Country Germany
City Hameln
Functional Area Research & Development
Job Group Formulation Development
Employment Type Permanent Contract
Working time Full-time
At its locations around the world, Siegfried offers employees exciting career opportunities in international settings. We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers. This approach, coupled with our dynamic working environment, make Siegfried an attractive employer.
Your role
• Planung von Personal und Material Ressourcen zur termingerechten Fertigstellung von Bio-Analytischen Entwicklungsprojekten in Abstimmung mit dem Laborleiter Forschung und Entwick-lung.
• Fachliche Führung eines Projektteams in der Bio-Analytischen Entwicklung.
• Erstellung von Qualifizierungsprotokollen und Berichten für bio-analytische Prüfmethoden in Bezug auf Methodenentwicklung, Validierung und Transfer in Englischer Sprache.
• Prüfung und Bewertung der Vollständigkeit von externen Daten zur Durchführung einer Methoden-qualifizierung oder Optimierung, sowie Kostenkalkulation zur Angebotserstellung.
• Erstellung erforderlicher Studienprotokolle und Berichte in Zusammenarbeit mit den Kunden (in englischer Sprache).
• Durchführung von Methodenentwicklungen und Validierungsstudien.
• Überprüfung und Autorisierung von Studienprotokollen, Ergebnissen (Rohdaten) und Berichten.
• Frühzeitige Eskalation aller Probleme und Störungen, die eine Termin und budgetgerechte Bearbei-tung gefährden könnten.
• Interne und externe Kommunikation im Rahmen des Entwicklungsprojektes (Telefonkonferenzen, Kundenbesuche).
• Planung und Durchführung von Versuchsreihen zur Ursachenanalyse und Problembeseitigung bei bio-analytischen Problemen der Routineproduktion.
• Einhaltung der vorgegebenen Termine für Aufgaben und (Teil-)Projekte sowie des Budgets.
• Etablierung von neuem Equipment unter Berücksichtigung von IQ, OQ und PQ samt GMP-gerechter Dokumentation im aktuellen Siegfried Hameln Standard und Erstellung der gerätespezi-fischen Dokumente.
Your profile
• Abgeschlossenes naturwissenschaftliches Studium mit Master Abschluss in Life Sciences, Biologie, Biotechnologie, Pharmazie, wünschenswert PhD in Biotechnologie oder Biologie mit Schwerpunkt auf bioanalytischer Methodenentwicklung.
• Erste Erfahrung im Projektmanagement und der fachlichen Führung eines Teams.
• Min. 3 Jahre Berufserfahrung in der Pharmaindustrie (wünschenswert im GMP Umfeld).
• Teamfähig; selbständige, eigenverantwortliche und verlässliche Arbeitsweise.
• Sehr gute Deutsch und Englisch Kenntnisse.
Working at Siegfried
Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs.
Who we are
In the Midst of People’s Lives – Across the Globe
The Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model.
The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production.
We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products.
What we do in Hameln
Hameln is a renowned contract manufacturer which supplies both national and international pharmaceutical companies. It has over 450 employees who produce sterile medicinal products, mainly for use in hospitals and intensive care facilities.
Main activities
- Contract manufacture of parenteral solutions and suspensions – aseptic or terminally sterilized in ampoules and vials
- Specialist in the production of complex preparations such as anesthetics, flammable and oxygen-sensitive liquids and cold chain products
Special features
- Successful transfers and establishment of new products in sterile production
- Batch size: up to 3500 liters
- Clean room area: 4000 m²
- Batch manufacture and filling of sterile products, from visual inspection through to final packaging
Strategic importance
- Contract manufacturing for parenterals