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Hello, I'm
Ondrej Julinek

Independent Quality Consultant

About me

  • Name: Ondrej Julinek, Ph.D.
  • Email: julinek@iqconsult.eu
  • Phone: +420 602 46 48 84
  • Location: Brno, Czech Republic

Professional Profile

Analytical chemist who started his professional career in the field of specialized spectroscopic techniques but was soon attracted by the world of chromatography.

Always looking forward to performing difficult tasks, solving complex analytical issues, learning new things and applying them to improve quality and efficiency of the analytical work.

My professional career started in a cGMP-compliant analytical CRO where I had the chance to master various analytical techniques and perform most difficult research and development projects. After 7 years on the position of the Head of Analytical R&D I decided to take up another challenge in my professional life and to offer my services as an Independent Quality Consultant, providing expertise for CMC area, with special focus on Accelerated Stability Assessment Program (ASAP) technique.

My Services

Overview of services I provide


Implementation of ASAP

Introduction of procedures and workflows to establish the system for quick and efficient determination of drug substance or drug product shelf-life by the Accelerated Stability Assessment Program (ASAP) approach which provides significant time and cost savings in the product development.

  • I implemented the ASAP technique into an analytical CRO and was then responsible for improvements of the instrumentation as well as the project workflows to increase ASAP project efficiency. During the past 10 years, I have performed and supervised multiple ASAP studies, including both liquid and solid dosage forms.

Support for ASAP studies

Providing support for Accelerated Stability Assessment Program (ASAP) studies, which may be helpful especially to new users of ASAP. Assuring that the studies are designed, performed, evaluated and their results interpreted correctly.

  • In the last 10 years, I have been involved in numerous ASAP studies, dealing with various liquid and solid dosage forms with diverse shelf-life limiting quality attributes, covering both chemical and physical change. Expert support for the first ASAP studies assures correct performance and significantly increases the chance of successfully implementation of the technique.

Training of ASAPprime® Users

Instruction of ASAPprime® software users on the application and usage of the software, scientific background of the Accelerated Stability Assessment Program (ASAP) approach and practical aspects of the ASAP-related laboratory work.

  • I was trained and authorized by FreeThink Technologies to perform the ASAPprime® training.
    During the past 4 years, I have performed the ASAP training of more than 20 companies. I have extensive experience with the practical performance of ASAP studies, ASAP theory and usage of ASAPprime® software.

Implementation of OpenLab Chromatography Data System

Support for the implementation of OpenLab Chromatography Data System (CDS) from Agilent. Alignment of the program workflow and operating procedures of the company to set processes which are most effective while compliant with the data integrity regulatory requirements. Proposal of user groups and their roles to establish functional hierarchy compliant with the structure of the company and its defined procedures, adjustment of the reports to provide results in practical and well-arranged format. Serving as a mediator and coordinator between the system supplier, IT department, QA department and the operators of the system.

  • I was responsible for the implementation of OpenLab CDS to become a central system for acquisition and evaluation of chromatographic data within an analytical CRO. The first phase of the implementation included extensive testing of the system, preparation of the implementation plan and evaluation of associated risks. The next phase comprised of the establishment of process workflows, customization of report templates and preparation/update of all related standard operating procedures. The last phase covered the training of all users, installation of the software and subsequent troubleshooting and improvement of the system. The whole implementation was performed in close cooperation with other departments (QA, IT) as well as the official supplier of OpenLab CDS.

Analytical method troubleshooting

Solving issues with analytical methods, including on-site investigation in order to reveal the root cause and to find suitable corrective actions to remedy the method performance. Professional support from an independent expert provides an additional and unbiased insight. It can also help to solve any quality-related buyer-supplier disputes.

  • I have extensive experience with investigations of analytical methods the performance of which did not meet the customer's requirements. The process of remedy involved careful investigation of available data, literature review, additional experiments and when the suboptimal method performance was site-specific, also a visit of the laboratory to make an on-site observation.

Expertise for method qualifications, validations and method transfers

Providing expertise for method qualifications/validations to assure the suitability of the qualified method for the given purpose and to comply with all regulatory requirements. Providing support for method transfers, assessment of the transferred methods, evaluation of method transfer risks, supervision of the analytical method transfer. Supervision of the process, support for the related documentation.

  • I supervised numerous qualifications of analytical methods (in-house developed, adopted, compendial) and have extensive experience with analytical method transfers from the perspective of the receiving as well as the sending laboratory.

Support for method development, assessment of method suitability

Providing support for analytical method development, evaluation of analytical methods to assess their suitability for a given application.

  • I have extensive experience with analytical method development (especially HPLC methods, coupled with UV, RI, Corona CAD or MS detector), the complexity of the development ranging from slight adjustments and fine-tuning of existing methods to the method development performed from the scratch.

Impurity profiling expertise

Providing support for projects focused on the determination of the structure of unknown impurities, preparation of optimal and most effective design of forced degradation studies (also performed according to ANVISA requirements).

  • I have experience with projects involving difficult determination of the structure of an unknown impurity which required multi-method approach (analytical HPLC, semi-preparative HPLC, LC/MS and NMR techniques) and various forced degradation studies (studies supplementing method validations, studies compliant with the requirements of the Brazil health authority).

...and much more

The above activities do not represent the complete list of services. Do not hesitate to contact me, I am looking forward to discussing your particular project in detail.

Professional Experience

Overview of experience and skills


Team leading

  • Supervision of the R&D team of analytical specialists and project managers
  • Planning of the R&D resources (human, instrumental)
  • Supervision of all R&D-related laboratory activities

Analytical Support

  • Analytical expert within the investigation group supervising investigations of the Out Of Specification results of GMP analyses within the R&D and QC department
  • Support for difficult and non-standard projects performed by the Quality Control department
  • Analytical expertise and external analytical troubleshooting performed on the customer's site (troubleshooting of analytical methods and procedures, supervision of method transfers, investigation of product non-conformances)

Introduction of new techniques and technologies

  • Implementation of the Accelerated Stability Assessment Program (ASAP) approach focused on the determination of the shelf-life of pharmaceutical substances and formulations within a short time period. Adjustment of the experimental setup, adaptation of the procedures, progressive improvements of the instrumentation.
  • Implementation of a new server-based Agilent OpenLab Chromatography Data System, alignment of the program workflow with the internal processes within the company, preparation of corresponding standard operation procedures, training of personnel, troubleshooting of the system
  • Introduction of semi-preparative and preparative analytical techniques (semi-preparative HPLC, flash chromatography, dry column vacuum chromatography) employed in the processes of determination of structure of unknown impurities or synthesis of reference standards of identified impurities

Main analytical R&D activities

  • Analytical method development, feasibility studies
  • Analytical method validation and verification
  • Difficult method transfers, method transfer troubleshooting
  • Forced degradation studies (also according to ANVISA requirements)
  • Determination of structure of unknown impurities emerging during stability studies by employing LC/MS and NMR techniques
  • Full analytical support for complex projects from the development of the pilot formulation to the routine production of the final product

Activities related to the Quality System

  • Preparation, implementation and cyclic improvement of Standard Operation Procedures (e.g. procedures for verification of analytical methods, validation of analytical methods, integration of chromatographic data or setup and usage of a server-based chromatography data system), review of the existing ones
  • Compilation of Risk Analyses, participation in the processes of Change Control within the company
  • Performance of internal audits
  • Participation in audits of the authorities (Czech authorities for human and veterinary medicines, FDA) and customer's audits
  • Participation in the proposal and implementation of related CAPAs

Independent Analytical
Consultant

2019 - now
Expertise for Accelerated Stability Assessment Program (ASAP) studies. CMC issues troubleshooting. Consultation, support and project management. Expertise in pharmaceutical analytical chemistry.
LUNARIA spol. s r.o.

Head of Analytical R&D

2012 – 2019
Team leading and supervision of the analytical R&D group, management of complex research and development projects, maintaining contacts and communication of the projects with worldwide-located customers, providing analytical expertise, introduction of new techniques and technologies with the corresponding adjustments and improvements of the GMP system.
LUNARIA spol. s r.o.

QC and R&D Employee   

2011 – 2012
Routine analyses, analytical method validation, analytical method development (HPLC, UV-VIS, dissolution methods etc.), analytical support at customer's lab (HPLC method development).

Education

I studied chemistry at the Institute of Chemical Technology in Prague. I chose analytical chemistry as my specialization and joined the laboratory of circular dichroism where I focused on the studies of interactions of chiral molecules by the electronic and vibrational circular dichroism spectroscopy. After finishing my master degree studies, I proceeded with the Ph.D. study in which I combined practical measurement of circular dichroism with the theoretical modelling of the chiroptical properties of molecules.

Institute of Chemical Technology, Prague

Ph.D. in Analytical Chemistry

2006 – 2010
Ph.D. study at the Department of Analytical chemistry in the laboratory of circular dichroism. Ph.D. thesis entitled " Study of Diastereomeric Noncovalent Complexes and their Components by Circular Dichroism Methods" supervised by Prof. Marie Urbanova.
Institute of Chemical Technology, Prague

M.Sc. in Analytical Chemistry

2001 – 2006
Master's degree study at the Department of Analytical chemistry in the laboratory of circular dichroism. Diploma thesis entitled "Study of Self–assembly on Homopolypeptidic Matrices Using Circular Dichroism Spectroscopy" supervised by Prof. Marie Urbanova.

Contact

Address
Ondrej Julinek, Ph.D.
Luzanecka 1889/12, 602 00
Brno - Cerna Pole, Czech Republic
Natural person registered in the Trade
Licensing Register, ID number 08587582
Phone
tel: +420 602 46 48 84
Email
julinek@iqconsult.eu
LinkedIn
ondrej-julinek-b242abb2
If you have any project or analytical issue I can help you with, please do not hesitate to contact me.