Manufacturing Technician (Downstream)

Job Description:

The Downstream Manufacturing Technician will actively contribute to the manufacturing and technology transfer projects. As part of the Purification/Manufacturing group, you will have opportunities to work on a wide-ranging set of projects for troubleshooting and investigations, system and workflow implementation, and tech transfers of processes into the GMP manufacturing facility. The role will provide hands-on execution of complex experiments in a team setting. The role will support GMP readiness and manufacturing activities. The scope of responsibilities may include but are not limited to Document writing (SOPs, Equipment URSs, etc.), equipment validation execution support and single-use assembly design.

• Execute, with oversight of qualified staff, complex unit operations including but not limited to chromatography, TFF, depth filtration, virus filtration, and buffer preparation in GMP manufacturing suites.
• Maintain own training within compliance.
• Support in equipment troubleshooting, pilot scale material generation, non-GMP tox material generation and GMP downstream manufacturing activities.
• Author/review/approve technical documents such as tech transfer protocols and reports, production batch records, training materials, manufacturing SOPs, and regulatory filing documents per project needs.

Qualifications:

• BS in Life Sciences, or related discipline with 0~1 years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.
• Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing, preferable
• Working knowledge of industry-standard purification processes (affinity, IEX, SEC, viral inactivation and filtration, depth filtration, TFF, UFDF, etc) and equipment (GE AKTAs, disposables), preferrable
• Experience with process monitoring software and equipment software (UNICORN, Pi Historian)
• Creative thinker that can identify better and more efficient methods to address issues and gaps
• Demonstrate ability to work independently and on cross-functional teams
• Ability to prioritize assignments and to manage multiple projects simultaneously.