Job Opportunity
The Position
Within our rapidly growing pharmaceutical product area, you will oversee the development of quality control methods and specifications for new products. The focus is on the development of therapeutic peptides in parenteral dosage forms. You will be working in a dynamic environment that opens up new treatment options.
* 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.
* 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 supervise release testing of batches of investigational medicinal products under GMP and support the Head of Quality Control function in ensuring product quality.
* 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.
* 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.
* You will prepare the development analytical documentation for regulatory approvals, answer inquiries from authorities and help prepare documentation for regulatory interactions.
Main Responsibilities
Your main responsibility will be the development of a holistic control strategy for parenteral products of synthetic peptides as Drug & Device Combination Products.
* 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.
* 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
To succeed in this role, you will need:
* A 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 teams.
* Fluency in German and English.
Benefits
We offer a challenging job in a respectful and collegiate global working environment with a variety of innovation-focused approaches and methods. We also place great emphasis on training and development for all employees, because your growth is our growth.
Working Environment
Boehringer Ingelheim is a global employer who advocates for equal opportunities and is proud of its diverse and inclusive culture. We welcome diversity of perspectives and strive for an inclusive environment where our employees, patients and communities benefit.