Senior Process Chemistry Lead — Small Molecules (Remote)

Praxis Precision Medicines; United States; Remote; USD 165,000 - 185,000; Full time

Benefits offered by this job

401(k) matching program

Stock-based incentives

Discretionary quarterly bonus

Flexible wellness benefit

Generous PTO and holidays

Job summary

Praxis Precision Medicines is seeking a Principal Scientist in Process Chemistry in the United States. You will lead drug substance activities, designing processes from lab to pilot plant and maturing them to commercial supply for clinical and regulatory milestones.

You will collaborate across CMC teams, engage with CRO/CMO partners, and contribute to regulatory submissions while ensuring quality and supply for Praxis programs with an entrepreneurial, agile mindset.

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 to develop and manufacture pharmaceutical products.
• Knowledge of US and EU cGMP requirements and CMC development across all phases of drug development.

Responsibilities

• Lead Process Chemistry R&D for projects from early to late phase.
• Design and demonstrate drug substance processes from lab to pilot plant.
• Provide chemistry leadership throughout lifecycle and collaborate with CMC teams.
• Identify final API forms for pharmaceutical development and select process routes.
• Coordinate with CRO/CDMO partners to deliver clinical and commercial supply.

Skills

Process Chemistry

Leadership

cGMP knowledge

External collaboration

Oligonucleotide chemistry (plus)

Education

Advanced degree in Organic Chemistry/Pharmaceutical Sciences/Engineering

Job description

Praxis Precision Medicines is seeking a Principal Scientist in Process Chemistry in the United States. You will lead drug substance activities, designing processes from lab to pilot plant and maturing them to commercial supply for clinical and regulatory milestones.

You will collaborate across CMC teams, engage with CRO/CMO partners, and contribute to regulatory submissions while ensuring quality and supply for Praxis programs with an entrepreneurial, agile mindset.