About Batavia Biomanufacturing
The Fill & Finish SME position is an exciting opportunity to join Batavia Biomanufacturing as a quickly growing team at the Leiden Bioscience Park. Batavia Bioscience and Batavia Biomanufacturing are executing cutting-edge projects for Viral-Therapy and -Vaccines – from feasibility to complete commercial manufacturing – for international clients. With our clients and partners, we deliver projects that improve the everyday lives of people across the globe.
About the job
We are looking for a Fill & Finish SME who enjoys client and other external partner interaction and the technical aspects of the work we deliver to our clients. The ability to inspire confidence from first contact through proposal preparation and project execution is vital as a client-facing SME. As a Subject Matter Expert, you will provide technical leadership on aseptic fill & finish projects locally and worldwide.
Your primary responsibilities will be
Act as a technology leader in the following areas:
- Aseptic Fill & Finish, both highly automated, high-speed line and small-scale semi-automated line, for clinical and commercial purposes.
- Visual Inspection.
- Current in technical and subject knowledge.
- Aware of upcoming technology changes, developments, and innovations.
- Promote knowledge exchange within the company.
- Provide SME support during the building, FAT/SAT, installation, and C&Q activities.
- Set up procedures related to all Fill & Finish activities.
- Participates in building the Fill & Finish organization, inclusive of training and qualification of staff
- Training and mentoring of other Fill & Finish personnel.
- Break problems down to their essence, demonstrate problem-solving skills, and innovate.
- Engage with the network of Subject Matter Experts in the company.
- Support Business Development (BD) as required; this may include supporting client visits, client pitches, proposal writing, and preparation of appropriate supporting materials.
- Prioritize fill & finish prospects in consultation with BD and operations.
- Deploy process SME knowledge and expertise to help develop solutions for clients’ business and project needs.
- Act as an SME in project phases (i.e., planning, feasibility, concept, design & implementation phases).
- Actively support and participate in internal development and innovation activities.
- 5+ years of appropriate experience in pharmaceutical operations.
- Proven knowledge of automated aseptic vial filling, lyophilization and/or other fill finish technologies.
- A good understanding of isolators and RABs and the associated decontamination systems.
- Knowledge and experience in automatic and semi-automatic visual inspection technologies and filled vial closure integrity systems.
- Knowledge and experience in labeling and secondary packaging technologies.
- Familiar with available equipment options and the selection criteria for when such options should be chosen.
- Good understanding of Risk Management and prioritization of mitigating actions.
- Good presentation skills and comfortable interfacing with clients and other external partners, facilitating workshops, and technically assisting project teams.
- Ability to innovate.
- Self-driven, result-oriented, positive outlook and a clear focus on business.
- Comfortable representing Batavia Biomanufacturing and dealing with multi-national clients.
- Ability to work flexibly and travel as necessary for the business and client needs.
- Strong internal and external relationship-building skills.
- Ability to work as a member of a team as well as independently.
- Experience working in local and international business with the added complexity of new markets, extended communications and cultural factors.
You can send your application to Mrs. I. van Aarle, HR Director, firstname.lastname@example.org
No unsolicited assistance from search firms is accepted for this employment opportunity.