Life Cycle Management Scientist (Pharmaceutical, Kvistgaard)

Job summary

The Life Cycle Management (LCM) Scientist plays a vital role in overseeing the post-approval lifecycle of vaccine products, ensuring robust manufacturing processes and regulatory compliance. This position involves collaboration with various teams to drive lifecycle strategies that enhance operational excellence in vaccine production.

Qualifications

• Advanced degree (MSc, PhD) in Pharmacy, Chemistry, Biochemistry, or a related discipline.
• Minimum of 3 years of experience in pharmaceutical development or manufacturing, with a preference for biologics or sterile products.
• Strong stakeholder management and communication skills.
• Proficient in project management and problem-solving.
• Fluent in spoken and written English.

Responsibilities

• Coordinate lifecycle activities to optimize processes in formulation, filling, and assembly for commercial products.
• Maintain and update lifecycle documentation, including Product Quality Reviews (PQR), risk assessments, and control strategies.
• Act as the technical point of contact for Contract Manufacturing Organizations (CMOs) involved in drug product manufacturing.
• Provide scientific and technical support for aseptic filling processes, including formulation handling and filling into primary containers.

Skills

• Excellent communication and interpersonal skills.
• Strong organizational abilities and capacity to work independently and collaboratively.
• Adaptability to change with a positive and solution-oriented mindset.

Education

• Advanced degree in a relevant scientific field.

Tools

• Familiarity with lifecycle documentation and regulatory compliance processes.