Pharmacist as Scientist (m/f/d)

About Tubulis
The development of novel, effective, and safe therapies for the treatment of cancer is one of the main challenges for modern medicine. We want to drive this process forward. The main goal of Tubulis is to become a leading company in the field of targeted therapeutics and antibody-drug conjugates (ADCs). With a strong team, our own technologies, and innovative therapeutic concepts, we are ushering in a new era in the ongoing fight against cancer and share the vision of helping patients world-wide.

(Associate) Scientist – Biospecimen Part-time position (at least 20h/week) (f/m/d)

On site, remote

BULK DRUG SUBSTANCE / BULK DRUG PRODUCT / IMP SUPPLY CHAIN MANAGEMENT

• Logistical management of the supply chain
• Oversee and manage the BDS and BDP international shipments and inventory by coordinating with CMOs and CPO (Contract Packaging Organization)
• Responsible for maintaining inventories across GMP components
• Oversee vendors´ inventory system (e.g., CPO´s dedicated systems)
• Oversee and manage IMP shipments to site in collaboration with internal Labelling and Packaging lead / PM, internal Clinical Operations team and external CPOs
• Take responsibility as IoR for international shipping
• Support timelines shipment of intermediates across the network of GMP suppliers; coordinate with internal area leads and internal and CMO´s project managers
• Oversee and manage controlled shipments to license partners
• Contribute to evaluating shipment exceptions / excursions and deviations in collaboration with QA and internal SMEs

LABELLING & PACKAGING / IMP LIFECYCLE

• Lead aspects of Labelling and Packaging activities such distribution planning
• Conduct IMP reconciliation in collaboration with Clinical Operations

BIOSPECIMEN / CLINICAL SAMPLES

• Oversee and manage the complete lifecycle of biospecimens (blood and tissue samples) collected for clinical studies
• Responsible for biospecimen management-related activities such as overseeing sample processing documentation and query / deviation reporting
• Responsible for performing routine management activities, such as creating and maintaining inventory files to facilitate specimen tracking using various tracking tools
• Able to prepare communication plans to enable study leads to deliver samples to appropriate analysis vendors on time, and to follow up on active issues with vendors
• Collaborate with Clinical Operations, Project Management and Quality in the selection of central laboratories, e.g., biospecimen and clinical sample long-term storage
• Able to identify biospecimen-related risks and mitigation strategy proposals

• Bachelor´s degree or equivalent professional training and relevant formal academic qualification
• AND 3+ years of academic, biotech, healthcare, or pharmaceutical industry experience, or equivalent
• Preferred experience: biospecimen lifecycle / operations, compliance, management and vendor management
• Technical know-how to create tools to solve operational challenges and improve workflows
• Working knowledge of biospecimen management for clinical trials, familiarity with relevant FDA and ICH / GCP regulations
• Basic understanding of clinical and biomedical research, GMP, GDP, GCP, GLP CLIA, data management, risk management, and regulatory issues
• Basic understanding of import / export customs requirements for international shipment
• Ability to effectively communicate, create and deliver presentation / information / data to knowledgeable audiences

Flat hierarchies and short decision-making processes; open corporate culture; possibility of partial home office; unlimited contract after probationary period; 30 days\‘ vacation; strong team spirit; personal appreciation of values; multicultural and global team and high level of collegiality; regular team events; mobility allowance; Group accident insurance, pleasant office atmosphere, modern technology standard.