NL - Associate scientist COVID-19 Vaccine production

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

Would you like to be directly involved in the fight against the global "Corona virus" (COVID-19) pandemic? Then keep reading!

Janssen Vaccines & Prevention B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson and is passionate about the development, production and marketing of vaccines to prevent and combat infectious diseases. The Drug Substance Operations (DSO) department has a GMP manufacturing facility at the Bioscience Park in Leiden where we proudly produce groundbreaking medicines against diseases that have a global impact, such as vaccines against HIV, RSV and Ebola. This is also the place where we will be producing the COVID-19 vaccine material.

To strengthen the department we are looking for an Associate scientist / Senior manufacturing operator, to help us realize the upcoming COVID-19 vaccine manufacturing campaign.

Department:
The department DSO is an international team of about 40 people working on the manufacturing of cell banks, virus seeds and clinical batches (phase I to III) to support the development of new vaccine candidates. Manufacturing activities are performed under strict cGMP regulations and the process is established together with development departments, engineering & maintenance, QC, QA and warehouse. Our passion is to deliver high-quality results to our customers and to seek for opportunities for improvement: never a dull moment!

Within the department four teams operate, each with specific responsibilities: 

• Preparations
• Cell culture
• Downstream processing
• Operations Support Team

The teams are responsible for their cGMP status by maintaining the documentation system, reporting quality issues and performing the resulting corrective actions, master batch documentation, training and inspection readiness. 
 

Job description:

• The associate scientist is primarily responsible for the cGMP production of Clinical Trial Material (CTM), as requested by the organisation.
• The associate scientist holds a senior position and acts as the representative of the Supervisor in his/her absence. As such, you guide, coach and correct other operators to assure they produce the best possible product within the shortest timelines. You feel responsible for the quality delivered by the team and take ownership for improving suboptimal aspects. You will support process excellence activities to continuously improve the work as well as personal skills. Communication with other parties at a level that assures the best possible collaboration and final result is a key requirement.
• Apart from production operations you will be updating documentation, be responsible for predefined process steps, and the state of related equipment. Next to these core tasks small improvements and innovative projects will be a stable part of your daily work package. You will also be tasked to do data management, acute problem solving, and many other small and diverse tasks. As the job entails team work within a diverse and global organisation, we require good communications skills in English. For now, the job requires no shift work and it may require occasional weekend work (planned ahead and compensated according JNJ guidelines). 
   

The candidate...

• has quality always as main goal, efficiency as a second
• aims for full customer satisfaction. What is asked you deliver with the required quality within the agreed timeframe
• has a high degree of accuracy, initiative, and independence
• is flexible and stress-resistant and remains positive when priorities change
• helps team members by giving advice and sharing feedback on technical and personal level
• has great social and trainer skills, is able to provide and receive feedback in a constructive way
• makes himself/herself part of discussions and help transform these into positive actions
• takes ownership for problems you find and are able to bring complex issues to a good conclusion
• shows initiative, you seek out potential solutions yourself
• has operational troubleshooting capabilities
• has a can-do attitude, you can bring projects to their end and can find your own way around obstacles
• is an innovative thinker, able to think up new ideas for old problems

Qualifications and skills:

• Minimum completed HBO (bachelor) degree, preferably in Microbiology/Life Sciences or equivalent pharmaceutical/biotechnology
• 2 years (or more) experience with cGMP manufacturing is a requirement
• Expert in cell culture (USP), virus propagation and / or downstream processing (DSP)
• Experience with change controls, non-conformances and CAPA records
• Experience with cGMP and EHSS standards is required
• Lean green belt certification is preferred
• Able to converse and write effectively in technical English
• Experience as (process) technician or equivalent in life science and for pilot plant operations in a cGMP environment if preferred
   

EXTRA INFORMATION:

• This is a contracting position, with the possibility of an extension after the end date. You will receive a contract via our partner YACHT. They can offer you a contract for the duration of the assignment at J&J, a one year contract or a freelance contract (ZZP).