Menarini Stemline
Principal Scientist, Analytical Development
Overview
Job title: Principal Scientist, Analytical Development
Reports to: AVP, Formulation Development-Manufacturing CMC
Manage the analytical aspect of Stemline Therapeutics portfolio projects with the responsibility to serve as an analytical subject matter expert and to oversee the timely delivery of analytical methods and data analysis to support uninterrupted supplies of drug substances and products that meet the established acceptance criteria for clinical and commercial requirements.
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.
Qualifications
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
Base Salary Range of $160,000-$200,000. Menarini Stemline offers generous compensation and benefits packages, including Short-Term Incentive, Fidelity 401(k) (with company match), Anthem Premier PPO and HDHP insurance plans, Company-paid Basic Life & AD&D insurance and pre-tax FSA/HSA programs.
Menarini Stemline is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
Seniorities and Employment
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Research, Analyst, and Information Technology
Industries: Biotechnology
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Job title: Principal Scientist, Analytical Development
Reports to: AVP, Formulation Development-Manufacturing CMC
Manage the analytical aspect of Stemline Therapeutics portfolio projects with the responsibility to serve as an analytical subject matter expert and to oversee the timely delivery of analytical methods and data analysis to support uninterrupted supplies of drug substances and products that meet the established acceptance criteria for clinical and commercial requirements.
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.
Qualifications
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
Base Salary Range of $160,000-$200,000. Menarini Stemline offers generous compensation and benefits packages, including Short-Term Incentive, Fidelity 401(k) (with company match), Anthem Premier PPO and HDHP insurance plans, Company-paid Basic Life & AD&D insurance and pre-tax FSA/HSA programs.
Menarini Stemline is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
Seniorities and Employment
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Research, Analyst, and Information Technology
Industries: Biotechnology
#J-18808-Ljbffr