Principal Scientist, Analytical Development

Praxis Precision Medicines, Inc.

7d • Remote

About The Position

Responsible for translating the processes and products for Praxis’ clinical and commercial pipeline from the laboratory to the manufacturing environment in our virtual development and CMO network. The individual will use his or her knowledge of analytical method development, qualification, validation, and troubleshooting to deliver to Analytical Team. Strong collaboration with Drug Substance/Drug Product scientists, engineers, Quality and manufacturing will be needed to ensure our product and processes are efficient and well controlled. S/he will be a leader contributing to ensuring the analytical function is agile and at the forefront in the industry. This mission-critical role will deliver to product teams within CMC to realize Praxis’ pipeline of innovative medicines for neurological disease.

Requirements

• Advanced degree (PhD or Masters degree with related experience) in Analytical Chemistry or related discipline with 5-7 years of industry experience. Preferred with biopharmaceutical innovator or CMO.
• Industry experience in Analytical Development specifically for small molecule drug substance and solid oral drug products is required
• Strong knowledge of US and EU cGMP requirements and best practices relating to drug substances and drug products
• Ability to interpret and implement, as appropriate, compendia-based testing requirements for drug substances and drug products
• Involvement in reference standard management and stability oversight
• 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
• Fluid and conversant with GMP and quality control
• Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment.
• Excellent interpersonal and communication skills, with the ability to develop important relationships that include trust and encourage diversity in all its forms.
• Highly organized and detail-oriented with a passion to deliver quality results.
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Nice To Haves

• Experience with oligonucleotide drug substance and/or drug products desirable

Responsibilities

• Involved in all analytical deliverables with CMC program while acting as Analytical lead, including management and execution of analytical testing and for the Analytical Development team and our external network, especially as it relates to method development, validation and GMP testing. This includes technical troubleshooting, data interpretation, reviewing method validation documents, authoring CoA-s, stability reports.
• Direct management of our external network providers that execute Analytical Development activities to ensure deliverables and continuously improve on efficiency.
• Leading 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 but also development of our CMC operations function, process improvement.
• Collaborate with other functions of Praxis CMC to establish the technical and business practices of the team.

Benefits

• 99% of the premium paid for medical, dental and vision plans.
• company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage
• dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP
• discretionary quarterly bonus
• extremely flexible wellness benefit
• generous PTO
• paid holidays and company-wide shutdowns

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 101-250 employees