Senior Technical Manager (MS&T), ESO

About the job

Job Description Summary As a product technology expert, responsible within the External Supplier Relation-ship team for the management of products throughout their lifecycle, oversight of processes by data trending and statistical analysis of critical parameters, and for ensuring product robustness, proper validation status, and continuous process improvement. Job Description Key Responsibilities: • Maintains oversight of processes for the assigned product in a specific contract manufacturing organization (e.g. from raw materials to packaging). • Maintains the knowledge and the history of the products throughout the commercial lifecycle, since transfer from development to the present moment. • Liaises with the global/X-CMO product steward at the global level, acting as a representative of MS&T within the relevant supplier relationship teams. Closely cooperates with ESO functions (Quality Assurance, Site Change Coordinator, SCM, etc.), and establishes relations with CMOs with special focus to ensure and improve product process capability, to keep up to date the knowledge of the process and to maintain the product in a constant state of validation. • Controls and ensures the maintenance of technical documentation, e.g. process transfer protocols/reports, comparability protocol/reports. • Authoring/reviewing relative source documents for dossier, HA query and other RA tasks. • Participate in deviation investigation, lead complex investigations. • Ensure that product and process-related issues identified in the OPV / APQR process with CAPA assigned are remediated with clear interfaces with Quality, AS&T, Operations, Engineering and Technical Development (as needed). • Science and risk-based approaches, to ensure that product quality can be sustainably reproduced once transferred into the CMO site. • Decision to transfer to CMO based on technical evaluation at transferring and receiving organization and aligned with strategy. • Actively participates in and represents their products in the relevant committee (e.g. Product Stewardship Committee) when improvements of non-conformable products are planned, priorities are set, and improvements are monitored. • Ensures that technical batches provide sufficient process knowledge by thoroughly testing critical variables; uses the data obtained to verify critical process parameters. • Provides all the information needed for validation documentation. • Supports the validation lead and experts in assessing the need and planning validations / re-validations / verifications / annual batch monitoring, consulting, approving and reviewing the process validation master plan in cooperation with the above.

Requirements

• Product technology expertise
• Statistical analysis
• Process management
• Communication skills
• Team player

Qualifications

• Bachelor’s degree in science or pharma or equivalent
• Minimum 15+ years of experience in biotechnology industry preferably in large molecule

Preferred Technologies

• Product technology expertise
• Statistical analysis
• Process management
• Communication skills
• Team player