Senior Process Engineer

Job Title: Senior Process Engineer - Drug Product Development

Location: Hybrid

Employment Type: Contract

Our client, a global biopharmaceutical company, is seeking a Senior Process Engineer Drug Product Development with expertise in CAR-T drug product lifecycle management. Ideal candidates will excel in leading fill-finish process development, container closure system qualification, and stability studies (ICH & in-use) while ensuring compliance with cGMP regulations.

This is an exciting opportunity to join our client who stand out for their dynamic culture that values innovation, collaboration, and a deep commitment to transformative science. Employees thrive in an environment that encourages professional growth, impactful contributions, and the pursuit of groundbreaking advancements.

Key responsibilities:

• Lead fill-finish process development for CAR-T drug products, ensuring scalability, robustness, and compliance with cGMP standards.
• Oversee ICH stability studies, in-use evaluations, container closure system qualification, and E&L risk assessments to ensure product integrity and safety.
• Provide technical leadership for global technology transfers and lifecycle management of drug product manufacturing processes.
• Develop and review essential documentation, including SOPs, risk assessments, and regulatory submissions, supporting commercialization efforts.
• Collaborate with cross-functional teams and contribute to regulatory filings, offering expertise on drug product development and control strategies.

If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact Emily Scott via email on:

If this role isn't suitable for you, please let us know if you can refer anyone - any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Engineering and Manufacturing

Industries

Pharmaceutical Manufacturing and Biotechnology Research

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