Team Leader QC Raw Materials (f/m/d)

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market.

Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia.

As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies.

We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

Summary

At our Heidelberg site we are looking for a Team Leader of the QC Raw Material department. The department is mainly responsible for tests and releases of raw materials and consumables for GMP production for early and late phase projects.

Next to the daily people management, the focus in this position is set on teamwork, continuous improvement of processes, coordination and strong communication with external vendors and related departments like QA, supply chain and production.

Do you want to set the future direction for our QC Raw Material group? If you are an experienced leader or want to take the next step in your career, then come and join us ensuring continuous improvement and on time delivery of material release for our products.

Job Responsibilities:

Oversight of QC Raw Materials Group
Leading a Team of 5 employees
Release of raw materials and consumables for GMP production
Coordination of material qualification programs with external vendors
Oversight of relevant equipment including support of qualification
Oversight of relevant items in the document management system (DEV, CAPA, CR, SOPs)
Continuous improvement of departmental and cross-departmental processes (e.g throughput times, application of lean principles, communication strategies)
Harmonization of material qualification programs in coordination with Corporate Quality and the international AGC Biologics network
Support CAPEX process for relevant equipment
Support laboratory investigations
Support for Audits and Inspections
Training of employees

Job Requirements:

Master or PhD in chemistry, biotechnology, pharmacy or similar subject area
+ 3 years of professional experience in a quality position
Good knowledge of the relevant GMP guidelines, AMWHV and regulations
Experience in quality control including release of raw materials and consumables
Experience with TrackWise Digital or comparable System
General knowledge of biotechnology production and relevant QC responsibilities
Team-oriented and strong quality awareness
Very good German and English skills
German work permit is mandatory
Ready to take responsibility

Our proposal:

A modern work environment with exciting tasks in a future-oriented industry
Teamwork with an intercultural and international team with short communication channels across national borders
A corporate culture characterized by openness and appreciation
Regular company events, capital-building benefits, company pension plan, job ticket, job bike, employer allowances for lunch, a modern time recording system with a flex working hours account and free fruit and drinks

If we have caught your interest and your profile matches the above, we would love to hear from you. We hope to find our new colleague as soon as possible, so please do not hesitate and send your application today. We will review the applicants on an ongoing basis and close this posting as soon as the position is filled.

AGC Biologics GmbH
Czernyring 22
69115 Heidelberg

Vollzeit , Festanstellung

Gruppen- & Teamleitung

Aktualisiert am 13.09.2023

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