Manufacturing Intern — Gene Therapy GMP Ops

Ultragenyx; Bedford (MA); In loco; USD 34.000 - 41.000; Tempo pieno

Descrizione del lavoro

Ultragenyx in Bedford, MA is seeking Manufacturing Associates to support state-of-the-art GMP manufacturing for gene therapy. The role involves downstream and central services, creating SOPs and batch records, and maintaining a compliant, efficient production area.

Candidates should be detail-oriented, able to work on a fast-paced startup environment, with 1–2 years in a regulated industry preferred, and proficiency in Microsoft Office. The shift is Tuesday–Friday, 6am–4:30pm, on site.

Competenze

• High school degree to BS in any field; enrollment in Biotech Certificate Program.
• Preferably 1–2 years in a regulated industry.
• Ability to read, understand, and follow procedures; proficient in Microsoft Office.
• Able to work in a fast-paced, startup environment with strong collaboration.
• Detail-oriented and independently motivated; knowledge of cGMPs is a plus.

Mansioni

• Attend daily manufacturing tier 1 meetings and communicate operation status.
• Generate, review, and approve SOPs, batch records, and protocols for Downstream and Central Services.
• Support quality investigations and continuous improvement tied to manufacturing areas.
• Maintain facility organization and uptime in Downstream/Central Services.
• Follow environmental health and safety and cGMP requirements.

Conoscenze

Teamwork

Communication skills

Attention to detail

Self-motivation

MS Office proficiency

Ability to read procedures

Formazione

High school to BS in any field

Biotech certificate program enrollment

Strumenti

Filtration techniques

Tangential flow filtration

Column chromatography

Aseptic technique

Descrizione del lavoro

Ultragenyx in Bedford, MA is seeking Manufacturing Associates to support state-of-the-art GMP manufacturing for gene therapy. The role involves downstream and central services, creating SOPs and batch records, and maintaining a compliant, efficient production area.

Candidates should be detail-oriented, able to work on a fast-paced startup environment, with 1–2 years in a regulated industry preferred, and proficiency in Microsoft Office. The shift is Tuesday–Friday, 6am–4:30pm, on site.