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Lab Head (m/f/d) in vitro DMPK
* Full Time
* Berlin, Deutschland
* With Professional Experience
* 11/25/25
We are seeking a hands-on, scientifically driven leader to head our pre-/non-clinical in vitro DMPK laboratory. You will oversee a team of 2-4 lab technicians, ensure high assay performance, introduce innovative methodologies, and serve as the DMPK representative in cross-functional drug discovery and development teams, The role combines operational lab leadership, scientific excellence, client interaction, and regulatory-quality documentation.
RESPONSIBILITIES
* Lead and develop a high-performing in vitro DMPK team (2-4 technicians); plan, coordinate and optimize day-to-day lab operations and resource allocation
* Design, execute, troubleshoot, and report routine and advanced in vitro ADME/DMPK studies, including:
o Transporter assays (uptake/efflux, drug-drug interaction risk evaluation)
o Permeability and stability assessments
o Protein binding and whole blood distribution
o Enzyme phenotyping, CYP inhibition and induction
o Microsomal and hepatic clearance studies
* Ensure high data quality and assay robustness across manual and automated workflows; drive continuous improvement of methodologies and SOPs
* Evaluate, implement, and validate new technologies to advance in vitro DMPK capabilities; champion workflow automation where impactful
* Integrate in vitro findings with in vivo PK data to inform project decisions; act as DMPK representative in cross-functional teams
* Author, edit, and contribute to study reports and regulatory documents (e.g., Investigator's Brochure, IMPD, IND, CTD); maintain compliant quality documentation (SOPs, audit-ready records)
* Support client interactions: prepare and deliver presentations, host customer visits, and contribute to audits
* Contribute to budget planning at group project level, monitor spend against plan
* Ensure compliance with applicable regulations and guidelines (GxP principles, health and safety, environmental protection, radiation protection as applicable) and with EMA, FDA, and ICH guidance relevant to in vitro DMPK and drug-drug interaction evaluation
QUALIFICATIONS
* Ph.D. (or equivalent) in life sciences (chemistry, biochemistry, pharmacy) and postdoctoral experience
* Hands-on DMPK/ADME experience in pharma, biotech, or CRO environment, including leading small to mid-sized teams
* Deep knowledge of drug metabolism, enzymology, absorption, distribution, and in vitro ADME development processes
* Strong understanding of R&D practices; familiarity with cellular/molecular biology and chemistry relevant to in vitro DMPK
* Proven experience with quantitative bioanalytical methods (LC-MS/MS; HPLC with radio detection)
* Experience with PK/PD modeling and simulation tools (Phoenix WinNonlin, SimCYP, GastroPlus) is beneficial but not required
* Thorough knowledge of international regulatory principles and health authority guidelines (EMA, FDA, ICH), particularly for in vitro DMPK and DDI evaluation
* Excellent communication and presentation skills; collaborative, self-driven, and results-oriented; adept at building relationships internally and externally
* Track record in authoring study reports and submission-relevant dossiers
* Fluent German and English (written and spoken)
WE OFFER
* Opportunity to shape and scale in vitro DMPK capability with tangible impact on discovery and development decisions
* A collaborative, cross-functional environment with strong scientific standards
* Competitive compensation and benefits aligned with experience and responsibility
* Unlimited contract, 30 days holiday per year, flexible working hours, including a modern workplace
* Company pension scheme and health prevention offers
* Comprehensive introduction and individual training and development
* BVG job ticket and free parking spaces directly on-site
Contact person
Rosa Tuna-Lavaccara
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