Wissenschaftlicher Mitarbeiter responsible for microbiology projects at MVZ diagnosticum GmbH. Leading teams and organizing workflows within medical laboratory environment in Neukirchen.
DM
Hybrid Principal Scientist/Associate Director, Analytical Development, Clinical Quality Control
Posted 3 months ago
About the role
- Principal Scientist/Associate Director contributing to late-stage analytical development for biopharmaceuticals at Disc Medicine. Overseeing method development and compliance with regulatory standards in a hybrid work environment.
Responsibilities
- Characterize biologic therapeutics using standard analytical extended techniques to explore relationships between structure and function.
- Oversee development of standard protein analysis methods through external vendors and guide transfer analytical methods to separate analytical and QC testing facilities.
- Develop analytical techniques to measure product and process impurities.
- Strengthen relationships with external CDMO partners to establish and manage appropriate scopes of work.
- Provide oversight into external testing facilities for non-GMP and GMP testing.
- Lead method performance investigations, troubleshooting, and laboratory investigations.
- Working and up-to-date knowledge of ICH guidelines and other regulatory guidance.
- Author, review and edit SOPs, protocols, reports, and quality related documentation.
Requirements
- S. degree is required. An advanced degree (M.S./Ph.D.) is preferred.
- 10-12+ years of related experience in the biopharmaceutical industry experience, with 2+ years in late-stage development of antibody or related therapeutics.
- Hands-on experience with multiple analytical methods and specification development; troubleshooting experience with analytical methods using external vendors
- Good knowledge of cGMP and global regulatory requirements.
- Develop relationships and collaborate well with cross-functional groups, including Process Development, Manufacturing, Quality, and Regulatory.
- Self-starter with demonstrated ability to deliver high-quality results in a fast-paced development environment. Ability to effectively prioritize and deliver on tight timelines while remaining flexible in a changing environment.
- Excellent communication and interpersonal skills; ability to convey complex ideas succinctly.
- Experience in IND and BLA filings is highly desired.
- Ability to travel occasionally
Benefits
- Comprehensive benefits
- Competitive compensation packages
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