Associate Director, External Manufacturing API

Associate Director, External Manufacturing API

Our client, an ambitious global biopharmaceutical based in Dublin, with a strong drug development pipeline and commercial portfolio, now have a permanent role for an Associate Director of API for External Manufacturing within theirvirtual organisation.

This role is based in Ireland, hence this hire will reside in Ireland and hybrid office presence 1 day per week, or every second week plus travel internationally.

The API process expert will be responsible as the technical lead representative supporting API manufacturing at Contract Manufacturing Organizations’ (CMO’s) and subsequent processing of API’s in Drug Product (DP) processes across OSD and injectables.

This hire will support new product introductions, technology transfers, continually monitor and improve API operations conducted at CMO’s for this Biopharma company.

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• Review and maintain company practices & systems in managing contract manufacturers to ensure compliance with cGMP, and other regulatory requirements..
  
• Deep understanding of chemical processes from both scientific and engineering perspective demonstrating expertise in how API processes are developed and controlled to maximize yield and minimize impurities.
  
• Perform trending on CMO API processes and identify opportunities for CI providing technical leadership to implement such improvements to deliver on safety, efficiency and/or compliance.
  
• Oversee activities related to API production across the commercial supply network including routine production and associated monitoring/control plans as well as investigations, change controls and CAPA’s ensuring processes are robust, efficient and in control.
  
• Understand and identify key chemical and physical attributes of API material as it pertains to downstream processing in the drug product process.
  
• For new processes ensure that the process is well defined with appropriate identification of CQAs and CPP’s with appropriate measurement of both.
  
• In conjunction with Commercial Supply Chain oversee network optimization to include vendor selection and technology transfers/validations as required.
  
• Maintain the process control strategy documentation through the commercial part of the lifecycle of the API.
  
• Provide technical input into the commercial master batch records.
  
• Provide input into the Specification and Commercial Purchasing Specification.
  
• Provide technical input into Process FMEA and Change Risk assessments.
  
• Provide technical review of regulatory filings supporting CMC aspects of regulatory dossiers, providing input and guidance around the manufacturing control strategy prior to filing and process validation.
  
• Support validation planning and execution of APIs as needed as part of cross functional teams involving Supply Chain, Quality and Validation.
  
• Work closely with the Process Development providing that link between Development and Commercial manufacturing throughout the product lifecycle. Provide commercial technical requirements for all molecules transitioning from Development to Commercial. Required to provide input and guidance to the manufacturing decision making processes prior to filing and validation.
  
• Support company CMOs in regulatory and external auditor inspections and respond to observations as needed.
  
• Support the Operations leadership with the project management and implementation of key technical projects which are identified as part of the company’s objectives in both CMOs and company facilities.
  
• Manage, coach and develop direct reports ensuring that they deliver and reach their potential.
  

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• Establish and maintain strong working relationships to build partnerships based on trust with CMOs.
  
• Develop recommendations for strategic/business decisions. Provide management with accurate and timely information necessary to make strategic, investment and operating decisions.
  
• Preparation of CMO competency assessment to ensure robust decision-making processes when it comes to vendor selection and vendor optimization discussions with senior management.
  
• Facilitate the transfer of new products and development projects to site’s through the development of effective business cases and management support.
  
• Preparation of credible and reliable business plans, budgets, and forecasts.
  
• Foster and promote internal collaboration.
  
• Ensure support and integration of Technical Operations with relevant functions to achieve customer service objectives.
  

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• Bachelor’s degree in relevant technical/engineering/scientific discipline, preferably multi-disciplinary with a strong technical/scientific (Chemistry / Chemical Engineering) orientation.
  
• 8-12 years’ experience in high volume/manufacturing/relevant environment likely to include:
  
• Pharmaceutical with a minimum of 2 years at senior level.
  
• Established track record with evidence of excellent project management, problem solving, collaborative, leadership and communication skills.
  
• Process safety in API environment.
  
• Strong understanding and experience of technical/scientific challenges in production processes across both API and Drug Product (DP) processes with proven track record demonstrating issue resolution.
  
• Circa 20% of domestic / international travel associated with this role. xcfaprz
  

For further details please contact Larry on /

The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. J-18808-Ljbffr