Doreen Dunlap
Bad Kreuznach
Summary
To acquire the position of a Global Validation Manager for Animal Health
Overview
22
22
years of professional experience
Work History
Analytical Scientist
Boehringer Ingelheim Vetmedica Inc.
05.2021 - Current
- Developed and validated analytical methods for complex sample analysis.
- Conducted root cause analysis to resolve technical issues in laboratory processes.
- Led cross-functional teams to implement process improvements and enhance productivity.
- Mentored junior scientists on advanced analytical techniques and best practices.
- Collaborated with regulatory teams to ensure compliance with industry standards.
- Developed strong relationships with vendors and suppliers to secure reliable access to high-quality reagents, consumables, and equipment for laboratory operations.
- Managed multiple projects concurrently while maintaining strict deadlines, ensuring timely completion of all assigned tasks.
- Supported quality control efforts by accurately analyzing raw materials, in-process samples, and finished products to ensure compliance with specifications.
- Collaborated cross-functionally with R&D teams to develop innovative solutions for complex scientific challenges.
- Transfer of analytical methods to Argenta, Dundee (CMO)
- Training of technical assistance in analytical methods
- Participated by Pre submission meeting with FDA
- Writing of submission relevant quality documents in GSpecS and VQD (BIRDS)
Technical Assistance Specialist
Boehringer Ingelheim Vetmedica Inc.
02.2019 - 04.2021
- Supporting the Technical Development Team (Velagliflozin cat and horse projects) as analytical specialist
- Led initiatives to improve data accuracy, resulting in enhanced reporting capabilities.
- Managed multiple projects concurrently while maintaining strict deadlines and quality standards.
- Provide analytical and technical expertise to TDT
- Collaborated with cross-functional teams to streamline processes and integrate new technologies.
- Collaborated with production teams to address quality issues and improve operational efficiency.
- Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
- Prepared and reviewed documentation for product registrations and approvals.
- Conducted risk assessments to identify potential regulatory challenges and solutions.
- Improved regulatory compliance by conducting thorough audits and assessments of internal processes.
Tech. Assistant
Boehringer Ingelheim Vetmedica Inc.
09.2009 - 02.2019
- Conducted quality control tests to ensure product compliance with specifications.
- Maintained laboratory equipment, ensuring optimal performance and compliance standards.
- Developed and documented standard operating procedures for testing methodologies.
- Collaborated with cross-functional teams to resolve quality issues effectively.
- Led root cause analysis for non-conformance incidents, implementing corrective actions.
- Developed standard operating procedures to maintain consistency throughout the laboratory processes.
- Participated in regular audits to ensure ongoing compliance with relevant regulatory requirements.
- Projects:
- Vetmedin chewabale tablets
- Semintra oral solution
- Velagliflozin oral solution (10mg/mL)
- Velagliflozin oral solution (15mg/mL)
- Method development HPLC method (Assay and Degradation)
- Performing of stability studies
- Release of clinical trial supply material, excipients and packaging materials
- Transfer of analytical methods to Promeco, Mexico
- Training of laboratory technicians
- Release of clinical trial supply material, excipients and packaging materials
Trainee
Boehringer Ingelheim Vetmedica Inc.
01.2009 - 08.2009
- Analytical Dev. And Quality Control
- Experienced gained in:
- HPLC and BIChrom
- Dissolution
- Karl-Fischer
Trainee
Boehringer Ingelheim Vetmedica Inc.
12.2007 - 12.2008
- Formulation Development
- Support of production of Telmisartan oral solution (Biberach and Ingelheim)
- Experienced gained in:
- Granulation
- Tableting (KORSCH, FETTE)
- IPC for tablets
- Sterile filling machine
Trainee
Boehringer Ingelheim GmbH
11.2006 - 11.2007
- SPIRIVA - Production and packaging site
- Experienced gained in:
- The control of Uhlmann packaging line
- The control of capsule filling machine
Worker
Family business (Restaurant)
05.2003 - 09.2006
Education
Training - Pharmaceutical Technician
Boehringer Ingelheim GmbH
08.2009
Environmental Protection
FH Bingen
04.2003
A-level - undefined
Hildegardis Schule Bingen
08.2001
High School Diploma -
Realschule
Bad Kreuznach08.1998
Skills
- MS Office proficiency
- GSpecS (Keyuser for AH in Ingelheim - Expert)
- Vault Quality Docs (Document Coordinator for ADQC)
- Trackwise (experienced - Investigator training ongoing)
Computer skills:
- Cuka (Keyuser - experienced)
- Effective time management
- Project coordination
- Successful negotiation skills
Additional Trainings in:
Additional Information
Successfully participated in six (6) agency audits and two (2) corporate audits since 2009.
Languages
English
Advanced (C1)
German
Bilingual or Proficient (C2)
Timeline
Analytical Scientist
Boehringer Ingelheim Vetmedica Inc.
05.2021 - Current
Technical Assistance Specialist
Boehringer Ingelheim Vetmedica Inc.
02.2019 - 04.2021
Tech. Assistant
Boehringer Ingelheim Vetmedica Inc.
09.2009 - 02.2019
Trainee
Boehringer Ingelheim Vetmedica Inc.
01.2009 - 08.2009
Trainee
Boehringer Ingelheim Vetmedica Inc.
12.2007 - 12.2008
Trainee
Boehringer Ingelheim GmbH
11.2006 - 11.2007
Worker
Family business (Restaurant)
05.2003 - 09.2006
Environmental Protection
FH Bingen
A-level - undefined
Hildegardis Schule Bingen
Training - Pharmaceutical Technician
Boehringer Ingelheim GmbH
High School Diploma -
Realschule
References
Dr. Sven Anke
Head of Analytical Development and Quality Control, Animal Health,
contact: sven.anke@boehringer-ingelheim.com
Hobbies and Interests
Cooking and Baking:
I have always supported my family business and it was there that I discovered my passion for baking and cooking,
Therefore I always like to share cake.
I also enjoy reading, gardening and spending time with my family and friends
Personal Profile
I am a self-motivated, enthusiastic, reliable and responsible person. I am able to work well both in a team environment as well as using own initiative.