Technical Leader, MSAT CMC Development
Spectraforce Technologies, Cambridge, MA, United States
Overview
Position Title:
Technical Leader, MSAT CMC Development
Work Location:
Cambridge, MA 02141
Assignment Duration:
12 Months
Work Arrangement:
Hybrid
Main Accountabilities A. CMO/CRO Management
Prepare summaries of proposals, reports and data from CMOs/CROs for projects and present to management for review
Obtain and organize necessary technical information to support projects at internal sites or CMO/CROs
Provide technical support to manufacturing sites for significant deviations and drive process and product life cycle management improvements for process robustness and yields
Assist with reviewing contracts (CDSs, MSAs, Quality Agreements) and quotations to support CMC development projects, industrial technical projects and internal industrial development programs
B. Technical Management
Execute 2nd generation program technical strategies to the MSAT Technical Product Team, focused on synthetic process development and/or pharmaceutical development of oral dosage forms for small molecules
Implement product control strategies in compliance with overall regulatory/quality requirements
Select appropriate QbD strategies, process parameter risk assessments, and application of prior knowledge
Conduct risk assessments for project activities and outline contingency plans
Draft product- and process-specific technical reports to support life-cycle management activities
Support MSAT Program Directors and CMC Leaders with planning, coordinating and following activities for the various types of projects
Assist with reviewing and finalizing technical documents such as protocols, reports and regulatory dossier content
C. Project Management
Organize meetings and prepare project updates for project teams and M&S management
Create and maintain detailed timelines and project plans with input from Program Directors / CMC Leaders
Organize meetings with project teams for status updates and action items follow-up to ensure adherence to timelines
Organize meetings with sponsors (R&D, GBU, M&S Teams) to communicate project updates
Create and maintain detailed project plans with gating / milestones
Required Skills & Qualifications 4.1 Education & Experience
BS/MS in Chemistry or PhD (preferred), Pharmacy or Life Sciences required;
Minimum 7 years of experience in technical project management, pharmaceutical development, technical operations and/or manufacturing of small molecules and/or of drug product dosage forms for small molecules
Demonstrated experience as a technical project manager with ability to facilitate multi-disciplinary teams
Experience with international project teams is a plus
Quality and/or Regulatory background highly desirable
4.2 Other Skills
Proficiency in MS Office (Word, Excel, PowerPoint, Project)
Solid writing and presentation skills
Excellent organizational and communication skills
Nice to have Skills
Veeva experience is a plus
Descripion The MSAT Synthetics team is dedicated to supporting CMC Development and Pharmaceutical Technical activities for new R&D compounds, Life Cycle Management Programs (LCM), product territory extensions, and industrial technical projects. Our team plays a critical role in coordinating multiple technical aspects of MSAT and Manufacturing and Supply (M&S) Programs through organization and alignment with other group divisions including Commercial Global Business Units, R&D, Regulatory, and Alliance Management. We collaborate closely with various internal support laboratories and external contract organization facilities. Our focus includes development activities supporting the small molecule portfolio, encompassing drug substance process development and pharmaceutical development for oral dosage forms such as tablets and suspensions. As products approach the registration and launch stage, we work closely with M&S Sites, Supply Chain, CMOs (through External Manufacturing), and Alliance Partners to outline comprehensive plans and activities.
4.2 Education & Experience (cont.)
2.2 Main Accountabilities
Note: The following sections summarize responsibilities related to the role and the environment; all content is retained from the original description for accuracy.
#J-18808-Ljbffr
Technical Leader, MSAT CMC Development
Work Location:
Cambridge, MA 02141
Assignment Duration:
12 Months
Work Arrangement:
Hybrid
Main Accountabilities A. CMO/CRO Management
Prepare summaries of proposals, reports and data from CMOs/CROs for projects and present to management for review
Obtain and organize necessary technical information to support projects at internal sites or CMO/CROs
Provide technical support to manufacturing sites for significant deviations and drive process and product life cycle management improvements for process robustness and yields
Assist with reviewing contracts (CDSs, MSAs, Quality Agreements) and quotations to support CMC development projects, industrial technical projects and internal industrial development programs
B. Technical Management
Execute 2nd generation program technical strategies to the MSAT Technical Product Team, focused on synthetic process development and/or pharmaceutical development of oral dosage forms for small molecules
Implement product control strategies in compliance with overall regulatory/quality requirements
Select appropriate QbD strategies, process parameter risk assessments, and application of prior knowledge
Conduct risk assessments for project activities and outline contingency plans
Draft product- and process-specific technical reports to support life-cycle management activities
Support MSAT Program Directors and CMC Leaders with planning, coordinating and following activities for the various types of projects
Assist with reviewing and finalizing technical documents such as protocols, reports and regulatory dossier content
C. Project Management
Organize meetings and prepare project updates for project teams and M&S management
Create and maintain detailed timelines and project plans with input from Program Directors / CMC Leaders
Organize meetings with project teams for status updates and action items follow-up to ensure adherence to timelines
Organize meetings with sponsors (R&D, GBU, M&S Teams) to communicate project updates
Create and maintain detailed project plans with gating / milestones
Required Skills & Qualifications 4.1 Education & Experience
BS/MS in Chemistry or PhD (preferred), Pharmacy or Life Sciences required;
Minimum 7 years of experience in technical project management, pharmaceutical development, technical operations and/or manufacturing of small molecules and/or of drug product dosage forms for small molecules
Demonstrated experience as a technical project manager with ability to facilitate multi-disciplinary teams
Experience with international project teams is a plus
Quality and/or Regulatory background highly desirable
4.2 Other Skills
Proficiency in MS Office (Word, Excel, PowerPoint, Project)
Solid writing and presentation skills
Excellent organizational and communication skills
Nice to have Skills
Veeva experience is a plus
Descripion The MSAT Synthetics team is dedicated to supporting CMC Development and Pharmaceutical Technical activities for new R&D compounds, Life Cycle Management Programs (LCM), product territory extensions, and industrial technical projects. Our team plays a critical role in coordinating multiple technical aspects of MSAT and Manufacturing and Supply (M&S) Programs through organization and alignment with other group divisions including Commercial Global Business Units, R&D, Regulatory, and Alliance Management. We collaborate closely with various internal support laboratories and external contract organization facilities. Our focus includes development activities supporting the small molecule portfolio, encompassing drug substance process development and pharmaceutical development for oral dosage forms such as tablets and suspensions. As products approach the registration and launch stage, we work closely with M&S Sites, Supply Chain, CMOs (through External Manufacturing), and Alliance Partners to outline comprehensive plans and activities.
4.2 Education & Experience (cont.)
2.2 Main Accountabilities
Note: The following sections summarize responsibilities related to the role and the environment; all content is retained from the original description for accuracy.
#J-18808-Ljbffr