Job Description

Responsibilities

• Act as the primary Technical Lead on the Virtual Site Operating Team (VSOT), coordinating technical activities with CMOs and aligning deliverables across internal and external stakeholders
• Actively participate in and lead Global Tech Transfer Teams and associated sub teams as required, including internal API sites, CMOs, DP sites, DP SMEs, CMC, ESQ, GEHS, ES, others global functions 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
• Detailed technical analysis of transferring API Processes, Quality documents etc. comparing to CMO proposals; writing and reviewing all process related documents, including Technical Reports
• Perform Risk assessment on all source changes including Project and process RAs, API/DP RAs, GTI / NNO RAs
• Investigate problems that occur during transfer, scale-up of the Process and recommend solutions.
• Lead quality issues investigation at CMO sites for complex chemistry, processing or analytical problems related to product quality, or where significant supply challenges, compliance or financial challenges might occur.
• Chair sub-team activities scheduling Project meetings, preparing agendas and generating minutes, preparation of reports, presentations and correspondences
• Engage the support of GTEL DP SMEs and MCT to ensure API physical property requirements are met for all API transfers
• Be a reliable GTEL point of contact for project team members and other colleagues to escalate issues and engage the T4 functional leads as needed
• Proactively identify, communicate, and implement required project/plan issues and support the implementation of the corresponding resolution, coordinating the related action plan activity
• 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; reviewing 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 reduction (PPRP). Supports issue resolution with CMOs in Manufacturing, Risk Mitigation, analytical problems related to product quality, AMTE data.
• Achieving and reporting on iTT metrics for all related projects being worked upon Coordinate the collation of required technical data and review CMO documentation, Operating Instructions, analytical data, manufacturing data, specifications; associated technical reports
• Support the implementation of agreed strategies and validation activities associated with the different API Technical Transfers.

Qualifications

Education:

• The candidate should have BSc in Biochemistry, Chemistry or related fields. A MSc or PhD is desirable.

Required Experience:

• 5+ years in pharmaceutical manufacturing senior/leadership technical roles.
• Recognized expertise in peptide drug substance manufacturing, with advanced knowledge of SPPS, resin chemistry, and purification strategies to support GMP operations, validation, and regulatory submissions.
• Broad knowledge of technology transfer process and manufacturing for Active Pharmaceutical Ingredients; Good technical understanding of pharmaceutical processes and the impact of technical change.
• Strong understanding of biomolecular chemistry and stability characteristics.
• Good understanding of Drug Product manufacturing in highly regulated environment
• 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 prioritize activities
• Knowledge of documentation requirements for filing processes; Quality systems, Production
• SME in the area of peptide chemistry, purification, GMP standards, 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 changes (ICH Q9)
• 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 filingdocumentation requirements.
• Demonstrated understanding of GMP manufacturing expectations and international regulatory requirements in accordance with ICH and major health authorities (FDA, EMA, PMDA, etc.).
• Demonstrated use of Operational Excellence Tools, DMAIC

Specific Job Requirements

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Ability to work outside of core business hours when projects demand global collaboration

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
• Strong knowledge of Analytical Techniques and methods.
• Demonstrated ability to resolve conflicts.
• Knowledge / Experience of Drug Product processes/ Process Safety and general EHS requirements

OTHER INFORMATION

• Work Location Assignment: Hybrid
• Relocation not available
• Colleague must be based in the US, preference given to Pacific Time Zone.
• Qualified applicants must be legally authorized to work in the United States on a full‑time basis for any employer. Company does not sponsor employment‑based visas for this position

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