This Pfizer Global Technology & Engineering ES Technical Lead contract role is a global role, reporting within Global Technology and Engineering (GT&E) in Pfizer Innovative Medicines and supporting Global External Supply (GES). 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 source changes a d technical transfers from internal sites to ES API external supply and any associated SME input and leading complex investigations impacting Quality, Supply and Cost. Responsibility for delivering on key targets and milestones in the execution of all projects, whilst ensuring continuity of supply, and providing effective communication to stakeholders on progress
Principle Role Duties:
- Successful transfer of APIs from internal sites to CMOs, generating comparable physical and chemical quality for DP customers, qualifying all identified 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 Global Tech Transfer Teams and associated sub teams as required, including API sites, CMOs, DP sites, DP SMEs, CMC, ESQ, EHS, ES, others, providing the pharmaceutical knowledge and technical support to all Technical Transfer Activity
- 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
- Investigate problems that occur during transfer, scale up of the Pfizer Process and recommend solutions.
- Detailed technical analysis of transferring API Processes, Quality documents etc comparing CMO proposals; writing and reviewing all process related documents, including Technical Reports.
- Lead quality issues investigation at CMO sites where thye may arise in the areas of chemistry, processing or analytical related to product quality, or where significant supply challenges, 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 of GTE DP SMEs and MCT to ensure API physical property requirements are met for all API transfers
- Be a reliable GTE point of contact for team members and other colleagues therefore contributing to the clear and precise communication within the Project Team
- Coordinate the collation of required technical data and review CMO documentation, Operating Instructions, analytical data, manufacturing data, specifications; associated technical reports
- Responsible for process validation activities and project management requirements; review finished goods specifications.
- Work with multifunctional team in solving Technical Transfer related problems (when needed).
- 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 with Dalian and Contract Manufacturing Organisations to ensure the successful delivery of projects, investigations and technical issue resolution within API Manufacturing
- Acts Decisively
- Seizes Accountability
- Grows Self
- Change Agile
- Self Awareness
- Commits to “One Pfizer”
- Builds Peer relationships
Specific Job Requirements
- Some International Travel will be required, approximately 10-20 %
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 organizing, planning, and problem solving related to qualifying new API suppliers;
- Demonstrated ability to build constructive working relationships with a multifunctional 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 Communication and 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
- 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.