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.

Supply Manager - GMP CMC and GCP Biospecimen
Part-time position (at least 20h/week) (f/m/d)
On site, remote

Tasks:

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
Troubleshoot routine problems and understand when escalation is appropriate
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
Troubleshoot routine problems and understands when asking for guidance is appropriate

Requirements:

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

We offer

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.

We look forward to receiving your application with details of when you can start and your salary expectations by email - more information at www.tubulis.com.

Tubulis GmbH
Am Klopferspitz 19 a
82152 Planegg-Martinsried
Germany
www.tubulis.com

Jetzt bewerben

Vollzeit / Teilzeit , Festanstellung

Fachkraft

Aktualisiert am 05.03.2025

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Standort der Stelle

Butenandtstr 1

81377 München

Bayern

Deutschland

Am Klopferspitz 19a

82152 Planegg

Bayern

Deutschland

Home Office (optional)

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