Regulatory Affairs Manager CMC and Vendor Manager
Since October 2013
cmc Regulatory Affairs, Project Management (Pharmaceuticals and Medical Devices)
- authoring, evaluation and review of ma and ce mark application Documentation with focus on quality aspects.
- customer Quality System setup and audit (devices) global ma maintenance Documentation (e.g. variations, renewals, annual reports).
- Manufacturing process Validation/ Qualification/ Verification Documentation (Pharmaceuticals and Medical Devices).
- risk assessments regulations (FDA, emea, glp, GMP, ich, ISO).
- Business Development and customer relationship management
- knowledge in ICH guidelines.
Regulatory Affairs Manager CMC:
CMC Regulatory Affairs, Project Management (pharmaceuticals and medical devices)
- Authoring, evaluation and review of MA and CE mark application documentation with focus on quality aspects.
- Customer quality system setup and audit (devices) Global MA maintenance documentation (e.g. variations, renewals, annual reports).
- Manufacturing process validation/ qualification/ verification documentation (pharmaceuticals and medical devices).
- Risk assessments Regulations (FDA, EMEA, GLP, GMP, ICH, ISO).
- Business Development and Customer Relationship Management
- Knowledge in ICH guidelines.
- Vendor assessments and evaluations.
- Vendor related risk management.
Pharmaceutical Chemical ExpertNovember 2011 --- October 2013
cmc Regulatory Affairs:
- Project Management of customer projects.
- authoring, evaluation and review of global ma Documentation (ctd; module 2 and 3), global ma maintenance Documentation (e.g. variations, renewals, annual reports).
- Manufacturing process Validation/ Qualification/ Verification Documentation.
- regulations (FDA, emea, GMP, ich) stability study Documentation (ich)
Project ManagerOctober 2010 --- September 2011
- esr Project Management.
- Lecturer in quality Training (iso9000 and iso14000).
- networking and strengthening of the knowledge of small and medium size companies in the uusikaupunki region.
- promoting and developing the business services of the college.
- administration and Budgeting of the project.
Design Transfer ChemistNovember 2009 --- October 2010
transfer of Medical Device (IVD) products from r&d to production. ensuring a smooth startup of Manufacturing processes keeping up contacts and communicating with different functions. process characterizations and validations (FDA,emea, GMP). Analytics; lc-msms specialist instructing Research assistants in the Laboratory. writing plans, reports, batch records, working instructions, product information sheets, kit inserts, labels, msds and other types of documents.
R&D ScientistAugust 2006 --- October 2009
function as a responsible Scientist and Expert of bioanalytics in nonclinical and Clinical projects. keeping up contacts and communicating with different functions both inside and outside of orion pharma. development and Validation of Analytical methods and pre-Treatment methods for samples of Biological origin. (glp) instructing Research assistants in the Laboratory. writing plans, reports, working instructions, regulatory documents and other types of documents. participation in writing of Clinical Documentation and investigators brochure’s. analyzing of drug candidates and metabolites in Biological matrices (incl. nonclinical and Clinical). analyzing of production samples (GMP). lc-msms and uplc-msms specialist. Outsourcing, product maintenance, stability studies (ich) and process control Analytics.
Post Doc / Academy of FinlandJanuary 2005 --- August 2006
R&D ScientistJanuary 2004 --- December 2004
same job description as august 2006 – october 2009.
Research Scientist / PhD studentJanuary 1997 --- January 2004
- p. leppimäki, r. kronqvist and j. p. slotte: the rate of de novo sphingomyelin synthesis is influenced by the level of cholesterol in cultured human skin fibroblasts. (1998) biochem. j. 335(2):285-291.
- r. kronqvist*, p. leppimäki*, and j. p. slotte: the effect of interleukin-i on the synthesis of cholesterol, phosphatidylcholine and sphingomyelin, and their efflux from fibroblasts to lipid-free apolipoprotein a-i. (1999) eur. j. biochem. 262:939-946. [*equal contribution]
- b. ramstedt, p. leppimäki, m. axberg and j.p. slotte: Analysis of natural and synthetic sphingomyelins using high-performance thin-layer Chromatography. (1999) eur. j. biochem. 266:1-7.
- p. leppimäki, j. mattinen and j. p. slotte: sterol-induced upregulation of phosphatidylcholine synthesis in cultured fibroblasts is affected by the double-bond position in the sterol tetracyclic ring structure. (2000) eur. j. biochem. nov;267(21):6385-94.
- k. lundin, p. leppimäki, c. oetken, t. nordström and c. lindqvist: production and partial Characterization of mouse Monoclonal Antibodies recognizing common cytokine receptor gamma chain of human, mouse and primate origin. (2001) apmis 109:647-655.
- h. ohvo-rekilä, b. ramstedt, p. leppimäki and j.p. slotte: cholesterol interactions with phospholipids in membranes. review (2002) progress in lipid Research 41:66-97.
- s. högback, p. leppimäki, b. rudnäs, s. björklund, j.p. slotte and k. törnquist: ceramide 1-phosphate increases intracellular free calcium concentrations in thyroid frtl-5 cells: evidence for an effect mediated by inositol 1,4,5-trisphosphate and intracellular sphingosine 1-phosphate. (2003) biochem j. feb 15;370(pt 1):111-9. p.
- leppimäki: sterolkonformationens betydelse för membranstrukturer. (2001) kemia-kemi 1.
AdaptabilityAnalytical thinkingApproachabilityAttention to detailCollaborationCommunicativeCoordinationCritical thinkingCreative thinkingEfficiencyFlexibilityIndependenceInterest in knowledgeOptimismProblem solvingResponsibilityService oriented
Doctor of Philosophy (PhD) in Biochemistry from Åbo Akademi in 2002
Master of Science (MSc) in Biochemistry from Åbo Akademi in 1996
Matriculation Exam in from Kyrkslätts gymnasium in 1991