Biopharm Manufacturing Associate

Alphanumeric is hiring a BIOPHARM MANUFACTURING ASSOCIATE to work in Cambridge, MA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.

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.

Key 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)
  
  

Basic Qualifications

• We are looking for professionals with these required skills to achieve our goals:
• Bachelor's degree with 2+ years' experience in GMP manufacturing production
• OR, HS Diploma or GED with 3+ years' experience in GMP manufacturing production
  
  

Preferred Qualifications

• If you have the following characteristics, it would be a plus:
• Facilitation and demonstration skills
• Basic knowledge of CFRs and regulatory trends
• Independent collaboration with outside resources
• More advanced knowledge / proficiency with business software (i.e. Excel, Visio) and industry systems (LIMS, ERP)
  
  

Top Requirements

• Must have 2-3 years of experience
• Must have TFF experience
  
  

About Alphanumeric Systems Inc.

Alphanumeric is a dynamic company born of a diverse mindset and held to a distinctly high standard. You may know us as a tech and communications firm established in 1979, but we also lead life science and healthcare organizations toward a more efficient future across the globe, bringing patients and providers together to build personalized relationships that fit their needs.But at our core, we are a family with a shared and passionate dedication to our customers. We treat our candidates as amazing (because they are!)Apply today to join our family and Make Your Mark!