Pharmaceutical Development and Manufacturing Engineer

We are looking for a pharmaceutical development and manufacturing manager for a temporary position. This person will be responsible for the manufacturing of drug products, improvements of the manufacturing process for orphan oncology drugs in development and join our journey in building and growing the company to improve the lives of patients with rare oncology related diseases.
With direct report to the Vice President Product Development & Supply and IT, you will work in close collaboration with the Contract (Development) Manufacturing Organisation to deliver clinical product and prepare for commercial manufacturing. You will be a key player in a fast-growing cross-functional team and work closely with clinical operations and QA as well as other colleagues across the organization. The position is temporary with a possibility to turn into a permanent position.
Your main tasks
• Deliver robust, scalable and cost-effective manufacturing processes for small molecule drug products
• Review documents and support process improvements and validation activities
• Assist in developing control strategies for our products
• Conducting and coordinating investigations, identifying root cause and implementing 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, and various technical memos as needed
• Work in collaboration with Clinical Operations to secure clinical product supply to clinical studies
Your qualifications
To master this position, you need a track record (minimum three years’ experience) in process development, process validation and manufacturing of pharmaceuticals from either a pharmaceutical company or a Contract (Development) Manufacturing Organisation.
You hold a MSc or BSc from a relevant field of study, for example Chemical engineering, and have:
• Solid knowledge in cGMP
• Experience from pharmaceutical manufacturing processes
• High proficiency 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 colleague and professional you are
• Communicative, curious and ready to learn
• Self-motivated, with the ability to drive tasks, but also know when to involve colleagues
• Structured, with an ability to work effectively in a pharmaceutical start up environment
• Able to see the big picture
• Enthusiastic to operate in a fast-growing cross-functional environment
• Flexible, have integrity, and have an ability to deal with complexity
• Comfortable in working according to our values focus, integrity and courage
• Excited about the Ascelia Pharma’s product portfolio and opportunities ahead
Other information
Travelling: limited travelling will be required.
Work location: Primarily the head office, with the possibility to work from home
Domicile: Hyllie Boulevard, 215 32 Malmö, Sweden
Work permit in Sweden needed
This is a temporary position (one year) with a high probability for the right person to transfer into a permanent position.
How to apply
Please submit your resume and cover letter, via our portal, as soon as possible, but no later than April 24th, 2022. All applications must be in English and are treated confidentially.
Candidates will be assessed as applications are received. Only candidates considered will be contacted.
For more details about the job or the company, please contact VP Carin Linde, +46 735 17 91 14.
What we offer
At Ascelia Pharma, your skills, dedication, and engagement help us improve the lives of people living with cancer. We offer you an opportunity to be part of a fast-growing company with global reach, where engagement, dedication and results are met with opportunities for individual and professional development.
Join us on our journey to improve patients’ lives and build a global orphan oncology life science organization.
Ascelia Pharma currently has two drug candidates – Orviglance and Oncoral – in clinical development. You can read more about them on www.ascelia.com