Stephan B.
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Stephan B. Email & Phone Number

Analytical Study Coordinator at Abylsen
Location: Contact Info, United States 6 work roles 3 schools
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Current company
Abylsen
Role
Analytical Study Coordinator
Location
Contact Info, United States
Company size
799 employees

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Stephan B. is listed as Analytical Study Coordinator at Abylsen, a with 799 employees, based in Contact Info, United States. AeroLeads shows a matched LinkedIn profile for Stephan B..

Stephan B. previously worked as Analytical Senior Scientist CMC at Galderma and Chef de projet Developpement analytique at Sps Pharma Services. Stephan B. holds Licence, Industrie Chimique Et Pharmaceutique - Analyse Et Contrôle from Université Nice Sophia Antipolis.

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Abylsen

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About Stephan B.

I contribute to design and oversee scientific studies including active pharmaceutical ingredient and drug product to support technical programs from early development into confirmatory development / clinical studies and technology transfer up to the registration. I support as needed manufacturing processes at the commercial site (i.e., maintenance) and I provide analytical support to trouble-shooting activities associated with established products in situations of OOT and OOS with preparation of position papers.My major activities include key activities such as product characterization, analytical development strategy including method development / optimization / validation / transfer and proposal for specifications and analytical control strategies. I also ensure follow-up stability programs and proposal for packaging safety strategy (including recommendations and assessment for leachable and extractables).I manage fully externalized projects including activities linked to analytical development with following and assuring activities in collaboration with CRO / CMO.My main achievements are on small molecules in the scope of contraception, postmenopausal diseases, endometriosis and skin disease (keratosis actinic, rosacea and Jak inhibitor) through development of oral dosage forms (2 on Market, 1 phase II), 6 semi-solid dosage forms (3 on Market, 2 phase II) and 2 API in « early development » stage.I am more than 20 years’ experience in Pharmaceutical Development (solid and semi solid dosage forms, small molecules) and problem-solving skills in Analytical Chemistry.

Current workplace

Stephan B.'s current company

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Abylsen
Abylsen
Analytical Study Coordinator
lyon, auvergne-rhône-alpes, france
Website
abylsen.com
Employees
799
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6 roles

Stephan B. work experience

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Analytical Study Coordinator

Current
Abylsen

Nice, Provence-Alpes-Côte D’Azur, France

For Virbac Laboratories:- Coordination of analytical transfers to external partners and within the Organization.- Supervision of R&D analytical development and stability programs.

Mar 2023 - Present

Analytical Senior Scientist Cmc

Galderma

Région De Lausanne, Suisse

Analytical Senior Scientist for small molecule drug substance and drug product development activities for Global R&D.Lead analytical development strategy (method development / optimization / validation / transfer), and specifications proposals with analytical control strategies.Lead and support to Operations trouble-shooting activities in analytics and with commercial products in situations of OOT and OOS.Lead E&L (extractable and leachables) strategy for pack changes.Management of fully externalized projects in terms of analytics, stability studies.

Dec 2018 - Feb 2023

Chef De Projet Developpement Analytique

Sps Pharma Services

Orléans, Centre-Val De Loire, France

Ensure development and validation of analytical dissolution methods (USP I, USP II and USP IV) according to Eur. and US regulations (Ph. Eur., EMEA, USP, FDA, ICH) and according to customer requirements.

Mar 2018 - Dec 2018

Chargé De Recherche Développement Analytique

Theramex

Monaco

Coordination of analytical studies with transverse activities (QC, Manufacturing site, formulation team) and with CDMO and CRO).Development, validation / analytical transfer (UPLC, HPCL, CPG, Dissolution, laboratory software),Finished product in pharmaceutical development environment (scale-up, process validation).Support drug product packaging selection in terms of quality, compatibility and extractables / leachables.ICH stability studies and stability data assessment to support development, specifications settings and product shelf-life.Support manufacturing and laboratory investigations in case of OOT / OOS.QBD approach with definition of QTPP, ATP et CQA.Contribute to laboratory organization (schedule, documentation, qualification, maintenance, investments).Management of 2 technicians with technical support, training and performance assessment.Involved in IND, IMPD, CTD and module III of the AMM.

Mar 2009 - Jan 2016

Senior Technician

Theramex

Monaco

Mar 2005 - Mar 2008

Technicien Recherche Et Développement

Theramex

Monaco

Oct 1998 - Mar 2005
Team & coworkers

Colleagues at Abylsen

Other employees you can reach at abylsen.com. View company contacts for 799 employees →

DS Dimitri Sailly Dimitri Sailly Colleague at AbylsenRoubaix, Hauts-De-France, France View → FC Frédéric Chevalier Frédéric Chevalier Colleague at AbylsenLa Biolle, Auvergne-Rhône-Alpes, France View → MP Mattia Parolin Mattia Parolin Colleague at AbylsenTurin, Piedmont, Italy View → PC Paul Cazal Paul Cazal Colleague at AbylsenToulouse, Occitanie, France View → MV Matthias Van De Velde Matthias Van De Velde Colleague at AbylsenAalter, Flemish Region, Belgium View → SB Samuel Bielik Samuel Bielik Colleague at AbylsenLille, Hauts-De-France, France View → GD Gayot Damien Gayot Damien Colleague at AbylsenGreater Lille Metropolitan Area, France View → RB Raphaël Benaglia Raphaël Benaglia Colleague at AbylsenLille, Hauts-De-France, France View → MB Mickael B. Mickael B. Colleague at AbylsenNancy, Grand Est, France View → TR Thomas Rocheteau Thomas Rocheteau Colleague at AbylsenLille, Hauts-De-France, France View →
3 education records

Stephan B. education

FAQ

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What company does Stephan B. work for?

Stephan B. works for Abylsen.

What is Stephan B.'s role at Abylsen?

Stephan B. is listed as Analytical Study Coordinator at Abylsen.

Where is Stephan B. based?

Stephan B. is based in Contact Info, United States while working with Abylsen.

What companies has Stephan B. worked for?

Stephan B. has worked for Abylsen, Galderma, Sps Pharma Services, and Theramex.

Who are Stephan B.'s colleagues at Abylsen?

Stephan B.'s colleagues at Abylsen include Dimitri Sailly, Frédéric Chevalier, Mattia Parolin, Paul Cazal, and Matthias Van De Velde.

How can I contact Stephan B.?

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What schools did Stephan B. attend?

Stephan B. holds Licence, Industrie Chimique Et Pharmaceutique - Analyse Et Contrôle from Université Nice Sophia Antipolis.

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