(Senior) Analytical Expert

Boehringer Ingelheim; Biberach an der Riß; Hybrid; EUR 80.000 - 150.000; Vollzeit

Zusammenfassung

At Boehringer Ingelheim, a growing pharmaceutical company, the Senior Analytical Expert will oversee the development of quality control methods for therapeutic peptides. This role involves leading a team, ensuring product quality, and preparing regulatory documentation in a hybrid workspace. Effective leadership and background in pharmaceutical sciences are essential.

Qualifikationen

• Completed master's degree in chemistry, biochemistry or pharmacy.
• Ideally supplemented by a doctorate in therapeutic peptides.
• Several years of relevant professional experience.

Aufgaben

• Develop/validate quality control methods for parenteral products.
• Lead a team of technical employees.
• Prepare analytical documentation for regulatory approvals.

Kenntnisse

Leadership qualities

Team-oriented

Pressure handling

Ausbildung

Master's degree in Chemistry, Biochemistry or Pharmacy

Doctorate in Therapeutic Peptides

Jobbeschreibung

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 teams
• Fluency 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 development
• Management experience in the line or matrix
  
  
  

Ready to contact us?

If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: [phone] or via mail: [e-mail]

Recruitment process:

Step 1: Step 1: Online application - The job posting is presumably online until July 16th, 2025. We reserve the right to take the posting offline beforehand. Applications up to July 2nd, 2025 are guaranteed to be considered.

Step 2: Virtual meeting end of July

Step 3: On-site interviews end of August

Discover our Biberach site: xplorebiberach.com

Our Company

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths \u2013 and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after \u2013 as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com

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