Johnson & Johnson
Technical Transfer Specialist
Secondary Technical Transfer Specialist
Location: Belgium (must reside and have eligibility to work in Belgium)
Hours: 40 hours, remote role, contract assignment until 31st Dec (possible extension)
Essential: Previous experience of packaging materials, manufacturing, production, pharmaceutical, technology transfer,
The Role:
The Secondary Technical Transfer Specialist team are responsible for supporting the technology transfer to new J&J locations and or CMO partners. The Secondary Technical Transfer specialist will represent MSAT and collaborate closely with partners to guarantee smooth and efficient tech transfer.
We are looking for a dedicated Secondary Technical Transfer Specialist to join our team. This role requires an individual who is detail-oriented and possesses strong knowledge of primary packaging materials, DP filling lines and analytical and project management skills.
The specialist will be mainly responsible for change controls related to secondary technical transfer programs, ensuring compliance and quality in our packaging materials. In addition, the specialist will be also working on the definition and creation of a strategy to assess the compliance of primary packaging materials to Japanese and Chinese Pharmacopeia”.
Key Responsibilities:
Change Control Management: Lead and manage all change controls associated with secondary technical transfer (e.g. Tec/Tal at Patheon and Schaffhausen, Darzalex IV at Lonza, etc), preparing all related deliverables.
Specification Review: Review and evaluate specifications from Contract Development and Manufacturing Organizations (CDMOs) to ensure alignment with JJIM quality standards.
Comparability Reporting: Write comprehensive comparability reports for primary packaging materials to assess processability.
Regulatory Support: Provide support in preparing and submitting regulatory documentation to assess quality and regulatory compliance (e.g. Nitrosammine statement, 3.2.P.7 Container Closure System, etc.)
Compliance Assessment: Lead change control initiatives to assess adherence to Japan Pharmacopeia (JP) and Chinese Pharmacopeia (ChP) Pharmacopeia for primary packaging materials.
Profile
Minimum of 5 years experience working within Technology Transfer.
Thorough knowledge of primary packaging
Project management experience from both technical and deliverables perspectives
Fluent in English
5 years plus experience
Previously worked within a pharmaceutical environment
Benefits
This role offers a competitive hourly rate & a supportive working environment.
About Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.
For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.
https://www.jnj.com/healthcare-products/medtech
application process
We are looking to process the first round of applications within the next 2 working days.
We do not accept applications via email. Please apply via the link.
Diversity, Equity & Inclusion
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.