Advanced Pharmaceutical Formulation Expert for Small Molecules
3 weeks ago
We are seeking an experienced Senior CMC Specialist to lead small-molecule drug substance projects from candidate selection to commercialization.
Key Responsibilities:- Lead drug substance development for small molecule drug projects from candidate selection to late stage and commercialization
- Drive cross-functional CMC and R&D initiatives, focusing on innovation and excellence in drug substance development
- E nsure regulatory compliance by preparing and reviewing regulatory documentation (IBs, INDs, CTAs, NDAs)
- Manage relationships with high-quality CDMOs to deliver exceptional outcomes
- M.Sc. or PhD in Chemistry, Pharmacy, or related fields
- 10-15 years of experience in small molecules late-stage drug development
- Proven expertise as a Drug Substance Lead, with a strong understanding of ICH guidelines and GMP
- Strong communication and collaboration skills
The estimated annual salary for this role is $140,000 - $160,000, depending on the candidate's qualifications and experience. We also offer a comprehensive benefits package, including health insurance, retirement planning, and opportunities for professional growth and development.
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Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeLundbeck's mission is to restore healthy mental well-being, allowing individuals to reach their full potential.We are seeking a skilled pharmaceutical specialist to join our Pharmaceutical Development team. As an Advanced Formulation Strategist, you will play a crucial role in generating developability assessments and strategies for our pipeline...
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Senior CMC Project Manager
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Research Formulation Specialist
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CMC Regulatory Expert
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Translational DMPK Optimization Expert
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Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeAt H. Lundbeck A/S in Copenhagen, we are currently seeking a Senior Research Scientist to join our Translational DMPK department. This is an exciting opportunity for you to utilize your expertise in guiding the DMPK optimization and characterization of new compounds in our discovery programs.We have a dynamic research organization with close interactions...
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Senior Research Scientist, Translational PK
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