New Product Introduction Manufacturing Process Specialist

Imagine your next role as a New Product Introduction Manufacturing Process Specialist. The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.

roles and responsibilities

Reporting to DSP Lead NPI MPS, this position is responsible for downstream clinical manufacturing phase 1/2a (NPI tech transfer, NPI resupplies) preparation, supporting and troubleshooting, and release.

A New Product Introduction Manufacturing Process Specialist will facilitate an environment of continuous improvement & open communication

The main tasks are:

⦁ Materials planning and ordering

⦁ Change control Assessor and performing implementation activities  

⦁ Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization

⦁ Release of clinical manufacturing batches & documentation

⦁ Represent Operations on cross-functional project implementation teams

⦁ Generate and assist with the generation, review, and revision of Manufacturing documentation as necessary. 

⦁ Lead and Support the investigation and resolution of problems in a pilot plant. 

⦁ Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements.

⦁ Ensure that personal training requirements are completed in compliance with site procedures. Training and support for new recruits to the Manufacturing group

how to succeed

The ideal candidate will be adaptable, and flexible with excellent interpersonal skills.

The candidate will pay attention to detail, will be good at problem-solving, and drive for results and the best performance. 

You will also bring:

• At least a bachelor of applied Science, master's degree or PDEng qualification in either Biochemistry, Pharmacy, Biotechnology, Science or Engineering, Bio-organic chemistry

• Downstream Manufacturing experience within a GMP-regulated environment.

• Experience with purification processes

• At least 3 years experience in Downstream

• At least 3 years experience in AKTA, UFDF, POD, or final fill.  

• Process engineering experience

• Project / New equipment installation experience

• Commissioning and qualification experience

• Experience with Microsoft Word, Excel, and Outlook.

benefits

This role offers a very competitive hourly rate, a hybrid way of working & a supportive working environment. This contract will run initially for one year.

you are welcome here

Janssen is an innovative pharmaceutical company: we work every day on the frontline of health innovation. We can only meet this challenge because of our talented employees. Working at Janssen means that you get every opportunity to optimally develop your career.

about Janssen Biologics

Janssen is the Pharmaceutical Company of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare Company. At Janssen, we bring together top scientists and researchers to pursue the most promising science and drive collaboration to create visionary medicines and healthcare solutions covering five priority therapeutic areas - Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, and Oncology. Contribute to the next pharmaceutical breakthrough with your next project at Janssen. 

https://www.janssen.com/netherlands/nl

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. 

questions

If you would like some additional information about the role please contact:  katerina.alikaridou@randstadsourceright.nl

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”.