Analytical Development / QC Consultant Pharma

Project overview

For our pharmaceutical customer, we are currently looking for a freelancer for the area of Analytical Development / Quality Control.

The consultant will play a central role in managing the product-level analytical control system and coordinating the analytical strategy throughout the entire product lifecycle. They will act as an interface between the relevant stakeholders, including the Innovation Unit, local QC units, Development Operations, and external partners such as CMOs and CLOs.

Support in the further development of the product-level analytical control system within the scope of defined project orders. Development and coordination of proposals for the analytical strategy for defined project phases. Support for technical coordination between the parties involved in the project.

Framework Data

Responsibilities

Must-haves

• Support in the further development of product-level analytical control systems within the scope of defined project orders
• Development and coordination of analytical strategies for different project phases
• Technical collaboration with project stakeholders from development, QC, and other relevant areas
• Development of concepts and recommendations for analytical issues and solution approaches
• Preparation and technical support of QC activities
• Support in analytical transfer projects, considering regulatory requirements
• Creation of GMP-relevant documentation and contributions to registration documents
• Processing of complex analytical issues within defined project scopes
• Several years of experience in the analytical environment of the pharmaceutical industry
• Sound knowledge in the field of Analytical Development and/or Quality Control
• Experience with GMP-regulated processes and documentation
• Know-how in the field of analytical methods and transfer projects
• Experience in collaboration with different specialist areas within pharmaceutical development projects
• Very good German and English skills

Nice to have

Interested? Please send me your current profile including your hourly rate expectation by email.

If this request does not perfectly match your profile, I would also be pleased to receive your feedback. We are happy to discuss other exciting projects that better suit your expertise and expectations. I look forward to your message!

Feel free to share this offer with your network.

• Experience with biological active ingredients, new modalities, or complex development projects
• Knowledge of regulatory requirements in the international pharmaceutical environment
• Experience in the creation of registration documentation
• Know-how in the strategic further development of analytical concepts

Project details

asap

Utilization: 200%

approx. 12 months

Mainz area and remote

• Start: ab sofort
• Duration: 12 Monate
• Remote: hybrid
• Location: Mainz, Deutschland, DE
• Languages: German