Senior Manager External Supply Technical Lead

Main Responsibilities

• Actively participate as API technical lead, and represent Global Technology & Engineering across API Virtual Supply Operations Teams (VSOTs), with other global Pfizer functions ES Ops, RegCMC, COQA, GEHS, DP sites, DP SMEs etc., and Contract Manufacturing Organisations (CMOs).
• 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 status communication
• Lead quality issues investigation at CMOs for complex chemistry, processing or analytical problems related to product quality, or where significant supply challenges, compliance or financial challenges might occur.
• Where appropriate, lead investigational activities at CMOs and across multiple Pfizer functions to execute agreed action plans against timelines and milestones.
• Provide CMOs with the relevant technical input in a timely manner. Review CMO documentation as required, including operating Instructions, analytical data, manufacturing data, specifications and associated technical reports, to identify any technical issues or challenges
• Manage Cost Improvement Projects (CIP’s) directed at reducing costs of API’s at third parties. Provide SME input to the ES API network to improve overall product performance in quality (Ppk) and cost and engage Contract Manufacturing Organisations to ensure the successful delivery of projects, investigations and technical issue resolution within API Manufacturing.
• Provide technical review and approval on QTS for the internal change management process. Responsible for API specifications, process validation and AMTE activities
• Evaluate RSM strategies within the API portfolio and evaluating specification robustness
• Develop plans to improve robustness of processes on a prioritised basis
• Complete Project and Process Risk Assessments, and develop Risk Mitigation options
• Perform FMEAs and API/DP Risk Assessments and work closely with the Material Characterisation Group (MCT) and DP SMEs to ensure API/DP physical property requirements are met for all API transfers and API process changes
• Communicate to key stakeholders in a timely manner on source changes, technical transfers or Cost Improvement Projects wrt project plans / timelines resource / time constraints, scheduling conflicts,
• Evaluate the impact of the source change from a chemistry perspective identifying and leading the implementation of technical solutions to identified issues.
• Ensure GTI and Nitrosamine Assessments have been completed on Pfizer and Supplier processes on a prioritised basis as per PM 28 and ICH M7 guidelines
• Engage other key support functions (e.g. API Process Development Centre, SLS, PASG) to provide additional laboratory and SME support if/as required to deliver to target metrics
• As required and in conjunction with ES API, evaluate and provide technical feedback on supplier relationships and performance

 

 

Education, Background and 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.
• Broad knowledge of technology transfer process and manufacturing for Active Pharmaceutical Ingredients; Good technical understanding of pharmaceutical processes and the impact of technical change
• Demonstrated experience and competence in organising, planning, and problem solving related to qualifying new API suppliers;
• Demonstrated ability to build constructive working relationships with a multi-functional team in support of projects, as well as build positive relationships with the CMOs
• Ability to prioritising activities
• Knowledge of documentation requirements for filing processes; Quality systems, Production
• SME in the area of API development, process or source change qualification and API manufacturing. Broad knowledge of technology transfer process and manufacturing for Active Pharmaceutical Ingredients; 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.
• Excellent Communicationand presentation skills;demonstrated skills at communicating timely and effectively to group/team/customers/peers and supervisor; attention to detail
• Familiarity with the pharmaceutical regulatory environment, and working knowledge of the regulatory change process and filing documentation requirements
• Demonstrated use of Operational Excellence Tools, DMAIC

 

 

Desired Experience:

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

 

Specific Job Requirements

• Some International Travel will be required, approximately 10-20%

 
Work Location Assignment: Hybrid

Engineering