MENARINI Group · 16 hours ago
Principal Scientist, Analytical Development
UNAVAILABLE, NY, US
Full-time
Hybrid
Lead/Staff
$160K/yr - $200K/yr
10+ years expMENARINI Group is an Italian pharmaceutical company dedicated to innovation and advancement in therapeutics and diagnostics. The Principal Scientist in Analytical Development will manage the analytical aspects of Stemline Therapeutics portfolio projects, ensuring the timely delivery of analytical methods and data analysis to support drug substance and product requirements.
BiotechnologyMedicalPharmaceutical
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 Group
Besides Italy, where Menarini is one of the leading pharmaceutical groups, sales are mainly concentrated in Europe: Austria, Benelux,
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Elcin Barker Ergun
CEO
Recent News
Longevity.Technology
2026-02-05
GlobeNewswire
2026-01-11
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