Pharmaceutical Development and Manufacturing Specialist, Malmö

Job description
Join Ascelia Pharma for a new role, being 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 to ensure that the products are available for commercial supply. This is, in short, a role with important responsibilities and lots of opportunities for personal development. 

In this role you will get to apply your expertise in cGMP and manufacturing of small molecule pharmaceuticals, and you will be involved in cross-functional collaborations with both internal and external partners. You will report to the Director of Pharmaceutical Development and Manufacturing. To succeed and thrive in this role you should fit well into the Ascelia Pharma values of being a team player with can do-attitude, have a high sense of ownership, lots of curiosity and a problem solving mind set. Welcome to an exciting work place with dedicated people on a mission to improve the lives of people with rare cancers.

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 tech transfer and process validation activities. 
• Assists in developing control strategies for our products.
• Participate in meetings with Contract Development and Manufacturing Organisations.
• Ensures effective, proactive and open communications, horizontally and vertically, in order to achieve transparency and clarity of program goals, progress and issues. 
• Assists in writing pharmaceutical sections of IND/CTA, NDA/MAA.
• Conducting and coordinating investigations into, identifying root cause and implementing effective CAPA’s.
• Pro-actively identifying process improvements, developing proposals and implementing changes.
• Developing and implementing 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.

Working hours
Permanent position, full time.

Qualifications
To be able to succeed and be happy in the role, below qualifications are mandatory:
• MSc in Chemical Engineering, or other relevant specialization
• A minimum of three years of experience in process development, process validation and manufacturing of pharmaceuticals
• Knowledge within Risk Management
• Solid knowledge in cGMP
• Highly proficient in English
• Work permit in Sweden 

It is meritorious if you know Swedish and if you have knowledge and experience within secondary packaging and statistical analysis. 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
Last day for application is 2020-09-29, 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 Emelie Lanner, Recruitment Consultant at Randstad Life Sciences at emelie.lanner@randstad.se or 072-9733382.

About the company
Ascelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates – Mangoral and Oncoral – in clinical development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm