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 im-provement.
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.
Essential Requirement:
Minimum 15+ years of experience in biotechnology industry preferably in large molecule, C > domain.
Strong experience in process/product expertise.
Good understanding of regulated systems, concurrent validations and guidelines.
Technically astute and can communicate business needs to stakeholders
Skills:
Demonstrated skills in trouble shooting of systems, with working knowledge of incident and problem management processes Data Analytics
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.
Ability to manage change effectively always mindful of business processes, and system implications Quick learner with the ability to develop an in-depth knowledge of healthcare provider regulation requirements
Desirable Requirement:
Education: Bachelor’s degree in science or pharma or equivalent
Languages: English
Skills Desired