We are seeking a CMC Technology Transfer Specialist (m/f/d) to lead the implementation of the drug product manufacturing process and technology at clinical trial locations. In this role, you will be responsible for ensuring that investigational products are successfully introduced and integrated into clinical environments. You will coordinate the preparation of all necessary technical documentation and facilitate knowledge transfer. Your focus will be on enabling the seamless adoption of new processes and technologies at hospitals and other clinical facilities, ensuring compliance with regulatory and quality standards throughout the technology transfer process.
Key Responsibilities:
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Support cross-functional teams to ensure all requirements are fulfilled before transferring processes to clinical trial sites.
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Prepare and maintain documentation, including technology transfer packages, validation plans, risk assessments, and technical reports.
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Oversee clinical site set-up and validation activities, ensuring protocols and reports meet regulatory and quality expectations and project timelines.
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Play a key role in coordinating interactions with third-party CDMOs to support outsourced activities.
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Manage quality-related activities (e.g. deviations, change controls, self-inspections) in line with internal policies and regulatory standards.
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Assist in resolving manufacturing and analytical issues encountered at clinical trial sites.
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Coordinate with internal teams and clinical site partners to align deliverables and timelines.
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MSc or PhD in chemistry, pharmaceutical sciences, biotechnology, or a related field.
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Minimum of five years’ experience in pharmaceutical manufacturing, technology transfer, or CMC development within the biotech or pharmaceutical industry.
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Demonstrated experience in leading technology transfers and supporting GMP manufacturing at clinical or commercial scale.
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Strong understanding of GMP, ICH guidelines, and regulatory expectations for drug product manufacturing.
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Experience working with CMOs or CDMOs, including oversight of external partners and review of technical documentation.
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Excellent communication and coordination skills with the ability to work across functions and manage external relationships.
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Strong attention to detail and documentation skills, with experience supporting regulatory submissions.
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Experience with radiopharmaceuticals, contrast agents, drug-device combinations, or ATMPs, especially in clinical or hospital-based settings, is highly desirable.
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Attractive compensation package, including a competitive base salary and stock options
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Key role in a highly advanced and fast-growing startup company
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Impactful product promoting better understanding and treatment of cancer
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International team, from over 20 different nationalities
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Positive work environment with open communication and a collaborative mindset
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Remote or Hybrid working model possible
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Indefinite employment contract
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30 vacation days
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Flexible working hours
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Annual health budget (Allianz bKV)
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EGYM Wellpass
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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
mail: careers@nvision-imaging.com
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