Pharmaceutical Quality Assurance Specialist
Job details
Alliance Medical RP GmbH , a pharmaceutical company with a team of around 30 employees at its Bonn site and around 20 employees at its Berlin site, manufactures radioactive drugs for nuclear medicine diagnostics using positron emission tomography. As a subsidiary of Alliance Medical GmbH, which is an innovative provider of medical care concepts for hospitals and medical specialists, we combine the advantages of a medium-sized company with the security of a corporate group. To strengthen our international team and working at Spessartstraße 9, 53119 Bonn or at Max-Planck-Straße 4, 12489 Berlin we are looking for a full-time colleague (m/f/d) for the CMC department.
CMC Manager / Pharmacist / Chemist (m/f/d)
Your tasks:
- Support current & new radiopharmaceutical development projects by planning & implementing local CMC activities with a close collaboration in cross-functional teams
- Develop & execute local CMC strategies aligned with business objectives & regulatory requirements from product development to the commercialization phases
- Assisting in the implementation & maintenance of production processes and quality control testing
- Writing & updating GMP documents and ensuring compliance with cGMP
- Reporting the progress to update the contractors or performing on site visits
- Facilitating effective communication and sharing knowledge across departments to support seamless integration of CMC processes
Your Profil:
- University degree in pharmaceutical sciences, chemistry or related scientific discipline.
- Strong understanding of cGMP regulations & regulatory requirements for radiopharmaceuticals.
- At least 2 years of radiopharmaceutical industry experience in production or quality control & quality assurance.
- Experience in technology transfer projects
- Ability to identify and solve complex problems
- Ability to think out of the box and challenge current CMC development strategies
- Being a team player with good communication skills and fluency in English
- Willing to travel in Europe (max. 10%)
- Willing to work in a remote team
Benefits:
- Possibility to work from home
- Position-specific training & development so that we can continue to grow together
- Access to corporate benefits
- 30 days annual leave
- Additional payment towards capital-forming benefits
- Support with e-bike leasing
- Good public transport connections & free company car park
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