GMP Material Scientist

Are you driven by challenges and seek to harmonise scientific knowledge with regulatory compliance? Do you aspire to navigate a complex work environment, with numerous stakeholders involved? If it sounds like you, we are looking forward to welcoming you in the Raw-Reg team within Material Manufacturing Development (Material ManDev). Submit your application today! The position As GMP Material Scientist, you play a key role in contributing to [xxxxx]’s Marketing Authorisation Applications by writing external specifications for raw materials, excipients, and purchased APIs in collaboration with various internal stakeholders. As part of our team, you are also involved in change requests, deviation handling, and optimisation projects. This will give you a variety of challenges, and therefore strong collaboration with your colleagues is essential. Your primary responsibilities encompass:

Writing, reviewing, and updating regulatory documentation related to raw materials

Participating in filing projects

Issuing statements and Certificate of Analysis for GMP raw materials

Evaluating of GMP raw materials of animal origin

Supporting stakeholders regarding regulatory matters related to GMP raw materials

Physical attendance in the office is a must (as a minimum twice per week). Moreover, it is essential that you are a sociable person, that is interested in bonding with your colleagues and proactively contributes to a good atmosphere at the office. You will be part of a team where ideas, problems, and solutions are discussed in an open and positive and forthcoming atmosphere. The position is currently based in Bagsværd but we are relocating to Taastrup around December 2024. Qualifications To be successful in this role, we imagine you:

Hold a Master´s Degree in Chemistry, Pharmacy, Engineering, or another relevant discipline

Demonstrate familiarity with GMP, ICH guideline, and pharmacopoeia requirements

Possess a high GMP, compliance, and quality mind-set, coupled with a flair for IT systems

Display proficiency in both written and spoken English

Additionally, it would be an advantage if you also have knowledge within digitalisation and a good eye for processes and optimisation. On a personal level, it is of paramount importance that you are an excellent team player, but at the same time, that you are not afraid to speak up and challenge your peers in a constructive and meaningful way. About the department
You will join our Raw-Reg team within the Material ManDev department. We consist of ~50 employees organised in four teams, with this position situated in the Excipient Team. We are responsible for the development, implementation, and management of complex materials (raw materials, excipients, primary packaging materials etc.) from use in development to production, and we maintain documentation on existing materials. Working at [xxxxx] At [xxxxx], we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact
For further information you can contact Associate Manager, Maria Diamantidou, at +[xxxxx]. Deadline
29 May 2024. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.