Fill-Finish Process Specialist at Janssen Vaccines
The individual operates at the technical interface between Janssen Vaccines & Prevention Leiden (JVL) and the (external) DP manufacturing sites. The main purpose of the individual is to set up the plans for process development, process characterization and process validation activities and ensure this is done in according to the project specific timelines and in compliance with applicable quality and regulatory standards. The related responsibilities focus mainly on late stage process development activities and process performance qualification until planning for Continued Process Verification as part of Life Cycle Process Validation.
- Accountable for the setup, reporting and timely execution of (outsourced) process development, characterization and validation activities
- Responsible for establishing and maintaining a trustful and professional relationship with the external partner (if applicable)
- Responsible to ensuring close collaboration with the FFP manufacturing specialist and ensuring alignment with project needs through Technical Integrator
- Responsible as technical subject matter expert in case product or process specific assessments are required
- In case studies are outsourced, responsible for review of the documentation prepared by the external partner that is required for process development, characterization and validation
- Responsible for timely informing/escalating issues as needed
- Responsible to provide input and review the required documentation which will be included in the filings
Key Performance Indicators:
- Delivery of assigned project deliverables in full as planned, most importantly pre-clinical and clinical batches
- Pro-active identification of issues, problem-solving capabilities, and timely implementation of solutions at external partner
- Trust and professionalism within the team and in relationship with external partner
- Communication skills, including conflict prevention/handling
- Flexibility to help within the development and manufacturing team based on work load
Specific professional/technical requirements
Education: MSc/BSc in relevant discipline, like pharmaceutical sciences, pharmacy, (bio)chemistry or other life sciences or engineering.
Languages: English (required), Dutch (plus)
Specific Knowledge: In-depth understanding of Life Cycle Process Validation (including late stage process development, process characterization, process performance qualification and continued process verification) and GMP manufacturing of vaccines and/or large molecules.
Experience: At least 10 years of experience in vaccine and/or large molecule process development and GMP drug product manufacturing. Experience with the following is a strong advantage: technology transfers, GMP manufacturing and outsourcing.
Other: Independent on location, flexible, collaborative, communicative and motivating, enjoys working in a team. Is able to travel frequently (10%) and stay abroad for up to 1 week. Interpersonal skills and business acumen are key for this position.