Principal Scientist, Analytical Development

Role Summary

Lead analytical development for Praxis' clinical and commercial pipelines, translating processes from the laboratory to manufacturing within a virtual development and CMO network. Own analytical method development, qualification, validation, troubleshooting, data interpretation, and documentation (CoA, stability reports). Collaborate with Drug Substance/Drug Product, Quality, and manufacturing to ensure efficient, well-controlled products and processes. Drive an agile analytical function to support CMC and enable Praxis’ pipeline of neurological disease medicines. Location: Remote; travel as needed.

Responsibilities

• Act as Analytical Lead for the CMC program; manage and execute analytical testing for the Analytical Development team and external network, focusing on method development, validation, and GMP testing; perform troubleshooting, data interpretation, review method validation documents, author CoA, and stability reports.
• Direct management of external network providers performing Analytical Development activities to ensure deliverables and continuous efficiency improvements.
• Lead the design and development of phase-appropriate quality control strategies, specifications, and stability studies for drug substance and drug product.
• Contribute to the overall CMC team in terms of execution and development of our CMC operations function, and process improvement.
• Collaborate with other Praxis CMC functions to establish the technical and business practices of the team.

Qualifications

• Required: Advanced degree (PhD or Masters) in Analytical Chemistry or related discipline with 5-7 years of industry experience.
• Preferred: Biopharmaceutical innovator or CMO experience.
• Required: Industry experience in Analytical Development specifically for small molecule drug substance and solid oral drug products.
• Preferred: Experience with oligonucleotide drug substance and/or drug products.
• Required: Strong knowledge of US and EU cGMP requirements and best practices relating to drug substances and drug products.
• Required: Ability to interpret and implement, as appropriate, compendia-based testing requirements for drug substances and drug products.
• Required: Involvement in reference standard management and stability oversight.
• Preferred: Experience with CMC development and support across all phases of drug development from initial regulatory filings through registration, validation and launch.
• Preferred: Experience in support of late-stage / commercial products including product monitoring, improvement and issue resolution.
• Preferred: Demonstrated success in building and maintaining productive partnerships with third-party CRO/CMO partners and associated service providers to develop and manufacturing pharmaceutical products.
• Required: Fluid and conversant with GMP and quality control.
• Preferred: Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment.
• Preferred: Excellent interpersonal and communication skills, with the ability to develop important relationships that include trust and encourage diversity in all its forms.
• Preferred: Highly organized and detail-oriented with a passion to deliver quality results.

Education

• PhD or Masters degree in Analytical Chemistry or related discipline.

Additional Requirements

• Physical and mental requirements include regular use of a computer and office equipment, clear communication, and occasional movement; comfortable with screen work, basic hand coordination, and focus. Reasonable accommodations may be provided to enable individuals with disabilities to perform these functions.