Senior Process Engineer

Planet Pharma; Leiden; On-site; EUR 60,000 - 100,000; Full time

Job summary

An innovative global biopharmaceutical company is seeking a Senior Process Engineer for Drug Product Development. This role involves leading fill-finish process development for CAR-T products, ensuring compliance with cGMP regulations, and overseeing critical stability studies. The company fosters a dynamic culture that values collaboration and professional growth, offering a unique opportunity to contribute to groundbreaking advancements in the pharmaceutical industry. If you possess strong expertise in drug product lifecycle management and thrive in a fast-paced environment, this position is tailored for you.

Qualifications

• Expertise in CAR-T drug product lifecycle management is essential.
• Experience with cGMP regulations and stability studies is required.

Responsibilities

• Lead fill-finish process development for CAR-T drug products.
• Oversee ICH stability studies and ensure product integrity and safety.
• Provide technical leadership for global technology transfers.

Skills

CAR-T drug product lifecycle management

fill-finish process development

container closure system qualification

stability studies (ICH & in-use)

cGMP compliance

technical leadership

Education

Bachelor's degree in Engineering or related field

Advanced degree preferred

Tools

SOPs development

risk assessment tools

Job description

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: [e-mail]

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

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.