Project Manager II

Job Description

Job Summary:

• The MSAT Synthetics team at Client 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 Client group divisions including Commercial Global Business Units, R&D, Regulatory, and Alliance Management.
• We collaborate closely with various internal Client 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.

Main Accountabilities:

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 Client 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.

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.

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.

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.

Other Skills:

• Proficiency in MS Office (Word, Excel, PowerPoint, Project).
• Solid writing and presentation skills.
• Excellent organizational and communication skills.

Top required skills:

• Combined min 7 years of related experience; with required BS/ MS degree, PHD preferred.
• Must have recent experience with small molecules and pharmaceutical development/ synthesis
  Small molecule vs. Biological/ vaccines, not applicable.
• Chemistry and Pharmaceutical Development.
• Previous experience as Senior Research Associate Director, Process Development Lead CMC/ Associate
• Research Scientist.

Nice to have Skills:

• Veeva experience is a plus.