Focused patient recruitment.

Senior Manager, Analytical Development

ManagerManagerFull TimeRemoteTeam 11-50Since 2002H1B SponsorCompany Site LinkedIn

Location

United States

Posted

52 days ago

Salary

$140K - $160K / year

Bachelor Degree10 yrs expEnglish

Job Description

• Involved in supporting analytical deliverables of the CMC programs while working in conjunction with CMC team members. • Management of analytical testing in our external network, especially as it relates to GMP drug substances and drug products. • Ensuring that analytical documentation (protocols, reports, methods, COAs, change controls, etc.) are added contemporaneously to Praxis’ document management system. • Oversight and coordination of CMC stability and reference standard programs. • Direct monitoring of our external network providers that execute Analytical Development activities to ensure deliverables and continuously improve efficiency. • Supporting 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. • Collaborate with other functions of Praxis CMC to establish the technical and business practices of the team.

Job Requirements

Bachelor’s degree in Analytical Chemistry or related discipline with 10+ years of industry experience; Master’s degree or equivalent a plus.
Industry experience in Analytical Development specifically for small molecule drug substance as well as solid and liquid oral drug products is required.
Strong attention to detail along with the ability to perform meticulous data review and data transcription review.
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 CDMO partners and associated service providers.
Fluid and conversant with GMP and quality control.
Demonstrates a high level of intellectual curiosity, innovation, and creative problem solving with an entrepreneurial spirit.
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.