Senior QA Specialist/ Scientist to CDMO

Are you passionate about ensuring compliance with industry standards? Do you want to be part of a rapidly growing integrated CRO and CDMO facility - making groundbreaking discoveries in oncology and cardiovascular diseases? Join us as we work together to drive innovation and science to deliver impactful solutions for our collaborators!
Minerva Imaging is at the forefront of R&D in the theragnostic area, and we are in a very fast paced environment, where our cooperation directly impacts the advancement of new improved and lifesaving drugs for seriously ill cancer patients. We have the ambition to be the difference for our clients, collaborating on advancing new treatment modalities to patients. To continue our growth, we are looking for a new senior QA Specialist/ Scientist to join our CDMO facility with the focus of ensuring compliance with industry standards and contributing to the development of radiopharmaceuticals for patients with an unmet medical need.

The job
In this role, you will play a key part in ensuring the highest standards of quality within our operations. Your responsibilities will include providing expert input to drive updates of Minerva Imaging’s Quality Management System (QMS) and overseeing daily operational activities to ensure compliance with both company and industry standards. You should excel in the following tasks, bringing a proactive approach and a passion for delivering high-quality results in each area:

• Provide proficient quality input and drive updates of Minerva Imaging’s QMS and operational activities
• Secure documentation, procedures and processes are maintained in compliance with company and industry standards
• Author, review and approve procedures, deviations, CAPAs, risk assessments and change controls
• Organize and maintain the cleanrooms (grade C/D/CNC) and isolators (RABS) in a validated state
• Provide/facilitate QA know-how, support and training to the organization

Qualifications
To be successful in this role, you should have good problem-solving skills, be results-driven with a positive, can-do attitude, and work effectively as part of a team. You should bring a solid academic background and relevant experience within the pharmaceutical industry. The ideal candidate will have the following qualifications:

• You hold a MSc degree or equivalent in pharmacy or in a relevant life science subject
• You have a very good knowledge of GMP guidelines and regulations, sterile products is an advantage
• At least 5 years of experience from the pharmaceutical industry or radiopharmacy is an advantage
• Quality mindset and attention-to-detail approach to your work
• Ability to drive projects in teams collaboration and on your own

Minerva offers:
Minerva Imaging offers a combined compensation package with a base salary, pension and a company wide bonus program. We believe in creating an agile working environment, so we have flexible working options including the option of working from home. We care about our employees’ well-being and offer health insurance and a quality conscious lunch scheme and monthly social activities.

We are an informal organization with a strong focus on open and honest communication. We value humour and a natural care for one another.

Application:
Please submit your application to us no later than 15th. of December The application must include a motivated cover letter and a CV addressing the listed qualifications. Applications will be evaluated continuously and we will hire when the right candidate has been found, hence do not hesitate to apply for the job today.

If you have questions regarding the position, please contact Johan Hygum Dam at [email protected]

About Minerva Imaging:
Minerva Imaging is a scientifically driven and integrated CRO and CDMO specialized in targeted radionuclide therapies. We focus on the use of advanced animal models within oncology, cardiovascular diseases, and in vivo molecular imaging for translational research and drug development.

We engage with our sponsors to understand their scientific questions and discuss how our methods and capabilities can provide answers. Our facility located in Ølstykke, Denmark offers best–in–industry fully integrated radiopharmaceutical research, drug development, and manufacturing services.

Minerva Imaging is an equal opportunity employer, and we encourage candidates of all backgrounds and experiences to apply.

Follow us on LinkedIn for the latest news updates or visit www.minervaimaging.com for more information.

Department: QA

Deadline: 15 December 2024

Location: 3650, Ølstykke, Denmark