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LanceSoft, Inc. · 21 hours ago

Biotechnologist Associate

Portsmouth, NH

Contract

Onsite

New Grad, Entry Level

LanceSoft, Inc. is a biotechnology company seeking a Biotechnologist Associate. This role is responsible for the production of therapeutic proteins in a cGMP-regulated environment, supporting manufacturing operations, and ensuring compliance with safety and quality standards.

Information Technology

Growth Opportunities

H1B Sponsor Likely

Hiring Manager

Atul M.

Responsibilities

Manufacture therapeutic protein products (API) under cGMP conditions

Execute manufacturing process recipes and follow written Standard Operating Procedures (SOPs)

Set up, operate, and monitor production equipment and processes, including Clean-In-Place (CIP) and Steam-In-Place (SIP) operations

Monitor production parameters and report results using written and electronic documentation in compliance with GMP and GDP requirements

Perform basic laboratory activities, including:

PH monitoring

Conductivity testing

Sampling and basic product testing

Demonstrate and maintain aseptic technique while handling materials and products

Perform material movements, including transferring raw materials and chemicals into, out of, and across production areas

Maintain facilities and equipment through routine cleaning and sanitization

Support 6S programs and maintain a clean, organized work environment

Willingness to gown and work in a cleanroom environment is required

Maintain accurate production records and review documentation as required

Attain qualification for all assigned tasks and maintain an individual training plan

Develop a working understanding of cGMP compliance while training under close supervision

Attend shift exchanges, meetings, and training sessions

Communicate via email and participate in team projects as assigned

Perform other duties as needed to support manufacturing operations

Qualification

CGMP complianceAseptic techniqueClean-In-Place (CIP)Steam-In-Place (SIP)PH monitoringConductivity testing6S programs

Required

Responsible for the production of therapeutic proteins (API) in a cGMP-regulated manufacturing environment

Execute manufacturing process recipes and follow written Standard Operating Procedures (SOPs)

Set up, operate, and monitor production equipment and processes, including Clean-In-Place (CIP) and Steam-In-Place (SIP) operations

Monitor production parameters and report results using written and electronic documentation in compliance with GMP and GDP requirements

Perform basic laboratory activities, including pH monitoring, conductivity testing, sampling and basic product testing