Menarini Stemline · 16 hours ago
Principal Scientist, Analytical Development
New York, United States
Full-time
Hybrid
Lead/Staff
$160K/yr - $200K/yr
10+ years expMenarini Stemline is an Italian pharmaceutical company with a strong commitment to oncology and innovative therapeutic solutions. The Principal Scientist in Analytical Development will manage the analytical aspects of portfolio projects, ensuring timely delivery of analytical methods and data analysis to support drug substances and products for clinical and commercial requirements.
BiotechnologyHealth CareHealth DiagnosticsOncology
Responsibilities
Manage the development, validation and implementation of appropriate biologic and pharmaceutical analytical methods at CDMOs and CROs in support of drug substance and drug product in clinical programs and commercially marketed, with focus on analytical methods for release testing and stability, in process controls/tests, impurity controls, and ongoing API and drug product characterization as needed
Provide technical oversight of outsourced analytical activities to enable timely delivery of supplies for commercial products and portfolio programs
Analyze results, solve analytical issues, and meet regulatory expectations for analytics applied to both small molecule and biologic drug substances and drug products
Author, review and approve change controls, deviations, CAPAs, and risk assessments
Author, review and approve analytical documents such as analytical method development protocols and reports, feasibility study protocols and reports, qualification protocols, validation protocols, transfer protocols, validation reports, methods of analysis, and laboratory investigation reports
Provide on-site presence at CDMOs for audit, training, meetings as needed to achieve objectives
Manage the system for tracking of analytical reference standards and impurities
In collaboration with Regulatory, author relevant Chemistry, Manufacturing and Controls (CMC) sections for drug substances and products. Address and author Regulatory reviewer comments with data supporting responses to enable accurate and timely registrational submissions
Qualification
Required
PhD. or M.S. in Chemistry with 10+ years of related pharmaceutical development experience with focus on biologics
In-depth working knowledge of biologic analytical techniques, analytical method development, method transfer, method validation and stability
Experience in regulatory filings, specifications and controls, analytical method development and validation and the commercialization process
Knowledgeable of ICH guidelines and FDA Guidance related to Pharmaceutical development, validation, manufacturing and stability of drug substance and drug product
Experience in actively managing outsourcing to contract development and manufacturing organizations
Benefits
Short-Term Incentive
Fidelity 401(k) (with company match)
Anthem Premier PPO and HDHP insurance plans
Company-paid Basic Life & AD&D insurance
Pre-tax FSA/HSA programs
Company
Menarini Stemline
The Menarini Group ("Menarini"), a leading Italian pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc.
501-1000 employees
H1B Sponsorship
Menarini Stemline 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
2025 (3)
2024 (3)
2023 (2)
2022 (2)
Funding
Current Stage
Public CompanyTotal Funding
$195.09MKey Investors
Pequot Capital
2020-05-04Acquired
2019-08-01Post Ipo Equity· $88M
2019-01-15Post Ipo Equity· $92M
Leadership Team
David Gionco
Vice President of Finance and Chief Accounting Officer
Ahmed Rabie
Chief Commercial Officer
Recent News
2025-10-13
Company data provided by crunchbase