Change management, Campaign Lifecycle Management, Tech Transfer

Preparation and revision of production records and instructions in close cooperation with other parts of the organization for new or existing products in the manufacturing facilitet.Preparation of impact assessments on events, change requests and update of working instruction and procedures during manufacturing.Product Lead for MFG Doc team which includes preparing project plan and assigning responsibles for updating campaign related dokuments prior to campaign start, assessing campaign related changes and participating in cross departmental meetings to coordinate campaign readiness.Additional ensuring that all necessary documentation, including update of procedures and preparation of new procedures and batch records was performed for manufacture of new clinical products in cooperation with colleagues in own team and other parts of the organization.

Supervisor for Manufacturing Compliance, Cell Culture and Media Prep Support team.Handling managerial tasks for the team such as planning and coordination of tasks and ressources, sparring with and coaching of employees.Participation in the daily tasks for the team, including creation/revision of Master Production Records, handling of deviation and change requests and revision of working instructions and procedures.

Preparation of production records and instructions in close cooperation with other parts of the organization for start up of new facility for manufacturing of commercial product.Preparation of deviations, change requests and update of working instruction and procedures during manufacturing.Additional ensuring that all necessary documentation, including update of procedures and preparation of new procedures and batch records was performed for manufacture of new clinical products in cooperation with colleagues in own team and other parts of the organization.

Team Leader for technicians and scientists in Downstream Manufacturing, both on day shift and evening shift. Coaching, ressource planning, participating and controlling projects regarding updating working instructions, among other things.

Production responsible for Downstream Manufacturing. Work included planing, performing and closing campaign manufactures of product intended for clinical use. Planning consisted of resource allocation, requesting raw materials, preparing work instructions, buffer sheets and additional documentation used during manufacturing. During manufacturing it was ensured that proper GMP was performed, results were within limits and actions were taken whenever needed. Both planing and performing manufacturing was performed in close cooperation with technicials and scientists in manufacturing, QA, QC and other parts of the company. Closing was performed in cooperation with QA to ensure that all documentation was complete and according to GMP.Preparation of GMP documentation, including deviations, change requests, working instruction and procedures.

Scientist at Diabetes API Process Support, StabilityPreparing and reporting stability studies on Insulin Detemir and Insulin Human Drug Substance

GMP Scientist in Insulin Purification. Implementing and updating GMP rules, training of operators, ensuring that proper GMP was applied during manufacturing.Participating in internal and external audits and inspections and following up and closing any issues following these.Responsible for water quality used during manufacturing, including preparing sample plans and reports used for product release.Preparation of GMP documentation, including deviations, change requests, working instruction and procedures.