Senior Technical Manager Drug Substance

#LI – Hybrid

Location: Poland

Major accountabilities:

• Maintains oversight of processes for the assigned product in a specific contract manufacturing organization (e.g. from raw materials to packaging) and 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. Monitoring routine manufacturing performance following transfer to CMO
• Participation in the CRB and in escalation meeting to represent the technical evaluations of the proposed changes and deviations. Tracking the parameters for continuous process verification received from CMOs. Monitors all critical variables and key variables as required for the assigned products (critical process parameters, in-process control parameters, quality attributes, characteristics of raw materials, etc.) by means of statistical analysis and by performing regular data trending for specific products.
• Understanding and management of data trending and statistical analysis for the following purposes: Deepening and broadening process understanding and knowledge. Detecting issues related to process capability, e.g. systematic quality defects. Identifying trends of process deviations (e.g. deviation with a common root cause). Issuing/approving quarterly/annual data trending reports. Ensures data and trend sharing within the Supplier Relationship teams, and coordination of resolutions with CMOs. Through appropriate documentation and support to the product receiving/transferring site, provides the necessary data for the technical activities involved in the product transfer, while focusing on the existing knowledge. Initiates investigations and improvement projects (quality, efficacy) based on data analysis, engaging cross-functional teams.
• 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. Approves validation protocols and reports. Ensures harmonization of (regulatory) timelines for technical changes (e.g. for drug substances), transfers or launches, major deviations. Reviews the PQR data and ensures proper discussion about it. Provides the necessary support in internal and external audits.

Minimum Requirements:

• Bachelor’s degree in science or pharma or equivalent
• Minimum 15+ years of experience in biotechnology industry preferably in large molecule, C&GT domain
• Strong experience in process/product expertise  and good understanding of regulated systems, concurrent validations and guidelines, technically astute and can communicate business needs to stakeholders
• Demonstrated skills in trouble shooting of systems, with working knowledge of incident and problem management processes
• Strong team player in global matrix team organization with an ability to confidently manage both pharma and non-pharma professionals
• Ability to work independently under time and pressure constraints, demonstrated ability to be proactive and flexible
• Strong communication and interpersonal skills and acute attention to detail 
• Excellent English language

Desirable Requirements:

• Quick learner with the ability to develop an in-depth knowledge of healthcare provider regulation requirements
• Ability to manage change effectively always mindful of business processes, and system implications