An innovative Biopharmaceutical company, who is focused on the development and production of medicines made to address Central Nervous System disorder-related diseases, is looking for a Synthetic Organic Chemist to help support its Active Pharmaceutical Ingredient development activities and Chemical Manufacturing Processes. The company's pipeline features products in each Phase of Clinical Trials, targeting diseases such as Dementia, Schizophrenia, and Parkinson's. They also successfully produced the first and only product approved for the treatment of hallucinations associated with PDP. They are determined to elevate life through Science and are driven by innovation of their own therapies and solutions.
Responsibilities
- Coordinate and manage Active Pharmaceutical Ingredient (API) development activities
- Effectively manage and oversee Contract Manufacturing Organization drug development activities and Chemical Manufacturing Processes
- Author regulatory documents, technical reports, and batch production records as needed
- Provide on-site support of drug substance scale-up and GMP manufacturing activities
Qualifications
- 5+ years of related experience in a Pharmaceutical or Biotech industry role
- Bachelor's/Master's in Chemistry or Chemical Engineering
- Experience in Process Validation and Quantitative Risk Assessment
- Working knowledge of GMP and ICH guidelines as well as Process Hazards Analysis
- Working knowledge of process scale-up and technology transfer
This is a remote opportunity that begins on a 6-month contract. There is possibility to be extended or converted.
Highly competitive pay + full benefits
If you are interested, please apply today!
