Praxis Precision Medicines, Inc. · 1 day ago
Senior Manager, Analytical Development
United States
Full-time
Onsite
Senior Level, Lead/Staff
$140K/yr - $160K/yr
10+ years expPraxis Precision Medicines, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders. The Senior Manager, Analytical Development will oversee analytical projects, manage external testing networks, and collaborate with various teams to ensure efficient and well-controlled processes for drug substances and products.
Alternative MedicineBiotechnologyHealth CareMedicalPrecision Medicine
Responsibilities
Involved in supporting analytical deliverables of the CMC programs while working in conjunction with CMC team members and functional leads. This includes management of analytical testing in our external network, especially as it relates to GMP drug substances and drug products and may include review of raw data, calculations, method validation documents, and stability reports; authoring analytical methods, CoAs, and reports; documenting, implementing, and monitoring change controls
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
Qualification
Required
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 (e.g., capsules, tablets, oral suspensions) 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
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
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 CDMO partners and associated service providers to ensure the company's objectives are achieved
Benefits
99% of the premium paid for medical, dental and vision plans.
Company-paid life insurance
AD&D
Disability benefits
Voluntary plans to personalize your coverage.
Match dollar-for-dollar up to 6% on eligible 401(k) contributions
Long-term stock incentives
ESPP
Discretionary quarterly bonus
Extremely flexible wellness benefit
Generous PTO
Paid holidays
Company-wide shutdowns
Company
Praxis Precision Medicines, Inc.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.
51-200 employees
H1B Sponsorship
Praxis Precision Medicines, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Eventide
2026-01-06Post Ipo Equity· $575M
2025-10-16Post Ipo Equity· $525M
2024-03-28Post Ipo Equity· $200M
Leadership Team
Marcio Souza
President and CEO
Tim Kelly
Chief Financial Officer
Recent News
GlobeNewswire
2026-01-13
2026-01-11
Company data provided by crunchbase