What are the responsibilities and job description for the Technical Leader, MSAT CMC Development position at Aequor?
Title:- Technical Leader, MSAT CMC Development
Location: Cambridge, MA (Hybrid)
Duration: Contract until April 2027 (Possible extension)
Job ID:- SNFIJP00011050
Description:
Hybrid
2.2 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
Section 4: 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
MINAKSHI SANGWAN
Recruiting Lead - US Recruitment
O 732-339-3518
E Minakshi.sangwan@aequor.com
W http://www.aequor.com/