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Experiences

Current Experience

  • Regulatory Affairs Manager CMC and Vendor Manager


    Since October 2013

    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 manager:
    - vendor assessments and evaluations.
    - vendor related Risk Management.

     

     

     

    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 Manager:
    - Vendor assessments and evaluations.
    - Vendor related risk management.

     

     

     

Past Experience

  • Pharmaceutical Chemical Expert

    November 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)

  • Entrepreneur

    January 2006 --- December 2012

    www.lankalinja.fi
    web shop setup and maintenance, Marketing.

  • Project Manager

    October 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 Chemist

    November 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 Scientist

    August 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 Finland

    January 2005 --- August 2006
    lc-msms, Proteomics

  • R&D Scientist

    January 2004 --- December 2004
    same job description as august 2006 – october 2009.

  • Research Scientist / PhD student

    January 1997 --- January 2004

    chromatographic techniques, Cell Culture, membrane and lipid Research, Enzyme studies

    Publications:
    - 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.

Personality

Self Assessment :
AdaptabilityAnalytical thinkingApproachabilityAttention to detailCollaborationCommunicativeCoordinationCritical thinkingCreative thinkingEfficiencyFlexibilityIndependenceInterest in knowledgeOptimismProblem solvingResponsibilityService oriented

Knowledge

LinkedIn Assessment :
ResearchCell CultureGMPCMC Regulatory AffairsAnalytical Method Validationmanufacuring process validationsCTDquality documentationPharmaceutical ResearchPharmaceutical ManufacturingLC-MSMSRegulatory affairsCMCClinical DevelopmentFDA

Education

  • 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

Languages

BrightOwl Assessment:
Self Assessment:
Swedish
Native
Finnish
Full Proficiency
English
Full Proficiency

Area / Region

Finland

Others

Driving License
  • Yes

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