Senior) Analytical Expert
Vor 3 Tagen
**The Position**
Within the Analytical Development New Chemical Entities department at the Biberach site, you will oversee the development of quality control methods and specifications for new pharmaceutical products. The focus is on the development of therapeutic peptides in parenteral dosage forms. You will be working in a rapidly growing pharmaceutical product area that opens up new treatment options.
This position can be performed in a hybrid work mode with at least 3 days per week on-site.
**Tasks & responsibilities**
- In your new role you will be responsible for the development/validation of specifications and quality control methods for parenteral products of synthetic peptides as Drug & Device Combination Products.
- As a technical manager, you will lead a team of technical employees and actively support them in the implementation of the above-mentioned main tasks.
- In addition, you will plan and monitor stability tests under GMP and derive the shelf-life for clinical and market products based on the data obtained.
- You will also supervise release testing of batches of investigational medicinal products under GMP and support the Head of Quality Control function in ensuring product quality.
- Moreover, you will coordinate the transfer of drug product analytical methods to internal and external quality control units and work closely with international colleagues from process development, production and quality control.
- In interdisciplinary CMC teams, you will actively contribute to product development and plan the necessary work packages together with Pharmaceutical Development until the product is ready for the market.Furthermore, you will prepare the development analytical documentation for regulatory approvals, answer inquiries from authorities and help prepare documentation for regulatory interactions.
**Additional tasks for Senior Analytical Expert**
- Your main task/responsibility will be the development of a holistic control strategy for parenteral products of synthetic peptides as Drug & Device Combination Products.
- As a Senior Analytical Expert you will represent the discipline of product analytics in interdisciplinary development teams and plan the necessary work packages in close cooperation within the teams until the products are ready for the market.Additionally, you will also be responsible for the preparation of internal guidance documents for parenteral development, peptide development or the development of Drug & Device Combination Products.
**Requirements**:
- Completed master's degree in chemistry, biochemistry or pharmacy, ideally supplemented by a doctorate in the field of therapeutic peptides and several years of relevant professional experience
- Expertise in manufacturing, control and/or regulatory requirements for therapeutic peptides
- Knowledge in the field of pharmaceutical product development
- Leadership qualities as well as the ability to work under pressure, a confident manner and a team-oriented way of working in interdisciplinary project teamsFluency in German and English
**Additional requirements for Senior Analytical Expert**
- Several years of relevant professional experience in an international context
- Strong expertise in manufacturing, control and/or regulatory requirements for therapeutic peptides
- Good knowledge of pharmaceutical product developmentManagement experience in the line or matrix
**Ready to contact us?**
Recruitment process:
Step 2: Virtual meeting end of July
Step 3: On-site interviews end of August
-
Post Doc
vor 15 Stunden
Biberach an der Riß, Deutschland BI Pharma GmbH&Co.KG Vollzeit**The Position**: We are seeking you as a highly motivated and innovative Postdoctoral Scientist to join our Analytical Development Biologicals department located in Biberach, Germany. Drive projects related to establishing a novel long-acting dosage form for biological molecules. Your contributions and expertise will benefit patients with a currently unmet...
-
(Senior) Analytical Engineer
vor 3 Wochen
Brandenburg an der Havel, Deutschland ENERTRAG SE Vollzeit100 Prozent fossilfrei: Daran arbeiten wir seit 25 Jahren und treiben Projekte voran, die andere für undenkbar halten.Scrollen Sie nach unten, um die vollständigen Einzelheiten des Stellenangebots zu erfahren, einschließlich der erforderlichen Erfahrung und der damit verbundenen Pflichten und Aufgaben.Mit Wind, Sonne und grünem Wasserstoff erzeugen,...
-
Senior Experte Controlling M-w-d
vor 16 Stunden
Giengen an der Brenz, Deutschland Albert Ziegler GmbH Vollzeit**Senior Experte Controlling m-w-d in Giengen an der Brenz***: 24181 Als zukunftsorientierte Firmengruppe setzt die ZIEGLER Gruppe auf langfristiges Wirtschaften, basierend auf Leistungsfähigkeit, Zuverlässigkeit und Nachhaltigkeit. ZIEGLER produziert Feuerwehrfahrzeuge und feuerwehrtechnisches Zubehör seit 1891. Ergänzt wird dies durch unser...
-
Senior) Site Master Planner
vor 2 Wochen
Biberach an der Riß, Deutschland BI Corporate Center GmbH Vollzeit**The Position** Join our small, international team of experts in a unique in-house masterplanning role, driving the development of strategic site masterplan frameworks for Boehringer Ingelheim’s national and international sites. As a Senior Manager, you will shape the global SMP strategy, influence long-term site development, represent the function in...
-
Post Doc
vor 1 Woche
Biberach an der Riß, Deutschland BI Pharma GmbH&Co.KG Vollzeit**The Position**: We are seeking an enthusiastic, highly motivated and creative postdoctoral scientist to join our Analytical Development department. Within our interdisciplinary team including pharmaceutical and analytical development, we develop innovative new dissolution methods to face current and future challenges. The Post-Doc position will involve...
-
Junior) Head of Laboratory
vor 1 Woche
Biberach an der Riß, Deutschland BI Pharma GmbH&Co.KG Vollzeit**The Position** We are looking for a Laboratory Head with an excellent background in the field of organic and inorganic trace analysis. Join our international team of experienced scientists and develop advanced analytical methods with your team for our innovative products within our Analytical Development department for new chemical entities in Biberach....
-
Senior) Clinical Program Lead Eye Health
vor 15 Stunden
Biberach an der Riß, Deutschland BI International GmbH Vollzeit**The Position**: In your new role, you are responsible for the design and preparation of late clinical development plans in the TA Eye Health (EH), and submission documents to prepare assets in one or more of the following areas: Retinal health including intermediate to late AMD, Geographic Atrophy (GA) and Diabetic retinopathy (DR), DME and inherited...
-
Head of Computational Biology
vor 1 Woche
Biberach an der Riß, Deutschland BI Pharma GmbH&Co.KG Vollzeit**The Position** This position has a hybrid setup with approximately 2-3 days per week on site. **Tasks & responsibilities** - In your new role, you will drive innovation as the primary computational partner for the Neuroscience & Mental Health Therapeutic Area, collaborating with leaders across Discovery Research, Translational Medicine, and Clinical...
-
Senior Expert Valves
vor 2 Wochen
Heidenheim an der Brenz, Deutschland Voith Group Vollzeit**Über die Voith Group** Die Voith Group ist ein weltweit agierender Technologiekonzern. Mit seinem breiten Portfolio aus Anlagen, Produkten, Serviceleistungen und digitalen Anwendungen setzt Voith Maßstäbe in den Märkten Energie, Papier, Rohstoffe und Transport & Automotive. Gegründet 1867 ist Voith heute mit rund 22.000 Mitarbeiterinnen und...
-
Junior/senior Non-key Experts
vor 2 Wochen
Bad Homburg vor der Höhe, Deutschland GOPA Worldwide Consultants GmbH Vollzeit**Country**: - Serbia **Position**: - Junior/Senior Non-Key Experts **Department**: - Governance and Economic Development **Status**: - Implementation **Published**: - 18/02/2025 **Deadline**: - 02/03/2025 **Name of project**: - EU for Public Administration Reform - Complementary Assistance to Sector Performance Reform Contract for Public...
