Mette Pinstrup Jensen Email & Phone Number

Copenhagen, Capital Region, Denmark

Head of department, Analytical Development

Copenhagen Area, Capital Region, Denmark

Head of departement, Analytics and Formulation

Copenhagen Area, Denmark

Team Manager of the Analytical Development team within Analytics & Formulation department

Måløv, Capital Region, Denmark

Associate Manager for development team (Roller Compaction) within Oral Protein Manufacturing Development department

Lejrvej 37-39, 3500 Værløse

Responsibilities and accomplishments:- Managing and leading the Analytical Development department consisting of 3 Analytical Chemists, 4 Laboratory Technicians and one Laboratory assistant- Maintaining and improving the GMP status of the laboratory- Developing the employees, conducting performance appraisal interviews and supporting in identifying personal goals- Facilitating the work in the department incl development of analytical methods, release testing of IMP, stability… Show more Responsibilities and accomplishments:- Managing and leading the Analytical Development department consisting of 3 Analytical Chemists, 4 Laboratory Technicians and one Laboratory assistant- Maintaining and improving the GMP status of the laboratory- Developing the employees, conducting performance appraisal interviews and supporting in identifying personal goals- Facilitating the work in the department incl development of analytical methods, release testing of IMP, stability studies, qualification of equipment, etc- Hiring of an Analytical Chemist and a Laboratory Assistance Show less

Responsibilities:- Managing and leading all CMC development activities incl. management of US based CMO as well as toxicology study conduct and Clinical Trial Supply- Participating in global development teams as CMC/R&D representative- Collecting project budget inputs and preparing and controlling Purchase Orders to cover costs for activities at CMO, CRO and consultantsAccomplishments:- Managing and leading three CMC development projects incl. management of production… Show more Responsibilities:- Managing and leading all CMC development activities incl. management of US based CMO as well as toxicology study conduct and Clinical Trial Supply- Participating in global development teams as CMC/R&D representative- Collecting project budget inputs and preparing and controlling Purchase Orders to cover costs for activities at CMO, CRO and consultantsAccomplishments:- Managing and leading three CMC development projects incl. management of production and analytical testing activities at the CMO- Coordinating the conduct of three toxicology studies (rat study and two genotox studies) of an impurity through consultants and CRO’s- Coordinating the supply of study medication for three Bioequivalence studies, two phase 3 studies and several Human Abuse Potential studies- Coordinating the preparation of module 3 documents for several INDs (phase 1 and phase 3) and an NDA. In addition coordinating the work related to generation of responses to FDA requests during Pre-approval Inspection and NDA review process. Show less

Cmc Project Management

Responsibilities:- Leading, motivating and managing Global CMC teams to achieve deliverables and to meet defined project scope for early stage (FIM, ph I and ph II) as well as late stage (Life Cycle Management) development projects - Being member of cross-divisional governance teams (e.g. Global Project teams) as CMC representative - Ensure that the project is delivered with quality, on time, within budget and with acceptable risk profile - Collect inputs and prepare budgets and… Show more Responsibilities:- Leading, motivating and managing Global CMC teams to achieve deliverables and to meet defined project scope for early stage (FIM, ph I and ph II) as well as late stage (Life Cycle Management) development projects - Being member of cross-divisional governance teams (e.g. Global Project teams) as CMC representative - Ensure that the project is delivered with quality, on time, within budget and with acceptable risk profile - Collect inputs and prepare budgets and estimates on project related CMC costs incl resource estimates- Managing outsourcing activities incl. vendor selection and partner relationship management - Managing interfaces to internal production sites - Communication and information to key stakeholdersAccomplishments:- Preparation of IND for phase II and supply of study medication for phase II through a US partner- Coordination of all CMC development activities on a full in-house project (manufacture of API, manufacture of IMP, preparation of IMPD etc.) leading to the application for a First In Man study- Managing and leading several teams involved in Life Cycle Management activities for a marketed Calcium/VitaminD3 product portfolio. Having 2 new products on the market and 5 additional products ready for MAA submission. In parallel to this changing the formulation of the main portfolio to a new optimised formulation.- Establishment of two different dermal formulations at a CMO and production of clinical material for two clinical studies (Ph I and Ph II) including the preparation of IMPDs for both products. Show less

Analytical Development Lab.

Responsibilities:- Responsible for all practical work incl documentation for allocated projects incl.: (a) Project management of specified projects incl. responsibility for meeting the milestones agreed with the Steering Committee as well as reporting project progress (b) Development and validation of analytical methods incl. specifications for substances/product, planning and conducting stability studies, preparation of analytical-chemical parts of the registration documentations… Show more Responsibilities:- Responsible for all practical work incl documentation for allocated projects incl.: (a) Project management of specified projects incl. responsibility for meeting the milestones agreed with the Steering Committee as well as reporting project progress (b) Development and validation of analytical methods incl. specifications for substances/product, planning and conducting stability studies, preparation of analytical-chemical parts of the registration documentations and Drug Master Files (c) Maintenance of existing registration documentation (d) Transfer of analytical methods to routine manufactures and contract laboratories- Responsible for the laboratory’s chromatography data systemAccomplishments:- Involved (responsible for the analytical-chemical part and responsible for project coordination) in the development of 5 Drug Products (tablets and creams) which were all submitted and approved by the authorities mainly in Europe, but also outside EU. - For two products I was responsible for the development of the Drug Substance and prepared the Analytical part of the Drug Master Files. Show less

Responsibilities:- Optimisation of a dissolution method as well as the development and validation of a new HPLC method for determination of assay and related substances of an extended release tablet product.

Master Of Science (Ms), Pharmacy

Education record