13.07.2026 aktualisiert

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GMP Consultant | interim Management | Pharma-Analysis Expert

Düren, Deutschland
Deutschland +15
info: Deutschland, Österreich, Schweiz, Spanien, Italien, Frankreich, Belgien, Dänemark, Estland, Finnland, Lettland, Litauen, Niederlande, Norwegen, Portugal, Schweden
PhD in Chemical Engineering, Imperial College London
Düren, Deutschland
Deutschland +15
info: Deutschland, Österreich, Schweiz, Spanien, Italien, Frankreich, Belgien, Dänemark, Estland, Finnland, Lettland, Litauen, Niederlande, Norwegen, Portugal, Schweden
PhD in Chemical Engineering, Imperial College London

Profilanlagen

20260708_CV_Daniel_Kune.pdf

Über mich

More than 20 years experience in, and with the pharmaceutical industry sharpened my problem detection and problem solving skills. With its unique microkosmos of rules and obligation in Pharma it is nescessary to have expert knowledge while always understanding the big picture.

Skills

LaboranalysenGmp-gerechte DokumentationAnalyse der Schwachstellen
Pharma-Analysis
Over 20 years of experience in pharmaceutical analysis, including HPLC assay-purity analysis, dissolution, content uniformity, method development and validation according to ICH Q2 (R1) for drug substances and drug products, both under GMP and non-GMP conditions.

GMP Compliance & Quality Control
More than 10 years of expertise in GMP-regulated environments, including fulfilling responsibilities as Head of Quality Control for drug substances and drug products according to §12 AMWHV in German law, obtaining GMP certificates, and overseeing all analytics needed for production.

Personnel & Leadership Responsibility
Over 15 years of personnel responsibility across multiple organizations, including leading interdisciplinary teams, managing up to 12 staff members, and heading departments and divisions at vorious companies.

Budgetary Responsibility
More than 15 years of budgetary responsibility across various companies.

Business Development & Sales
Over 10 years of experience in business development and sales for complex and sophisticated products in the pharma, bio-pharma, food, and chemistry sectors, including import/export activities and strategic investment negotiations.

Project Management
More than 6 years of project management experience, including multi-project planning, coordination with R&D managers, and successful implementation of IQ/OQ/PQ validation projects.

Qualification of Equipment
Hands-on experience with equipment qualification at GenMar and Lyomark, including IQ/OQ/PQ processes and validation of analytical methods and equipment in GMP-regulated laboratory environments.

Strategic Business Development
Four years of strategic business development experienc, focusing on market expansion, customer base growth, and development of new analytical products and services.

Process Qualification & Validation
Four years of experience in process qualification and validation at GenMar and Lyomark, including method validation, process transfers to new CDMOs, and regulatory compliance for drug substances and drug products.

IT & Laboratory Software
Confident handling of all Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and experienced working knowledge with common lab software such as Agilent ChemStore and ChemStation.

Erfahrung

Berufserfahrungmehr als 10 Jahre
Freelancer seit2026

Sprachen

DeutschMutterspracheEnglischverhandlungssicherNiederländischverhandlungssicherSpanischGrundkenntnisse

Projekthistorie

General Manager / Consultant

Kune Consulting GmbH, Dueren, DE
Establishment of a German GmbH to support clients with GMP compliant processes. Project: interim management of an analytical GMP-lab.

Head of QC

GenMar Pharma GmbH, Oberhaching, DE
Set up the QC lab for API and end products, obtained necessary permits (GMP, animal testing, import), ran routine analysis and oversaw all analytics needed to enable production. Fulfilled responsibilities as head of quality control for DS and DP according to §12 AMWHV. Finalized establishment of an animal testing lab under GMP and expanded it to physical/chemical tests. Finalized method establishment and validation of all analytical methods for incoming goods, in-process control, release and stability analysis.

Head of QC / Head of pharm. Dev.

Lyomark Pharma GmbH, Oberhaching, DE
Transfer of multiple processes to new CDMOs, set up of an animal testing lab, obtained GMP certificate. Fulfilled responsibilities as head of quality control for DP according to §12 AMWHV. Accompanied or facilitated multiple process transfers including process and method validation for drug products to new CDMOs. Set up an animal testing lab under GMP and later expanded it to physical-chemical tests. Re-developed a legacy DS production process focusing on scale up and regulatory compliance.

Division Head Innovationslabor

Labor LS SE & Co KG, Bad Bocklet, DE
Establishment and operation of an innovation-hub with the strategic aim to develop new analytical products to be transferred to routine GMP-divisions of the company. Managed interdisciplinary personnel and projects across different divisions and levels of hierarchy. Successfully implemented IQ/OQ/PQ validation of a rapid microbial detection method. Handled client projects regarding microbial and molecular biology analysis.

Sales Manager

CBC-Europe GmbH, Duesseldorf, DE
Sales and import/export of fine chemicals and support with the company's mergers and acquisition activities, supplying scientific and economic analysis to higher management. Participated in take-over and strategic investment negotiations. Conducted pro-active sales including import/export to clients in food, chemistry, pharma and nutraceuticals sectors.

Sen. Business Development Manager

DAISO Fine Chem GmbH, Duesseldorf, DE
Responsibility for business development for a Japanese parent company regarding silica-based chromatography-media in bulk in the region EMEA. Skilled intercultural interactions with Japanese superiors and colleagues. Sales to and education of clients in need of chromatography material (stationary phases).

Director / COO

Stagroma AG, Reinach, CH
Operative management of YMC-Distributor Stagroma AG while simultaneously increasing the presence with the customer base in Switzerland, thereby increasing sales and revenue. Achieved significant increase in turnover. Operational and commercial responsibility including personnel management (3-4 persons). Guided and supported mostly pharma clients with HPLC method development throughout Switzerland.

Business Development Manager EMEA

YMC-Europe GmbH, Dinslaken, DE
Business development and increase of sales for chromatography-bulk-material with clients from the pharmaceutical and bio-pharmaceutical industry. Sales and marketing for complex and sophisticated products. Commercial/budget responsibility for department Prep-LC. Successful presentations in front of audiences up to 100 persons.

Interim Head of R+D

SynCo Biopartners, Amsterdam, NL
Hired as Scientist with tasks of interim head of department APD added to the role. APD had a headcount of 12 persons and was central to the CMO. Developed USP/DSP processes and analytical methods for client projects in the area of therapeutic proteins. Crisis and personnel management during restructuring efforts. Successful execution of projects in downstream processing and development of analytical methods for bio-pharma products.

Project Manager pharmaceutical analysis

Synthon B.V., Nijmegen, NL
Management of a group of 3-5 lab-technicians, initially in analytical R&D, then starting 04/2005 change to (c)GMP based analytical development work including validation projects for drug substance and drug product. Analytical method development and execution including HPLC assay-purity analysis, dissolution, content uniformity. Commissioning and supervising method validation according to ICH Q2 (R1). Personnel and resource management with constantly changing priorities.

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