Germany onlyAs a CMC Process Development Specialist (m/f/d), you will play a crucial role in developing and validating manufacturing processes and reagent kits. Your focus will be on ensuring these processes are robust, scalable, and compliant with regulatory requirements. You will work closely with cross-functional teams and oversee partnerships with Contract Development & Manufacturing Organisations (CDMOs) to optimise workflows, facilitate technology transfer, and maintain high-quality standards. Additionally, you will prepare and review CMC documentation to support regulatory submissions.
Key Responsibilities:
CDMO & Process Development:
Manage the scale-up and optimisation of manufacturing workflows to meet clinical and regulatory requirements.
Oversee and coordinate CDMO partnerships, ensuring efficient development, validation, and technology transfer of manufacturing processes.
Evaluate and monitor third-party performance to maintain compliance with regulatory and quality standards.
Collaboration & Technical Support:
Work cross-functionally with R&D, product development, and quality assurance teams to enhance process efficiency and ensure regulatory compliance.
Provide technical expertise in process development, impurity analysis, toxicology studies and quality control.
Support troubleshooting and resolution of manufacturing and analytical challenges.
Documentation & Compliance:
Prepare, review, and maintain CMC-related documents, including reports, protocols, SOPs, and eCTD modules.
Ensure accurate and complete documentation of process development activities for regulatory submissions.
Adhere to GMP, GLP, and ICH guidelines while ensuring data integrity and compliance with global regulatory standards.
MSc or PhD in pharmaceutical sciences, chemical engineering, or a related field.
At least three years of experience in process development, manufacturing, or a related role within the pharmaceutical or biotech industry.
Demonstrated expertise in CMC development, technology transfer, and manufacturing process validation.
Strong scientific skills, with a passion for experimental work in innovative drug development.
Experience managing CDMO partnerships and working with external manufacturing partners.
A strong understanding of GMP, GLP, ICH guidelines, and regulatory requirements for pharmaceutical product development.
Excellent problem-solving skills and the ability to collaborate effectively within a cross-functional team in a dynamic environment.
Strong technical writing skills, with experience preparing CMC documentation and regulatory submissions.
Experience in contrast agents, radiopharmaceuticals, or drug-device combinations is advantageous.
Attractive compensation package, including a competitive base salary and stock options
Impactful product promoting better understanding and treatment of cancer
International team, from over 20 different nationalities
Positive work environment with open communication and a collaborative mindset
Remote or Hybrid working model possible
Indefinite employment contract
30 vacation days
Flexible working hours
Annual health budget (Allianz bKV)
EGYM Wellpass
Relocation support
Join us in making a difference! Submit your application to be considered for this exciting opportunity.
Any questions? Please contact:
Emilija Stojanovska
Sr. Talent Acquisition Manager
