Employment type: Full-time
Location: Leiden
Are you enthusiastic in developing affordable innovative therapies and participate to the incredible development of Batavia Biosciences? Would you like to contribute in a collaborative team to serving our customers on diverse challenges? We are looking for you, specialist in technology transfer within biopharmaceutical manufacturing!
About Batavia Biosciences
The short version is that Batavia Biosciences (BBS) helps to optimize the route from drug discovery to clinic.
The reality is that we do much more than that: by leveraging the combination of our expert workforce, our broad, international academic and public network and our extensive range of high-end services, we design the optimal route for our customers to reach the one person that we all are 100% committed to: the patient.
The department Clinical Manufacturing is expanding and therefore we are looking for a Technology transfer specialist to strengthen our team.
About the job
The department Clinical Manufacturing is responsible for GMP production of cell banks, virus seeds and drug substance batches suitable for clinical studies. Part of the technology is transferred between Batavia and external organizations and part is transferred between the different Batavia locations. The role is to be connection between sending and receiving sites on technical and organizational level.
As a Technology Transfer specialist you will be representing Batavia in different meetings and translate requirements from different angles into aligned plans for implementation. You will use your technical know-how to assure the best approach is used for Batavia. You will develop standards for executing technology transfer work, to train and align stakeholders involved.
The job requires good cooperation and clear communication with colleagues within different parts of the Batavia organization (such as project management, finance, process development, clinical manufacturing, etc.) as well as with external partners. You are a quick-learner and implement lessons learned for future projects.
You will join an enthusiastic, international team that works in a very collaborative environment. Being part of the department, your personal as well as your professional growth are encouraged and developed.
Responsibilities
- Technology transfer activities
- Responsible for the technology transfer of the processes from Batavia Biosciences to a Manufacturing facility (Upstream, Downstream, Assays) or from another company into Batavia’s manufacturing facility
- Represent BBS at key tech transfer meetings with the CDMOs or external partners.
- Structure the Technology Transfer by using appropriate tools as Gap Analysis, Process Transfer Risk Assessment and/or Technology Transfer plan.
- Manage and execute the operational project activities related to the technology transfer
- Translate the CMO’s or clients’ requirements into Batavia’s documents or processes.
- Process management
- Lead technical meetings and coordinate execution of tech transfer deliverables (such as training, equipment, material and process requirements)
- Develop, implement and continuously improve operational processes and procedures to guarantee a consistent and successful tech transfer
- Stakeholder communication
- Actively promote strategic company objectives and foster company culture
- Refer to your manager in the event of uncertainties or unexpected situations
- Interact and collaborate with other operational departments, project managers and external stakeholders
- Do not disclose any confidential information outside the organization
- Reporting
- Actively report on the progress of technology transfer tasks, evaluations and data analysis.
- Control and report budget allocations for Technology transfer activities. Support project manager in budget construction of activities related to Technology transfer.
Your profile
- Demonstrated project management skills
- Strong interpersonal skills – able to work effectively with different kinds of communities with different norms and communication styles
- Knowledge of technology transfer and GMP pharmaceutical processes is required
- Advanced degree and/or experience in life science.
- Fluency in English and good communication skills
- Quick learner and team player
- At least 2-5 year relevant work experience
You can send your application to Mrs. Ingrid van Aarle, HR Manager recruitment@bataviabiosciences.com
Application by agency or recruiters is not appreciated and will be rejected.
