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Principal Scientist, Analytical Development

Research ScientistResearch ScientistFull TimeRemoteTeam 11-50Since 2002H1B SponsorCompany Site LinkedIn

Location

United States

Posted

48 days ago

Salary

$162K - $182K / year

Postgraduate Degree5 yrs expEnglish

Job Description

• Responsible for translating the processes and products for Praxis’ clinical and commercial pipeline from the laboratory to the manufacturing environment. • Use 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 to ensure efficiency and control. • Lead contributing to ensuring the analytical function is agile and at the forefront in the industry. • Deliver to product teams within CMC to realize Praxis’ pipeline of innovative medicines for neurological disease. • Involved in all analytical deliverables with CMC program while acting as Analytical lead, including management and execution of analytical testing.

Job Requirements

Advanced degree (PhD or Masters degree with related experience) in Analytical Chemistry or related discipline with 5-7 years of industry experience.
Industry experience in Analytical Development specifically for small molecule drug substance and solid oral drug products is required.
Experience with oligonucleotide drug substance and/or drug products desirable.
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.