Process Transfer Coordinator II (Avecia: Milford, MA, Massachusetts, US) en Nitto Denko Corporation

About this opportunity :

In this role, you will manage technology transfer activities for the manufacture of oligonucleotide active pharmaceutical ingredients.  

Key Responsibilities: 

• Lead and manage all Technology Transfer technical aspects for oligonucleotide projects from process development to oligo manufacturing, Oligo™ Platform approach manufactures, and any cross-site technology or process transfers  
• Evaluate, document and review oligonucleotide compounds physical attribute and modality for occupational exposure banding (OEB), and facility risk including cleaning and carryover. 
• Interpret development plans, external tech transfer documents, or master batch records to generate accurate forecasts for GMP raw material needs.  
• Prepare and maintain enterprise resource planning (SAP) inputs for all active GMP manufactures, executed or upcoming. 
• Lead and manage the interface between Supply Chain (SC), Process Development, Quality control/Analytical Development (QC/AD), Environmental Health and Safety (EHS) and Oligo Operations (OPS) to ensure successful technical transfer of scale up and cGMP projects in manufacturing.  
• Responsible for the preparation of technical transfer documentation, raw material forecasting, planning, review, process transfer related deviations and campaign summary reports. 
• Provide oversight over all general Validation activities that cover cross-departmental functions (with support from ENG departments at both sites) 
• Actively communicate appropriate information to representatives of SC, QC/AD, Business Development/Project Management, OPS, Quality Assurance, EHS and Facilities to enable efficient execution of work activities.
• Report status of assigned activities to project teams and to Process Development leadership on a weekly basis or as needed.
• Lead on-boarding activities for new hire employees as well as process training for organizational representatives and possibly clients.
• Maintain an appropriate level of training on company and departmental procedures as determined by Avecia Process Technology.
• Adhere to all company environmental, health and safety policies. 

Job Knowledge Required:  

• BS in Chemistry, Engineering or similar study and 3-5 years of experience in synthetic organic chemistry within a chemical development or manufacturing environment. 
• Broad knowledge of organic chemistry procedures, concepts and literature. 
• Experience in CMO environment with emphasis on technology transfer or CMC is strongly encouraged. Oligonucleotide experience is preferred. 
• Strong understanding of GMP requirements.  
• Demonstrated proficiency in preparation of technical presentations, reports and publications.
• Proficient with Microsoft Office especially Excel. 
• Experience with SAP is recommended. 

The annualized salary range for this position is $83,500.00 - $102,200.00.