal insulin injection.
Summary: The ideal candidate will provide expertise in translating aseptic processing experience into a growing cGMP microsphere production, API production, and fill/finish environment. Candidate will have a firm grasp on cGMP production requirements and expectations. Success in this role depends on ability to multi-task while remaining focused, willingness to be challenged, ability to remain flexible, embracing a team-based collaborative mindset, and consistently execute established processes.
- Successfully produce sterile microsphere formulations under cGMP practices.
- Manufacture API in support of microsphere production.
- Perform aseptic fill/finish activities in an ISO 5 environment.
- Develop a comprehensive operational knowledge of all systems required by the process.
- Ability to follow procedures (eg. SOP’s, batch records, training materials) clearly and concisely.
- Stringent and rigorous attention to detail with GMP documentation.
- Troubleshoot issues and optimize processes in order to ensure cGMP compliance.
- Take an active role in the production process and suites through the cleaning, sterilization, and operation of vessels and systems supporting API and Microsphere production.
- Perform buffer and solution preparations, as needed.
- Execute commissioning tasks such as IQ/OQ/PQ.
- Execute preventive maintenance tasks on equipment as assigned.
- Ability to own project sub-tasks and initiatives supporting operational-critical objectives.
- Author production documentation and change controls, as necessary.
- Review executed GMP documentation.
Experience and Required Skills:
- Must possess good interpersonal, communication, and team skills.
- Have a strong focus on quality and attention to detail.
- Be a proven team player and exude a collaborative spirit, yet still be able to work autonomously as needed.
- Embrace the systems-based rigor required for cGMP processing.
- Must be a motivated self-starter with a mechanical aptitude.
- Familiarity with chromatography, tangential flow filtration, pegylation, lyophilization, autoclaving, and emulsion processes is desirable.
- Experience in aseptic processing (SIP, sampling, autoclaving, cleanroom operations) preferred.
- Experience in fill/finish and ISO 5 operations is a tremendous advantage.
- 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.
BS/MS in Biological Sciences or Engineering disciplines preferred, or 4+ years of demonstrated success working in a GLP, GMP, or other regulated manufacturing environment.