Günther Heinrich
Starnberg
Kurzprofil
Highly accomplished and focused scientist and business professional with a record of achievement in contributing consulting expertise in the international pharmaceutical and biotechnology arenas. Generated quality documentation that led to the DIN EN ISO/IEC 17025 accreditation of a German diagnostic laboratory. Prepared documentation that led to the CE mark of two medical devices for oncology. Responsible for a clinical trial in Heidelberg. Developed the antibody, Simulect, the 4th therapeutic antibody approved by the FDA; lead clinical trials; defined and developed research strategies; and drove the licensing process of numerous biomarkers in North America and Europe. Introduced a drug & a medical device into the Hungarian and Czech markets. Skilled in conducting critical analysis to uncover the scientific potential of novel technologies; facilitated the development and implementation of highly profitable products. Demonstrated strong budgeting and business management expertise, and the ability to inspire and direct the efforts of scientists and staff to realize organizational vision. Author and co-author of 20+ peer-reviewed scientific publications, 22 patents and patent applications. Recipient of several entrepreneurial awards, including second prize in the national StartUp Founders competition in 1998, the German Founders Prize competition in 2002, and finalist in the “Entrepreneur of the Year“ competition. Additional strengths include
Übersicht
40
40
years of professional experience
9952
9952
years of post-secondary education
Berufserfahrung
Consultant
Bachem Bubendorf
2025.05 - 2025.12
- Review of SOPs, part lists, maintenance lists, IQ and OQ documents
Consultant
Neovii Pharma
Gräfelfing
2024.07 - 2024.12
- Generation of DQ, Risk Analysis, IQ, OQ, PQ protocols of five equipment.
- Validation of Clean Rooms
Consultant
Expert AAA (Novartis)
Ivrea
2023.11 - 2024.06
- Remediation of the company
- Validation of Clean Rooms
- Generation of SOP, FRM, IOQ and IOPQ protocols
- Reduction of Deviations and CAPAs
- Validation of particle counters, microbial particle counters; HPLCs; spectrophotometers, balances
Consultant
Microbiology Alvotec
2023.07 - 2023.08
- Responsible for ensuring GMP compliance in the generation of the new facility
- Review of batch records
Consultant QA
Teva Biotech
Ulm
2022.09 - 2023.06
- Review and approval of validation protocols (Risk analysis, IQ-/OQ-/PQ-Plans and Reports)
- Review of batch records
- Validation of Clean Rooms
- Reduction of Deviations and CAPAs
- Adaptation and creation of documentation with regard to the implementation of data integrity requirements in instruction documents, manufacturing documents as well as analytical documents and SOPs.
Consultant Head of Production
Spitalpharmazie Münsterlingen
Münsterlingen
2022.06 - 2022.08
- Responsibility for the planning, control and monitoring of production processes with a focus on safety, adherence to deadlines and quality
- Leadership of the team of 20 employees
- Review of batch records
- Review of SOPs and of DQ, IQ, OQ and PQ documents
Consultant Head of Deviations and CAPAs
Aenova Pharma
Wolfratshausen
2021.09 - 2022.05
- Reduction of Deviations and CAPAs
- Generation of SOPs as well as Risk Analysis, DQ, IQ, OQ und PQ documents
- Introduction of DHC Vision Software
Consultant (Head QA)
Sartorius Stedim Biotech GmbH
Göttingen
2020.08 - 2021.07
- Responsibility for the planning and monitoring of production processes
- Performance of internal and supplier audits
- Preparation of audit documentation
- Preparation of documents for the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)
- Preparation of documents for the U.S. Food and Drug Administration (FDA)
Consultant
Puren Pharma GmbH
Munich
2020.01 - 2020.03
- Control of patient information leaflets
Consultant
UL Healthcare and Life Sciences GmbH
Ochsenhausen
2019.04 - 2019.11
- In addition, SOPs had to be revised and new SOPs had to be written for the approval of new tests
- Generation of DQ, IQ, OQ und PQ documents
Consultant
Roche Diagnostics
Mannheim
2018.09 - 2019.03
- Analysis of medical device documentation and suggestions for improvement
- Revision and re-writing of SOP documents for medical devices
- Processing of CAPA Quality Control
- Implementation and completion of CAPA monitoring
Consultant
Takeda GmbH
Singen
2017.06 - 2018.07
- Evaluation of the production and revision of the documentation of freeze-dried drugs
- Suggestions for corrective and preventive measures
- Initiation of CAPAs
- Revision of the documentation for the production of freeze-dried medicines
- Troubleshooting and process optimization for the filling process
- Contribution to an optimized production and documentation
Head of Operations & QM
Sartorius Stedim Cellca
Laupheim
2016.03 - 2017.05
- Introduced improved QM standards for the antibody cell line production
- Improved QM System for the control of every production step
- Establishment of documentation control
- Adapted SOP System to reduce variation in the production
- Reviewed DQ, IQ, OQ and PQ documents
- Improved Corrective Action/Preventive Action (CAPA) System to eliminate causes of non-conformities or other undesirable situations
- Introduced measures aimed to prevent the occurrence (preventive action) and recurrence of non-conformities (corrective action)
- Performed mutual and beneficial audits to the company
- Non-conforming product control was performed through the supplier's audit
- Implementation of a business management review
- Streamlined the QM system and the production process
- Evaluated new diagnostic equipment
- Surpassed the production goals by 50%
Consultant
Bahrain Development Board
2015.09 - 2016.02
- Analyzed the diagnostic market in the GCC region
- Wrote a business plan for the establishment of molecular laboratories in the GCC region
Head of QM
Hospital in Prien
Prien
2014.04 - 2015.07
- Performed diagnostic tests for instance HPLC and Elisa Assays for the successful CE marking
- Wrote required documents (SOPs and Quality Management Handbook) for the CE marking of two medical devices according 13485 and class IIB in the area of oncology for the Notified Body's and the US FDA GMP Audits to QSR 21 CFR Part 820
- Performed internal trainings and audits
Business Development Director
Biofrontera AG
Leverkusen
2013.02 - 2014.02
- Introduced a novel drug & a medical device for a German dermatology company into the Hungarian and Czech market
- Identified key opinion leaders and distributors
- Developed marketing strategy and clarified reimbursement with local authorities
Clinical Trial Director
Biopheresis GmbH
Heidelberg
2011.03 - 2013.01
- Planned and managed a clinical oncology trial in Heidelberg, Germany
- Set-up and maintained project files
- Set-up and maintained investigator files
- Prepared regulatory binders (Study File Notebooks) for study sites
Chief Operating Officer
BioPheresis Technologies GmbH
Heidelberg
2007.01 - 2011.01
- Championed research and development efforts for this medical device company focused on tumor immunotherapy.
- Defined corporate strategies to facilitate continued growth and profitability.
- Identified cost savings opportunities and substantially improved profit margin.
- Drafted and continuously monitored the business plan to meet with the changing market environment.
- Established a novel rat tumor apheresis model.
- Established a collaboration with Prof. Eggermont, Clinical Director General Director of the Intitut de Cancérologie Gustave Roussy (IGR, Villejuif) resulting in a patent application.
- Led the company’s efforts in obtaining the CE mark for its immune-absorption column OncoSorb utilized for the treatment of metastatic cancers.
Founder and CEO
PharmTech Solutions
Starnberg
2005.01 - 2007.01
- Authored grant proposals for three German biotechnology companies, which resulted in €2.5 million in funding by the Ministry of The Environment of Lower-Saxony, Germany.
- Founded and launched a life sciences consulting company.
- Developed and implemented corporate strategies for vaccine, biomarker, and biotechnology companies.
- Analyzed clients’ R&D efforts and provided ongoing advisory services to drive productive efforts.
- Advised and authored a business plan for a German start-up company, resulting in a term sheet for a €5 million investment.
- Analyzed, monitored, and reviewed innovative research and technological development projects for the medical device industry as an accredited consultant of the EU; total grants exceeded €100 million.
- Served as a consultant for Apeiron Partners LLC, an investment bank in Framingham, Massachusetts; consulted for Sultan Qaboos University’s College of Medicine in Muscat, Oman.
- Successfully established a plan to align and refocus development efforts for an Austrian vaccine company.
- Initiated cost reduction and business restructuring efforts for a life sciences company in Potsdam. Analyzed products, patents, and technologies.
Executive Vice President, Biomarkers
Protana Inc.
Toronto
2004.01 - 2005.01
- Refocused biomarker R&D efforts for this proteomics company acquired by Transition Therapeutics Inc., in 2005.
- Initiated corporate deals and introduced standard operating procedures related to diagnostic biomarker analysis.
- Concluded a corporate deal with Insception Biosciences Inc., in Ontario in the area of stem cell biomarker assay discovery and development.
- Initiated and closed a deal with Neurocrine Inc. a company focused on developing drugs for neurological and endocrine diseases.
- Spearheaded efforts and obtained a biomarker assay license from the University of Göttingen, Germany.
- Instituted effective cost reduction measures after review of its operations with a view to maximising future profitability.
- The implementation of increased operational efficiencies and a combination of head count and overhead reductions resulted in increased efficiencies and savings of 25%.
Founder & CEO
EPIDAUROS Biotechnologie AG
Bernried (Munich)
1997.01 - 2003.01
- Conceptualized and developed the corporate strategy as part of launching one of the world’s first biomarker companies what is now part of Beckman Coulter, Inc.
- Epidauros´ service business represents a leading pharmacogenetic research organization (PRO) delivering innovative and integrated premium solutions, from sample preparation to clinically relevant output.
- Prepared all business documents required for the company’s listing on the Frankfurt Stock Exchange.
- Executed the successful sale of the company to a private investor in 2003.
- Grew the company from zero to 61 staff and from €15 million raised from VC funding to €190 million over 5 years.
- Raised capital from 3i, DEWB, Bayern Capital, and TBG; completed road show activities in Frankfurt and London.
- Championed the creation and implementation of a research strategy, which resulted in the discovery of the first biomarker in a drug transporter (MDR1), 19 patent applications for DNA-based biomarker assays, and several awards, including the prestigious Prix Galien and the Bard award.
- Spearheaded the GLP and ISO 9001 certification efforts.
- Contributed to budgeting and forecasting efforts.
- Initiated, structured, and executed deals with international pharmaceutical and diagnostic companies, including Pharmacia Corp. (now Pfizer), Johnson & Johnson, Parexel, Novartis, Sankyo Pharmaceuticals, and Sankyo Europe, among others.
- Established collaborations with universities and hospitals in Europe, the US, and Korea, including Biozentrum, Georgetown University, Charité, and University Hospital of Pousan.
- (purchased by Forest Labs)
Co-Founder & Vice President, Business Development
Variagenics, Inc.
Cambridge
1993.01 - 1997.01
- Participated in developing the corporate strategy that resulted in the launch of this cancer company that merged with Hyseq and became Nuvelo (now ARCA Biopharma, Inc.), a publicly traded biopharmaceutical company dedicated to improving the lives of patients through the discovery, development, and commercialization of novel drugs for acute cardiovascular disease, cancer, and other debilitating medical conditions.
- Contributed to the creation of the strategic plan, resulting in generating more than $11 million in VC funding.
- Developed the biomarker-based cancer strategy, and generated deals with Isis Pharmaceuticals, and Hybridon.
- Licensed the MTHFR biomarker assay from McGill University.
- Developed and instituted the research strategy, which resulted in 3 patents.
- (Now ARCA Biopharma, Inc.)
Visiting Scientist
Massachusetts Institute of Technology
Cambridge
1992.01 - 1993.01
- Conducted cancer research in Professor David Housman’s laboratory on sabbatical leave from Sandoz Ltd. (now Novartis).
- Research Project: Characterization of the Wilms Tumor Suppressor Gene Product.
Group Leader
Sandoz Ltd. (Now Novartis)
Basel
1986.01 - 1993.01
- Developed the antibody drug Simulect used for the prophylaxis of acute organ rejection in patients receiving renal transplants; collaborated with the Royal Free Hospital in the creation of the antibody, which was the fourth antibody to be approved by the FDA.
- Simulect generated sales of $1.2 billion in 20016.
- Cloned the mouse variable region genes, combined these genes with human constant region genes and improved the expression of the chimeric antibody.
- Wrote patents and all documentation necessary to commence clinical trials.
- Co-authored the NDA application.
- Succeeded in cloning and expressing the Insulin-like Growth Factor Binding Protein (IGF-BP2).
- Led a team of 15 scientists, including graduate students and postdocs.
Ausbildung
Training as QM Specialist, QM Representative and QM Auditor -
<ul><li>T</li><li>V Süd</li></ul>
MunichExecutive MBA -
UNIVERSITY OF CHICAGO GRADUATE SCHOOL OF BUSINESS
ChicagoPostdoctoral Training - Expression of Immunoglobulin Genes in E. coli
HARVARD UNIVERSITY
Cambridge 1982.01 - 1984.01
Ph.D. - Structure and Organization of Murine Immunoglobulin Light Chain Genes
BIOZENTRUM OF THE UNIVERSITY OF BASEL
BaselMaster of Science - Cloning of the Murine T-Cell Receptor
BASEL INSTITUTE FOR IMMUNOLOGY
BaselMaster Program in Biology -
UNIVERSITY OF FREIBURG
FreiburgKompetenzen
- Quality Management
- Diagnostic & Drug Development
- Clinical Trials
- Oncology
- Endocrinology
- Antibody Expertise
- Corporate Negotiations
Benutzerdefiniert
- Second prize, German Founders Prize competition (Deutscher Gründerpreis), 2002, Sponsored by McKinsey Consulting, the German Savings Banks, the magazine Stern and the German TV channel ZDF
- Finalist in the competition “Entrepreneur of the Year“, 2001, Sponsored by Cap Gemini, Ernst & Young, the Deutsche Bank, SAP, the German Stock Exchange, the Manager Magazine and the Frankfurter Allgemeine Zeitung
- Prix Galien Germany, Award for the Advancement of Pharmacological Research in Germany (EPIDAUROS), 2001
- BARD Prize of the German Society of Urology (EPIDAUROS), 2000
- Member of the Scientific Advisory Board of BRUKER DALTONICS, 2000-2003, Billerica, Massachusetts
- Winner of the Bavarian StartUp Founders competition and 2nd prize in the national StartUp Founders competition, 1998, Sponsored by McKinsey Consulting, the German Savings Banks and the magazine Stern
- 2nd prize in the Douglas Prize MBA competition, 1997, Sponsored by Babson College, Wellesley, Massachusetts
Languages
German, English
First languages
French
Intermediate
B1
Zeitleiste
Consultant
Bachem Bubendorf
2025.05 - 2025.12
Consultant
Neovii Pharma
2024.07 - 2024.12
Consultant
Expert AAA (Novartis)
2023.11 - 2024.06
Consultant
Microbiology Alvotec
2023.07 - 2023.08
Consultant QA
Teva Biotech
2022.09 - 2023.06
Consultant Head of Production
Spitalpharmazie Münsterlingen
2022.06 - 2022.08
Consultant Head of Deviations and CAPAs
Aenova Pharma
2021.09 - 2022.05
Consultant (Head QA)
Sartorius Stedim Biotech GmbH
2020.08 - 2021.07
Consultant
Puren Pharma GmbH
2020.01 - 2020.03
Consultant
UL Healthcare and Life Sciences GmbH
2019.04 - 2019.11
Consultant
Roche Diagnostics
2018.09 - 2019.03
Consultant
Takeda GmbH
2017.06 - 2018.07
Head of Operations & QM
Sartorius Stedim Cellca
2016.03 - 2017.05
Consultant
Bahrain Development Board
2015.09 - 2016.02
Head of QM
Hospital in Prien
2014.04 - 2015.07
Business Development Director
Biofrontera AG
2013.02 - 2014.02
Clinical Trial Director
Biopheresis GmbH
2011.03 - 2013.01
Chief Operating Officer
BioPheresis Technologies GmbH
2007.01 - 2011.01
Founder and CEO
PharmTech Solutions
2005.01 - 2007.01
Executive Vice President, Biomarkers
Protana Inc.
2004.01 - 2005.01
Founder & CEO
EPIDAUROS Biotechnologie AG
1997.01 - 2003.01
Co-Founder & Vice President, Business Development
Variagenics, Inc.
1993.01 - 1997.01
Visiting Scientist
Massachusetts Institute of Technology
1992.01 - 1993.01
Group Leader
Sandoz Ltd. (Now Novartis)
1986.01 - 1993.01
Postdoctoral Training - Expression of Immunoglobulin Genes in E. coli
HARVARD UNIVERSITY
1982.01 - 1984.01
Training as QM Specialist, QM Representative and QM Auditor -
<ul><li>T</li><li>V Süd</li></ul>
Executive MBA -
UNIVERSITY OF CHICAGO GRADUATE SCHOOL OF BUSINESS
Ph.D. - Structure and Organization of Murine Immunoglobulin Light Chain Genes
BIOZENTRUM OF THE UNIVERSITY OF BASEL
Master of Science - Cloning of the Murine T-Cell Receptor
BASEL INSTITUTE FOR IMMUNOLOGY
Master Program in Biology -
UNIVERSITY OF FREIBURG