Pharmaceutical Development and Manufacturing Engineer

Job description
Do you have a few years of experience from manufacturing in Pharma Industry and GMP and are ready to step in as consultant in a very exciting role as Pharmaceutical Development and Manufacturing Engineer  at our customer Ascelia Pharma? In this role you will be a key player in the development of their pipeline of novel drug candidates within orphan oncology. You will have the opportunity to be one of the driving forces within pharmaceutical development projects, focusing on process development and optimization as well as ensure that the products are prepared for launch.  

Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Responsibilities
Below are some of your responsibilities described in more detail.

• Deliver robust, scalable and cost-effective manufacturing processes for small molecule finished products.
• Review documents and support process validation activities. 
• Assists in developing control strategies for our products.
• Conducting and coordinating investigations into, identifying root cause and implementing effective CAPA’s.
•  Identifying process improvements, developing proposals and implementing changes
• Work with process risk assessments to improve the overall level of process control.
• Ensuring production documentation is aligned with current practice and regulatory and global guidelines.
• Writing/reviewing study proposals, reports, development reports, user requirements, and various technical memos as needed.
• Participate in meetings with contract development and manufacturing organisations.
• Work in collaboration with Clinical Operations to secure clinical product supply to clinical studies.



Qualifications
To be able to succeed and be happy in the role, below qualifications are mandatory:

• MSc or BSc in Chemical Engineering, or other relevant specialization
• A minimum of two years of experience in process development, process validation and manufacturing of pharmaceuticals
• Experience in handling deviations and CAPA’s
• Solid knowledge in cGMP
• Highly proficient in English

If you have experience from secondary packaging, statistical analysis, knowledge within risk management or experience from working at or with a contract manufacturer, it would be to your advantage.

As a person the most useful traits will be that you are communicative, self-motivated and structured, with an ability to be effective in a pharmaceutical start up environment. Further that you are ready and curious to learn and adaptable to changes in work assignments. You have the ability to look at your work from a helicopter perspective and determine when to stand your ground and when to reach out for a sounding board in your colleagues.  

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
Employer: Randstad Life Sciences. The assignment starts as a consultant assignment for 12 months at Ascelia Pharma in Malmö. Randstad applies a 6-month probationary period.

2022-05-22, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information: contact Emma Kronberg, Consultant Manager at Randstad Life Sciences, at emma.kronberg@randstad.se

About the company
Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!