Drug Product Lead Parenteral Iron

CSL Behring Vifor seeks a Senior Drug Product Lead for parenteral iron products within its EMEA region. This hybrid role focuses on CMC development, technology transfer, and manufacturing oversight.

This position sits within the Integrated Product Team for Iron & Small Molecules under Technical Operations. The primary objective is to lead technical efforts related to iron-based parenteral therapies, ensuring robust development and manufacturing processes.

Responsibilities

• Define strategies, deliverables, and risk assessments for CMC development, technology transfer, and continuous improvement work packages.
• Develop and review project execution plans, including technical transfer strategies.
• Act as the subject matter expert for aseptic and terminally sterilized parenteral manufacturing, executing relevant project tasks.
• Serve as the main technical liaison for external contract manufacturing organizations (CMOs) and internal stakeholders.
• Conduct change control impact assessments and support investigations into quality events.
• Evaluate cost-effective sourcing options and participate in technical due diligence visits at prospective CMOs.
• Travel to CMO sites to oversee technical implementation and resolve manufacturing issues.
• Provide technical documentation and advice to decision-making bodies and negotiation teams.
• Compile and review necessary technical documentation for regulatory and operational purposes.
• Collaborate with CMOs to enhance quality, compliance, and cost efficiency, contributing to business case development.

Requirements

• Bachelor’s or Master’s degree in natural sciences, life sciences, or engineering (e.g., Biology, Chemistry, Pharmaceutics).
• At least five years of experience in the pharmaceutical industry, with direct involvement in full-scale commercial manufacturing of intravenous parenteral products.
• Deep expertise in sterile and aseptic fill-finish CMC development, equipment/process qualification, validation, and manufacturing.
• High flexibility and a willingness to travel, with prior experience in external manufacturing environments.

Nice to have

• Familiarity with GMP requirements and guidelines for CMC lifecycle management, including Annex 1.
• Experience working with non-transparent solutions.
• Knowledge of various primary packaging solutions for parenterals, such as vials, ampoules, and infusion bags.
• Experience in other drug product and finished product manufacturing and technology transfer, such as oral solid dosage forms.
• German language skills are considered an advantage.

What the company offers

• Access to information regarding CSL benefits and well-being support via a dedicated resource link.

About the company

CSL Vifor operates as a global partner in pharmaceuticals and innovative therapies, specializing in iron deficiency and nephrology. The company focuses on strategic global partnering, in-licensing, and the development, manufacturing, and marketing of products for precision healthcare. Inclusion and belonging are central to CSL’s mission, fostering a culture rooted in curiosity and empathy.

• Global partnership in innovative therapies for iron deficiency and nephrology.
• Focus on strategic partnering, in-licensing, and precision healthcare products.
• Commitment to inclusion, belonging, curiosity, and empathy.

How to apply

Documents to submit:

• Online application

Application language: English