Angela Koller
Biberach
Summary
Experienced leader with strong background in guiding teams, managing complex projects, and achieving strategic objectives. Excels in developing efficient processes, ensuring high standards, and aligning efforts with organizational goals. Known for collaborative approach and commitment to excellence.
Overview
22
22
years of professional experience
Work History
Global Quality Head for Global Innovation, AH
Boehringer Ingelheim Vetmedica Inc.
06.2025 - Current
- Ensuring that all regulated activities within Global Innovation comply with the requirements of the relevant authorities and internal standards
- Implementing and managing the Quality oversight of Global Innovation projects along the development phases until product launch
- Partnering with the Global Innovation leadership team in establishing the right level of Quality in R&D
- Leading the global Quality team spanning 6 CMC development sites and 5 clinical centers in Europe, US and China
Director Bioprocess Development – Oncology and Digitalization
Boehringer Ingelheim Pharma GmbH&Co.KG
10.2024 - 05.2025
- Accountable for bioprocess development across oncology programs, including cell line development, upstream and downstream process development, spanning all development phases until final submission (BLA)
- Defined and drove the overarching digitalization strategy for Bioprocess Development, covering LIMS implementation, harmonized data standards, process modelling, and automation initiatives
- Led and executed organizational development and change management initiatives within Bioprocess Development, ensuring successful implementation and sustainable adoption
Director Bioprocess Development – Early Stage
Boehringer Ingelheim Pharma GmbH&Co.KG
03.2024 - 09.2024
- Accountable for upstream and downstream bioprocess development for all early stage NBE programs from cell line generation up to late stage clinical development
- Improved successfully the R&D collaboration as chair of the interface group of directors accountable for program transfers from Research to Development
- Improvement of the developability concept to select candidates regarding CMC aspects and improve product quality in close collaboration with the research organization
Director Pharmaceutical Development Biologicals – Early Stage
Boehringer Ingelheim Pharma GmbH&Co.KG
09.2018 - 02.2024
- Accountable for formulation and process development across all early-stage NBE programs, including therapeutic viruses, through handover to the newly created Viral Therapeutic Center (VTC)
- Designed and implemented a new early-stage development platform based on miniaturized high-throughput workflows and statistical methodologies, enabling predictive and data-driven formulation development
- Defined and embedded a drug product developability framework to guide candidate selection from a CMC perspective to improve product quality, in close collaboration with the research organization
- Built up and scaled the newly established Virus Therapeutic Development organization and successfully transitioned leadership to the new management team by March 2022
Director Analytical Development NCEs – Analytical Technologies
Boehringer Ingelheim Pharma GmbH&Co.KG
01.2016 - 08.2018
- Led analytical technologies supporting early- and late-stage drug substance and drug product development across the sites Ingelheim and Biberach
- Provided GMP-compliant release and stability testing for clinical programs
- Served as “Leiter Qualitätskontrolle” in accordance with §§ 4(1) and 12(1) AMWHV
Head of Analytical Development Germany, Biopharma
Boehringer Ingelheim Pharma GmbH&Co.KG
09.2012 - 12.2015
- Accountable for all aspects of analytical development for NBEs, Biosimilars, and CMB projects, from early development through successful BLA submission
- Built and scaled the analytical development organization in Biopharma by doubling headcount and systematically developing capabilities and skills to transform the organization from CMB focus to innovative NBE and Biosimilar development
- Defined successfully the analytical strategies to demonstrate similarity for the newly formed Biosimilar business to reach FDAs approval for the concept
- Served as primary interface with regulatory authorities, leading scientific discussions on analytical strategies for Biosimilars and NBEs
- Appointed Head of Quality Control (“Leiter Qualitätskontrolle”) in accordance with §§ 4(1) and 12(1) AMWHV
Head of Quality Control
Acino AG
11.2011 - 08.2012
- Successfully led the site to FDA inspection readiness
- Responsible for Quality control of incoming goods, packaging material, intermediates, clinical trial material and finished product (patches and implants)
- Appointed "Leiter Qualitätskontrolle" according to §§ 4 (1) und 12 (1) AMWHV
- Lead the Quality Control department at the site
Head of Analytical Development
Roche Diagnostics GmbH
12.2007 - 10.2011
- Led and transformed Analytical Development at the Mannheim site from a local organization into a headquarters-centered matrix organization through to site closure
- Accountable for the development and validation of analytical methods for parenteral dosage forms supporting late-stage development and life-cycle management of NBE and NCE programs
- Appointed LQK (“Leiter Qualitätskontrolle”) and QP (Qualified Person) for clinical supplies according to §§ 4 (1) und 12 (1) AMWHV
Head of Lab Analytical Development
Roche Diagnostics GmbH
06.2004 - 11.2007
- Analytical lead in late stage development projects
- Lab head in Analytical Development of parenterals
Education
PostDoc - Department of Pharmacology
TU München
05.2003
PhD studies - Department of Pharmacology
TU München
07.2002
Studies of Pharmacy, Approbation -
LMU München
12.1998
Skills
- Empathic leader and certified coach with the ability to drive change and delivering measurable organizational impact in complex, international environments
- Proven CMC development expertise across diverse modalities, supported by broad end‑to‑end development and quality experience
Timeline
Global Quality Head for Global Innovation, AH
Boehringer Ingelheim Vetmedica Inc.
06.2025 - Current
Director Bioprocess Development – Oncology and Digitalization
Boehringer Ingelheim Pharma GmbH&Co.KG
10.2024 - 05.2025
Director Bioprocess Development – Early Stage
Boehringer Ingelheim Pharma GmbH&Co.KG
03.2024 - 09.2024
Director Pharmaceutical Development Biologicals – Early Stage
Boehringer Ingelheim Pharma GmbH&Co.KG
09.2018 - 02.2024
Director Analytical Development NCEs – Analytical Technologies
Boehringer Ingelheim Pharma GmbH&Co.KG
01.2016 - 08.2018
Head of Analytical Development Germany, Biopharma
Boehringer Ingelheim Pharma GmbH&Co.KG
09.2012 - 12.2015
Head of Quality Control
Acino AG
11.2011 - 08.2012
Head of Analytical Development
Roche Diagnostics GmbH
12.2007 - 10.2011
Head of Lab Analytical Development
Roche Diagnostics GmbH
06.2004 - 11.2007
PostDoc - Department of Pharmacology
TU München
PhD studies - Department of Pharmacology
TU München
Studies of Pharmacy, Approbation -
LMU München
Professional Trainings and additional experiences
- Team Coaching certificate: professional training, April 2025 – November 2025, Hephaistos Coaching Zentrum München, certified by DBVC (Deutschen Bundesverband Coaching e.V.) and IOBC (International Organization for Business Coaching)
- Coaching certificate: professional training, July 2022 – Sept 2024, Hephaistos Coaching Zentrum München, certified by DBVC (Deutschen Bundesverband Coaching e.V.) and IOBC (International Organization for Business Coaching)
- Mentoring: internal mentoring of talents in independent functions
- Senior Leadership Programs: Engage Womens Leadership, BI Development Center, Connectivity (Korn Ferry, DUKE University, London Business school)
- Leading Change:
- 2025: Animal Health Ahead, implementation in GIQA
- 2023 – 2024: Organizational Health Dev Bio
- 2018 – 2022: Cultural Transformation in Development Biologicals
- 2016 – 2018: role out of the newly created corporate culture “OurFocus”, VTI “Value Trough Innovation”
- 2012 – 2015: Organizational Development in BioPharma, lead of OD Q-Labs
- Design Thinking Training: Brainbirds GmbH, München
- Basis training: Agile methods for creative work and accelerated projects, brainbirds GmbH, München
- Six Sigma: Yellow Belt Training
- Conferences: Biotherapeutics Analytical Summit, Drug Delivery & Formulation Summit
- Internal and external GMP trainings regarding the role as LQK and QP according to German and European law