Drazen Simic

Drazen Simic Email and Phone Number

Pharmaceutical Specialist Lead @ Organon Benelux
Nijmegen, GE, NL
Drazen Simic's Location
Nijmegen, Gelderland, Netherlands, Netherlands
Drazen Simic's Contact Details

Drazen Simic personal email

About Drazen Simic

• I am an experienced and motivated organic chemist, specialized in the development and scaling up of new synthesis routes for the production of (pre-) clinical batches of new pharmaceutical products. • I gained my extended experience in (multidisciplinary) project teams where I had a great responsibility for my work to ensure that work with quality was delivered on time. • In an environment where people are ready for each other and where people taken responsibilities I really like. • My planning and control skills are excellent and therefore projects are completed before the deadline.Specialties: • Skilled in the development and scale up of new synthetic routes. • Knowledge of cGMP• Independent planning and implementation of chemical synthesis routes to support the production of clinical batches. • Transfer of processes from research into production• Participation in multidisciplinary project teams.• Quality • Chemical and process safety research• Organic ChemistrySince 2013, I am working as Pharmaceutical Specialist at MSD.

Drazen Simic's Current Company Details
Organon Benelux

Organon Benelux

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Pharmaceutical Specialist Lead
Nijmegen, GE, NL
Website:
organon.com
Employees:
7254
Drazen Simic Work Experience Details
  • Organon Benelux
    Pharmaceutical Specialist Lead
    Organon Benelux
    Nijmegen, Ge, Nl
  • Organon Benelux
    Pharmaceutical Specialist Lead
    Organon Benelux May 2021 - Present
    Oss, North Brabant, Netherlands
  • Msd Netherlands
    Compliance Engineer
    Msd Netherlands Apr 2019 - Apr 2021
    Oss, North Brabant, Netherlands
  • Msd Netherlands
    Pharmaceutical Specialist (Solids)
    Msd Netherlands Jul 2013 - Mar 2019
    Nijmegen Area, Netherlands
    - Deviation handling/coordination (incl. complaints, root-cause analysis, evaluation of deviations)- Control that production is executed in line with the guidelines.- CAPA handling/coordination- Change Control coordination- Making sure that deviations, CAPAs, changes and audit observations are handled in a timely and correct manner. Creating trend and periodic reports with respect to these quality systems.
  • Msd Netherlands
    Officer Process Compliance
    Msd Netherlands May 2012 - Jun 2013
    Oss, Netherlands
    Writing Product Quality Review (PQR) ICH Q7 guidelines. The job also includes an active participation in an improvement project within the Quality Unit of API-BT.
  • Recticel
    Chemical Process Technologist
    Recticel Jan 2012 - Apr 2012
    Kesteren
  • Merck Sharp & Dohme (Oss)
    Compliance Officer
    Merck Sharp & Dohme (Oss) Apr 2011 - Oct 2011
    Assessing the content of GMP action steps in response to internal audits and monitoring status. Providing performance reports and make proposals for improving work processes.Collaborating in Lean Manufacturing improvement.
  • Merck Sharp & Dohme (Msd), Oss
    Senior Development Specialist And Assistant Process Safety Research
    Merck Sharp & Dohme (Msd), Oss Oct 2009 - Mar 2011
    Performing process safety studies. Familiar with Mettler Toledo RC-1, DSC, TGA, Mettler Toledo Multimax.The duties of Senior Development Specialist remained unaltered.
  • Merck Sharp & Dohme (Oss)
    Senior Development Specialist\Kilolab
    Merck Sharp & Dohme (Oss) Apr 2006 - Sep 2009
    Independently responsible for projects.Participation in multidisciplinary project teams.Early detection and reporting of problems and deviations.
  • Merck Sharp & Dohme
    Development Specialist\Kilolab
    Merck Sharp & Dohme May 2003 - Mar 2006
    Developing processes and on time delivery of Active Pharmaceutical Ingredients for the first and second phase clinical trials of potential new drugs.Performing organic chemical reactions on a laboratory scale and scale-up in purpose reactors ranging from 5 to 250 L.Performing and interpretation of analysis (HPLC, NMR, TLC, MS). Performing process risk assessments. Writing process safety reports, batch sheets, batch records and transfer documentation. Responsible for correct implementation of GMP and EHS.
  • Merck Sharp & Dohme
    Technical Assistant\Kilolab
    Merck Sharp & Dohme Jun 2001 - Apr 2003
    Supervising and assisting with Periodical Maintenance. Performing qualification of process equipment. Participate in the functional improvements of the process equipment.
  • Diosynth Nv
    Project Assistant At R&D
    Diosynth Nv Jun 2000 - May 2001
    Theoretical and practical implementation of R&D processes in production.
  • Lincoln Electric
    Assistant Team/Group Leader
    Lincoln Electric Sep 1997 - May 2000
    Nijmegen Area, Netherlands
    Operational leadership to process operators.Training and coaching of new employees.Ensuring the production progress and the quality.
  • Siporex
    Lab Assistant
    Siporex Aug 1993 - Aug 1995
    Tuzla (Bosnia&Herzegowina)
    Analysis of raw materials and finished products.

Drazen Simic Skills

Responsible Gmp Quality Process Development Organic Chemistry Process Simulation R&d Chemistry Capa Quality System Validation Corrective And Preventive Action

Drazen Simic Education Details

  • Avans Hogeschool Breda
    Kwaliteit- En Verandermanagement
  • Prince2
    Prince2
    Project Management
  • Chemical Tehnology
    Chemical Tehnology
  • Secondary Technical School
    Secondary Technical School
    Chemical Technology

Frequently Asked Questions about Drazen Simic

What company does Drazen Simic work for?

Drazen Simic works for Organon Benelux

What is Drazen Simic's role at the current company?

Drazen Simic's current role is Pharmaceutical Specialist Lead.

What is Drazen Simic's email address?

Drazen Simic's email address is si****@****ail.com

What schools did Drazen Simic attend?

Drazen Simic attended Avans Hogeschool Breda, Prince2, Chemical Tehnology, Secondary Technical School.

What skills is Drazen Simic known for?

Drazen Simic has skills like Responsible, Gmp, Quality, Process Development, Organic Chemistry, Process Simulation, R&d, Chemistry, Capa, Quality System, Validation, Corrective And Preventive Action.

Who are Drazen Simic's colleagues?

Drazen Simic's colleagues are Susan Stone, Carlos Guerra, Brittany Mathewson, Andreia Pires Ribeiro, Sandra Cron, Tércia Pereira, Kara (Sandler) Rogers.

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