Job Purpose: 

This Pfizer Global Technology, Engineering and Launch ES Technical Lead role is a global role, reporting within Global Technology, Engineering and Launch (GTEL) in Pfizer and supporting External Supply (ES). A key function of the role is the successful Technology Transfer of APIs to Contract Manufacturing Organisations in Europe and Asia. The role specifically entails providing prompt technical subject matter expertise and technical leadership to associated virtual Supply Operating Teams (VSOT)s , leading ES API source change projects and complex investigations impacting Quality, Supply and Cost, with responsibility for delivering on key targets and milestones in the execution of VSOT projects, whilst ensuring continuity of supply, and providing effective communication to stakeholders on progress.  

Principle Job Duties: 

• Successful transfer of APIs to CMOs (Contract Manufacturing Organisations), generating comparable physical and chemical quality for DP, qualifying all relevant markets, and meeting the business milestones and drivers. Coordinate execution of agreed action plans to meet timelines and milestones. 

• Proactively identify, communicate, and implement required project/plan issues and support the implementation of the corresponding resolution, coordinating the related action plan activity. 

• Actively participate in and lead Technology Transfer Teams and associated sub teams as required, including API sites, CMOs, DP sites, DP SMEs, CMC, QA, EHS, and External Supply, providing the pharmaceutical knowledge and technical support for all technology transfer activities. 

• Lead ES API Source Change activity and qualification of alternate CMO suppliers, building and leading cross-functional project teams, developing and maintaining project and program implementation plans, chairing meetings, scheduling of activity, responsibility for action tracking, reports, meeting minutes, presentations and communications. 

• Investigate problems that occur during transfer, and scale up of API processes, and recommend solutions. 

• Present technical findings and recommendations to senior leadership and external stakeholders 

• Detailed technical analysis of transferring API processes, quality documents, etc. comparing CMO proposals; writing and reviewing all process related documents, including technical reports. 

• Lead complex quality investigations at CMOs typically involving chemistry, processing or analytical problems related to product quality, or where significant supply, compliance or financial challenges might occur. 

• Chair sub-team activities scheduling project meetings, prepare agendas and generate minutes; preparation of reports, presentations and correspondences. 

• Engage the support DP SMEs and MCT (Material Characterisation Team) to ensure API physical property requirements are met for all API transfers and source changes. 

• Author and review technical reports, protocols, and regulatory submissions related to API manufacturing processes and product quality. 

• Be a reliable technical point of contact for team members and other colleagues, thereby contributing to the clear and precise communication within the project team 

• Serve as the primary technical leader for API manufacturing processes, including synthesis and purification, resolving complex technical challenges and driving continuous improvement initiatives. 

• Coordinate the collation of required technical data and review CMO documentation, operating instructions or batch records, analytical data, manufacturing data, specifications, and associated technical reports 

• Responsible for process validation activities and project management requirements, and review finished goods specifications. 

• Work with multifunctional team in solving technology transfer related problems, as required. 

• Manage Cost Improvement Projects (CIPs) directed at reducing costs of APIs at third parties. Provide SME input to the ES API network to improve overall product performance (e.g. Ppk and yield) and engage with CMOs to ensure the successful delivery of projects, investigations and technical issue resolution within API manufacturing. 

• Support issue resolution with CMOs in manufacturing, risk mitigation, analytical problems related to product quality, analytical method transfer or validation data. 

Education, Background and / or Experience: 

• Bachelor’s degree in chemistry, chemical engineering or related scientific discipline.  Advanced degree preferred, with broad post-Bachelor's experience relevant to the pharmaceutical industry. 

• Deep technical knowledge of API / Drug Substance manufacturing equipment and unit operations. 

• Demonstrated experience and competence in organising, planning, and problem solving related to qualifying new API suppliers. developing and implementing innovative approaches to solving problems.  

• Demonstrated ability to build constructive working relationships with a multifunctional team in support of projects, as well as building positive relationships with the CMOs 

• Oversee the design, execution, and interpretation of experiments to optimise existing API manufacturing processes, enhancing yield, reducing cost, and/or improving product quality.  

• Knowledge of documentation requirements for filing processes; quality systems, and production.  

• SME in API development, process or source change qualification and API manufacturing. Broad knowledge of technology transfer process and manufacturing for APIs; good technical understanding of pharmaceutical processes and the impact of technical change  

• Demonstrated ability to work on multiple projects with multiple sites and functions.  

• Ability to work independently and provide innovative solutions to challenging problems. 

• Demonstrated ability to manage and prioritise competing priorities and to appropriately communicate verbally and in writing to various audiences. 

• Familiarity with the pharmaceutical regulatory environment, and working knowledge of the regulatory change process and filing documentation requirements  

• Demonstrated use of Operational Excellence (OpEx) tools, and DMAIC approach to investigations. 

Desired Experience:  

• Understanding of project and team relationship principles in cross functional and/or culturally diverse work environment. 

• Minimum five years of work experience in contract manufacturing related role related to small molecules. 

• Minimum five years of direct experience leading commercial API technology transfers and alternative source qualifications at external CMOs for products registered in multiple global markets 

 

• Demonstrated ability to function in a team environment as a technical leader and as a member of teams. 

• Knowledgeable in production Quality, GMP, and validation processes, procedures, and policies. 

• Proficiency with project management software, Excel and PGS databases 

• Knowledge of Risk Management principles 

• Demonstrated ability to resolve conflicts.  

• Knowledge / Experience of Drug Product process/ Process Safety and general EHS requirements 

• Ability to work effectively in a fast-paced, dynamic, and highly collaborative environment. 

Work Location Assignment: Hybrid

This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.

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Engineering