Remote Senior Process Chemist – Drug Substance

Openkrill; United States; À distance; USD 165 000 - 185 000; Plein temps

Avantages offerts par ce poste

Health insurance

Dental & Vision

Life insurance

AD&D

Discretionary bonus

401(k) match

Stock options

PTO & holidays

Résumé du poste

Praxis Precision Medicines is seeking a Principal Scientist in Process Chemistry to lead drug substance activities for multiple projects, guiding design, development and scale-up from lab to pilot plant in a fast-paced, Agile environment.

The role requires 5+ years in CMC for small molecules, expertise in GMP, CRO/CMO partnerships, and data packages for regulatory submissions, with remote work and travel as needed. Excellent collaboration and leadership are essential.

Qualifications

• Advanced degree or commensurate experience in Organic Chemistry, Pharmaceutical Sciences, Engineering, or related discipline.
• Minimum of 5+ years of industry experience in CMC specifically for small molecule drug substance.
• Experience with third-party CRO/CMO partners and associated service providers.
• Strong knowledge of US and EU cGMP requirements and best practices relating to drug substances and drug products.
• Experience with salt/crystalline form selection; oligonucleotide chemistry is a plus.

Responsabilités

• Leads the Process Chemistry Research and Development for one or more projects from early to late phase within Praxis.
• Designs both early phase and late-phase/commercial drug substance process and leads their demonstration from lab to pilot plant.
• Provides chemistry and technical leadership throughout the lifecycle.
• Participates/leads activities to identify final API forms for pharmaceutical development.
• Works closely with formulations, analytical, operations, engineering and quality to deliver clinical and commercial drug substance.
• Identifies and leads external CRO/CDMO organizations to achieve deliverables.
• Analyzes external data to drive synthetic experimental plans at CROs and CDMOs.
• Authors or co-authors regulatory submissions.
• Defines manufacturing strategy and GMP requirements and issue resolution.
• Assesses new trends in process development, quality and manufacturing for Praxis products.
• Manages quarterly budgeting of drug substance activities.
• Contributes to inventions that strengthen Praxis IP.

Connaissances

Process Chemistry Leadership

Continuous processing

CRO/CMO collaboration

Agile environment

Interpersonal communication

Formation

Advanced degree in Organic Chemistry or related field

Description du poste

Praxis Precision Medicines is seeking a Principal Scientist in Process Chemistry to lead drug substance activities for multiple projects, guiding design, development and scale-up from lab to pilot plant in a fast-paced, Agile environment.

The role requires 5+ years in CMC for small molecules, expertise in GMP, CRO/CMO partnerships, and data packages for regulatory submissions, with remote work and travel as needed. Excellent collaboration and leadership are essential.