Experte Forschung und Entwicklung (m/w/d)

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Hamelin, Germany

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Yes

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Job Reference:

e64db97ddc43

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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.

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Prüfung und Bewertung von externen Daten zur Durchführung des analytischen Teils des Technologie Transfers z.B. anhand der Zulassungsdokumente.

Selbstständige Durchführung analytischer Entwicklungsarbeiten wie Methodenentwicklungen, Validierungen, Methodenoptimierungen und Verifizierungen, einschliesslich der Erstellung der entsprechenden GMP-Dokumente in englischer Sprache.

Erstellung von Prüfvorschriften im Rahmen von Neuentwicklungen und Transfers, sowie deren termingerechte Autorisierung.

Durchführung des analytischen Transfers neuer Prüfvorschriften in die Qualitätskontrolle

Durchführung von Formulierungsstudien und Herstellung von Prüfmustern für Formulierungsstudien unter aseptischen Bedingungen.

Planung und Durchführung von Primärpackmittel Dichtigkeitsstudien mittels Helium Leak, sowie druckbasierter physikalischer Messmethoden.

Stabilitätsprüfung im Rahmen von Entwicklungsstudien

Organisation aller Arbeitsmittel, die zur Erfüllung des Arbeitsauftrags benötigt werden, in Abstimmung mit dem jeweiligen Projektleiter Entwicklung

Einhaltung der vorgegebenen Termine für Aufgaben und (Teil-)Projekte sowie zeitnahe Meldung aller Probleme und Störungen an den jeweiligen Projektleiter Entwicklung, die eine termingerechte Bearbeitung gefährden könnten.

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Je nach Aufgabenschwerpunkt, abgeschlossenes Studium im Bereich Life Science, Pharmazie Chemie oder Biotechnologie oder vergleichbare Qualifikation durch Ausbildung, mit mehrjähriger Berufserfahrung in analytischer Entwicklung oder Formulierungs- und Prozessentwicklung parenteraler Darreichungsformen

Mind. 5 Jahre Berufserfahrung (wünschenswert im GMP Umfeld)

Mind. 3 Jahre Erfahrung in der Methodenentwicklung, Schwerpunkt HPLC bzw. Formulierungsentwicklung von Injektionslösungen / Suspensionen (Biologics und Small Molecules)

Gute Deutsch und Englischkenntnisse

Teamfähig; selbständige, eigenverantwortliche und verlässliche Arbeitsweise

Sehr gute Kenntnisse in Microsoft Office, speziell Excel und Word

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 GlobeThe 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

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