FREE ACCESS
5,000–10,000 jobs/day
See all jobs on JobTailor
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Senior Manager, CMC Biologics
ImmaticsSenior Manager in CMC Biologics involved in delivering PRAME immunotherapies in Germany within a hybrid setup. Overseeing CMC documentation and collaborating with various stakeholders to ensure program delivery.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in CMC Development and GMP documentation, with a strong focus on biologics and regulatory submissions. Proficient in technical writing and collaboration with cross-functional teams to ensure compliance and successful program delivery.
Highest-signal resume keywords
CMC DevelopmentGMP DocumentationTechnical WritingRegulatory SubmissionsBiologics Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
CMC DocumentationGMP ComplianceTechnical OperationsProcess DevelopmentAnalyticsManufacturing SciencesBiologics KnowledgeRegulatory RequirementsPhase III SupportPPQ Execution
Soft Skills
Proactive MindsetStructured ApproachEffective Communication
Industry Keywords
Biopharmaceutical IndustryICH GuidelinesGlobal Regulatory ExpectationsQualified PersonsCDMOsCROs
About the role
Key responsibilities & impact- Author, review, and maintain CMC and GMP documentation in accordance with regulatory requirements and industry best practices
- Prepare and review technical and GMP documentation supporting development, manufacturing, technology transfer, validation, and PPQ activities
- Support late-stage GMP manufacturing, commercial readiness, and PPQ execution
- Collaborate with CDMOs, CROs, Qualified Persons (QPs), and internal stakeholders to ensure successful program delivery
- Contribute to CMC content for BLA, NDA, and other global regulatory submissions
- Act as a key scientific subject matter expert (SME), supporting manufacturing investigations, technical issue resolution, and technology transfer activities
- Partner with CMC Biologics, Regulatory Affairs, Quality Assurance, and Project Management teams to ensure milestones, supply continuity, and compliance
- Maintain effective communication with internal and external stakeholders
Requirements
What you’ll need- advanced degree in a natural or life sciences discipline
- 7+ years of relevant experience in the biopharmaceutical industry
- background in CMC Development, Technical Operations, Process Development, Analytics, Manufacturing Sciences, or related functions
- solid knowledge of biologics development, preferably antibodies
- ideally have experience supporting late-stage development programs, including Phase III, PPQ, and regulatory submission activities
- strong understanding of cGMP requirements, ICH guidelines, and global regulatory expectations
- excellent technical writing skills
- highly proactive professional with a structured and solution-oriented mindset
- excellent English skills (at least C1 level)
- preferably proficiency in German
Benefits
Comp & perks- job bike
- job ticket
- Health Programs
- childcare benefits
- relocation allowance
- Company summer and winter events