Job Details

Overview

Responsible for Technology Transfer and process scale up activities associated with parenteral drug products. Supports cross-functional Production, Engineering, Quality Assurance, and Validation departments to support the trouble shooting of manufacturing issues.

Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Design and Execute experiments for Tech Transfer, Process R&D/Scale up/Validation, and other activities needed to introduce a new product and/or exiting products into a cGMP manufacturing site.
• Work with Production, Engineering, Quality Assurance, and Validation departments for equipment qualification, process scale up, optimization, and validation.
• Co-ordinate with CMOs for the external Technology Transfers (If required)
• Work with R&D project leads and develop a robust technology transfer processes from lab scale to manufacturing site.
• Design co-ordinate, execute laboratory experiments to study material compatibility
• Draft the Engineering Protocols, Technology Transfer reports, and Master Batch Records.
• Generate the documents in support of regulatory submissions.
• Ensure all work is performed and documented in accordance with existing company policies, procedures, current Good Manufacturing Practices, and health and safety requirements.
• Perform any other tasks/duties as assigned by management.

Education Requirements And Qualifications

• Bachelor's Degree with 4-6 years progressive work experience in Technical Services encompassing Tech Transfer, Technical Trouble shooting, and process optimization, required.
• Master's Degree in Chemical Engineering or Pharmaceutical Chemistry with 2-3 years' experience, preferred.
• Broad knowledge of Process development and scale up of sterile injectable products is essential.
• “Outside the box thinking” and Collaborative mindset is required
• Hands on skills in Laboratory instruments such as particle sizer, HPLC, Karl Fisher, DSC, etc.
• Knowledge of pharmaceutical lifecycle management is a plus.
• Excellent organizational, interpersonal and communication skills are required.
• Proficiency in Microsoft Office Word and Excel is required.

Physical Environment And Requirements

• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
• Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.
• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
• Position requires working in the laboratory as well as sitting.