Business Title: Biopharm Manufacturing Associate

Location: Cambridge, MA

Job Type: 12 Months contract

***PARKING IS ROUGHLY $420/MO***

We’re seeking a motivated individual capable of performing manufacturing processes following current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) within a cleanroom environment. Reporting to the department manager and working on a shift of 12 individuals, the individual will be expected to demonstrate expertise and breadth of knowledge in operating automated systems, setting up and using single use pharmaceutical systems (mixing, filtration, homogenization), following written procedures (SOPs), performing in process testing (pH, conductivity testing, weighing), and conducting routine sanitization tasks to maintain facility and equipment in a clean controlled state.

Job Responsibilities

• Assist with set-up and operates new complex processing equipment
• Identify and propose solutions to complex problems
• Act in a leading and/or SME capacity for equipment / process operations and may perform supervisory role in the absence of immediate supervisor
• May assist with recruiting activities
• May interact with outside agency inspectors
• Demonstrates independent project management
• Drafts, revises, reviews and may own complex documents (i.e. Batch Records, Form Preps)

Skills & Experience Required

• Bachelor's degree in relevant field
• 2 years’ experience in GMP manufacturing production
• Basic knowledge of CFRs and regulatory trends
• More advanced knowledge / proficiency with business software (i.e. Excel, Visio) and industry systems (LIMS, ERP)