Director, Process Chemistry (Remote)

Praxis Precision Medicines; United States; Teletrabalho; USD 215 000 - 235 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical/dental/vision coverage

401(k) with matching

Stock incentives

Discretionary quarterly bonus

Generous PTO

Company-wide shutdowns

Resumo da oferta

Praxis Precision Medicines is seeking a Director of Process Chemistry to lead drug substance activities across multiple projects. You will design and mature processes from early lab work to pilot plant, ensuring regulatory readiness and seamless collaboration with the CMC and project teams.

The ideal candidate has 12+ years in CMC for small molecules, strong cGMP knowledge, and a track record of delivering robust manufacturing strategies in an agile environment.

Qualificações

• Advanced degree or commensurate experience in Chemistry, Pharmaceutical Sciences, Engineering or related discipline.
• Minimum of 12 years of industry experience in CMC specifically for small molecule drug substance.
• Strong knowledge of US and EU cGMP requirements for drug substances and drug products.
• Experience with CRO/CMO partners and related service providers.
• Experience with salt/crystalline form selection.
• Oligonucleotide chemistry experience is a plus.
• Demonstrates entrepreneurial spirit with an agile, collaborative mindset.
• Excellent interpersonal and communication skills for cross-functional teamwork.

Responsabilidades

• Lead Process Chemistry R&D for one or more projects from early to late phase.
• Design early and late-phase/commercial drug substance processes and demonstrate from lab to pilot plant.
• Provide chemistry leadership across lifecycle, from discovery to regulatory readiness.
• Collaborate with formulations, analytical, operations, engineering and quality teams within the CMC group.
• Coordinate with external CRO/CMO partners to meet delivery timelines.
• Analyze external data to guide synthetic plans at CROs/CDMOs.
• Author or co-author regulatory submissions.
• Define manufacturing strategy including GMP requirements and issue resolution.
• Assess new trends in process development, quality and manufacturing for Praxis products.
• Manage budgeting for drug substance activities on a quarterly basis.
• Contribute to IP value through inventions.

Conhecimentos

Continuous processing

Biocatalysis

Catalysis

High throughput experimentation

cGMP knowledge

CMC development

CRO/CMO collaboration

Oligonucleotide chemistry (plus)

Entrepreneurial/Agile mindset

Formação académica

Advanced degree in Chemistry or related field

Descrição da oferta de emprego

Praxis Precision Medicines is seeking a Director of Process Chemistry to lead drug substance activities across multiple projects. You will design and mature processes from early lab work to pilot plant, ensuring regulatory readiness and seamless collaboration with the CMC and project teams.

The ideal candidate has 12+ years in CMC for small molecules, strong cGMP knowledge, and a track record of delivering robust manufacturing strategies in an agile environment.