Senior Development Engineer - Welcome to Q-linea

Job description
Q-linea offers you 100+ enthusiastic, motivated and driven co-workers with the ambition to shape the current and future ways of working with infectious disease diagnostics. You will work with experienced colleagues with knowledge from different fields which gives you the opportunity to influence and contribute to Q-lineas continuous development.

As a Senior Chemical Development Engineer, you will be responsible for formulation and process development activities associated with small molecule pharmaceuticals and enzymes/other reagents for intended use in in vitro diagnostic products. You will provide expert advice in planning Q-linea production processes in order to maintain formulation integrity, while achieving production capacity targets. You will act as a mentor and knowledgeable “go-to” colleague within the company, which requires you to actively interact with different groups within the company as well as seek necessary information and actively learn and develop within the field.

The position is initially within the Research department of Q-linea and you will report directly to the Director Research.

Responsibilities
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Manage and lead the development, in-house or outsourced, of high-level, effective, and stable formulations through planning, executing, analyzing and writing experimental reports.

• Coordinate formulation and analytical resources as needed, including resources provided by cross-functional groups.

• Solve complex problems taking a new perspective on existing solutions and explain difficult information in an easy way to build consensus.

• Demonstrate in-depth knowledge in multiple and cross-functional areas and act as an expert in external discussions with suppliers, future partners, and others.

• Ensure that proper document management and control is practiced according to procedures, company QMS and, in relevant cases, ISO 13485 and FDA 21 CFR Part 820.

Other activities but not limited to
• Prepare manufacturing trial documentation for pilot production trials and scale-up operations suitable for the Q-linea’s in vitro diagnostic products. 
• Participate in the set-up and operation of pilot scale equipment and instrumentation for the completion of small production trials in collaboration with the R&D technician. 
• Conduct experimental testing and evaluation of raw materials, dry blends, and bulk product. 
• Develop/review Raw Material and Finished Product Specifications in collaboration with Product Development Manager and Quality Assurance/ Quality Control Dept. 
• Initiate stability testing (accelerated/on-going) of new products and review/report results in collaboration with Product Development Manager and QA/QC Dept. 
• Participate in product failure investigations, for example quality, potency and visual characteristics.

Qualifications
• MSc or PhD in Chemical Engineering, Medicinal Chemistry or other relevant discipline.

• Solid experience of developing processes for formulation of small molecules as well as experience of analytical methods.

• Fluent written and spoken English or Swedish.

Preferred qualification
• Experience in medicinal chemistry development and/or manufacturing 
• Previous work in a leading position (Manager/Project Manager) 
• Life Science business experience 
• IVD product development 
• Good Swedish (understanding, speaking and writing) 

As a person you are approachable and have the ability to communicate clearly and effectively when interacting with the different departments of the company as well as external partners. If you have a positive outlook on life and problem solving comes naturally to you, no matter how big or small a problem is- welcome to Q-linea!

Application
In this recruitment, Q-linea is collaborating with Randstad Life Sciences. For questions regarding this role, please contact recruitment consultant Summer Lovlinger, summer.lovlinger@randstad.se +46 (0) 733154838. Because of GDPR applications cannot be accepted through e-mail so please apply online as soon as possible, and no later than March 3rd 2020 through the following link https://www.randstad.se/arbetssokande/jobb/life-science/

About the company
Q-linea is an innovative research, development and manufacturing company that primarily develops instruments and disposables for rapid and reliable infection diagnostics. Q-linea’s vision is to help save lives by ensuring antibiotics continue to be an effective treatment for future generations. Q-linea develops and delivers preferred solutions for healthcare providers, enabling them to accurately diagnose and treat infectious disease in the shortest possible time.