The Bioprocessing Manufacturing Technician will be responsible for supporting cGMP manufacturing processes while adhering to Standard Operating Procedures (SOPs) and regulatory guidelines in a controlled cleanroom environment. The ideal candidate must have a strong attention to detail, excellent customer service skills, and the ability to work well and collaborate in cross-functional teams.

Key Responsibilities

• Support daily manufacturing responsibilities for clinical and commercial manufacturing programs
  

• Execute and document batch records in compliance with current Good Documentation Practices
  

• Revise and review SOPs, batch records, and other documentation to support manufacturing
  

• Support microbial fermentation and/or Mammalian cell culture in Upstream/Downstream processing, including:
  

  • Upstream: Bacterial fermentation and Mammalian single-use systems up to 1000L, continuous flow centrifuges, homogenization and depth filtration operations, single-use temperature-controlled mixing systems
    

  • Downstream: Bench-scale to Large-scale filtration systems (including TFF and depth filtration), bench-scale to Large-scale Chromatographic AKTA and HPLC systems, packing and evaluating columns, drug substance bulk fill or vial fill and aseptic handling techniques
    

  
  

• Support deviation and CAPA resolution with SME and quality teams
  

• Provide input and support to MSAT/PD during development and scale-up activities as necessary
  

• Support facilities in ensuring proper functionality of equipment calibration and preventative maintenance as part of the equipment control program
  

• Maintain company and client confidentiality
  

• Communicate safety policies and goals and ensure team members adhere to facility safety policies

Qualifications

• Associate’s, BS, or MS degree from an accredited college or university with major coursework in a Scientific or Engineering discipline
  

• Experience working in a GMP manufacturing environment is essential
  

• Experience with microbial systems is highly desirable
  

• 4+ years of AS/BS or 3+ years of MS of biomanufacturing experience
  

• Strong background in cGMP principles and Quality Management Systems
  

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Knowledge and Skills

• Excellent verbal and written communication skills; strong presentation skills
  

• Analytical ability, both interpersonal and issue-related; good judgment and ethics; professional presence and demeanor  
  

• Proficiency in Microsoft Word, Excel, PowerPoint, and Project
  

• Working knowledge of commercial cGMPs and phase-appropriate cGMPs as they apply to various phases of clinical and commercial manufacturing
  

• Working knowledge of current global regulatory requirements and guidelines
  

• Ability to perform within all Standard Operating Procedures (SOPs) and policies

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