Manager Manufacturing Support mAb BioDS (m/w/d)

Daiichi Sankyo Co., Ltd.; Germany (OH); On-site; USD 75,188 - 98,322; Full time

Job summary

Daiichi Sankyo Co., Ltd. sucht einen Manager Manufacturing Support in Pfaffenhofen, um den Aufbau eines neuen GMP-Produktionsbereichs zu leiten. Sie sind verantwortlich für die Entwicklung von GMP-Konzepten und die Erstellung relevanter Dokumentationen.

Ideale Kandidaten haben mindestens 3 Jahre Erfahrung in der biopharmazeutischen Produktion und hervorragende Deutsch- sowie Englischkenntnisse. Die Rolle erfordert eine Hands-on-Mentalität und eine starke Teamfähigkeit.

Qualifications

• Mindestens 3 Jahre Erfahrung in der biopharmazeutischen Herstellung.
• Fundierte Kenntnisse der GMP-Vorgaben (EU-GMP).
• Praktische Erfahrung mit Einwegtechnologien ist von Vorteil.
• Sehr gute Deutsch- und Englischkenntnisse.

Responsibilities

• Aktive Beteiligung am Aufbau eines neuen GMP-Produktionsbereichs.
• Entwicklung und Definition von GMP-Konzepten.
• Erstellung und Implementierung von SOPs und GMP-Dokumentation.
• Enger Austausch mit Projektmanagement und QA.

Skills

GMP Compliance

Coaching

Teamarbeit

Kommunikationsfähigkeit

Problem-solving

Education

Studium in Pharmazie, Biotechnologie oder Biochemie

Job description

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. We are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.

Ab sofort suchen wir für unseren Standort in Pfaffenhofen eine/n engagierte/n.

Manager Manufacturing Support mAb BioDS (m/w/d)

Responsibilities

• Active involvement in building a new GMP production area for biotechnological substances focused on antibodies and single‑use technology during the planning phase.
• Development and definition of GMP concepts (e.g. zone concepts, material and personnel flows, hygiene concepts).
• Creation, review and implementation of SOPs, manufacturing instructions, risk analyses and GMP documentation.
• Close collaboration with project management, QA, engineering and external partners and suppliers.
• Support for commissioning of equipment, facilities and production processes in a GMP environment.
• Participation in qualification and validation activities (e.g. PQ, cleaning and process validation).
• Development and implementation of a training and coaching system.
• Close support / participation in the operational GMP environment with clear presence on the shop floor.
• Creation, maintenance and continuous improvement of manufacturing documents and SOPs.
• Planning and conducting training sessions and direct coaching of employees in the production environment.
• Ensuring GMP‑compliant processes while continuously developing processes and standards.
• Handling deviations including root‑cause analysis and implementation of effective CAPA measures.
• Establishment and steering of change‑control procedures.
• Conducting risk analyses (GMP and EHS).
• Preparation and active accompaniment of inspections and audits.
• Assumption of functions such as hygiene officer for the production area.
• Close collaboration with QA, QC, EHS, development and engineering.

Qualifications

• Completed studies in pharmacy, biotechnology, biochemistry or a comparable field.
• At least 3 years of experience in biopharmaceutical manufacturing, preferably in antibody production and purification (USP/DSP).
• Practical experience with single‑use technologies is an advantage.
• Fundamental knowledge of GMP regulations (EU‑GMP, ideally also international).
• Experience in creating and implementing GMP documentation.
• Basic understanding of manufacturing and purification processes for recombinant proteins.
• Structured, independent and solution‑oriented working style.
• Strong hands‑on mentality and high presence in the production environment.
• Ability to practically coach and support employees.
• Excellent communication and teamwork skills, also in interdisciplinary teams.
• Organizational strength and implementation orientation.
• Very good German and English language skills.