CMC Manager (m/f/d) role at Alliance Medical Radiopharmacy
5 days ago; be among the first 25 applicants
Tasks
- Support current and new radiopharmaceutical development projects at the CMO.
- Assist in implementing and maintaining production processes and quality control testing.
- Perform quality control testing (HPLC, GC, TLC).
- Prepare write, and update GMP documentation.
- Track and report the progress of projects.
- Participate in regular internal project meetings to discuss and plan activities.
- Participate in regular meetings with contract organizations to provide project updates via teleconference or on-site visits, as appropriate.
- Maintain records documenting all relevant communications related to projects.
- Monitor project timelines and contracts for accuracy and follow up on any discrepancies with stakeholders.
- Collaborate closely with other departments within the organization to ensure alignment and effective communication across all project areas.
Profil
- On-site work required.
- University degree in pharmaceutical sciences, chemistry, or a related scientific discipline.
- Knowledge of GMP requirements.
- At least 2 years of experience in quality control (HPLC, GC, TLC) within the pharmaceutical industry.
- Experience in technology transfers and analytical method validation.
- Experience in radiopharmacy will be an advantage.
- Ability to identify and solve critical problems.
- Creative mindset with the ability to think outside the box and challenge current CMC development strategies.
- Strong team player with excellent interpersonal and communication skills.
- Ability to communicate clearly and respectfully at all levels, consistently advocate for your objectives, and drive topics forward with commitment and determination.
- Willingness to travel and work within a remote, international team environment.
- Fluency in English.
Seniority level
Employment type
Industries
- Pharmaceutical Manufacturing
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Location: Warsaw, Mazowieckie, Poland