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Sr. CMC Project Manager
Ref No.: 18-00851
Location: Morris Plains, New Jersey
Position Type:Direct Placement
Senior Manager, Pharmaceutical Quality/CMC Project Management
Morris Plains, NJ

The Senior Manager, Pharmaceutical Quality/CMC Project Management will provide chemistry, manufacturing, and control (CMC) cross-functional strategic direction and tactical management for the company's lead development program. The candidate will establish and lead the technical sub teams to build and execute CMC strategies integrated with the overall program objectives and timelines. S/he will work with internal and external stakeholders to define, manage, and interpret results for CMC-related activities in support of global clinical development and registration. The individual may serve as the CMC area technical expert on program teams and is responsible for setting CMC objectives, budgets, and timelines in alignment with registration strategies.

  • Provides CMC leadership, tactical oversight, and strategic guidance to program team and management to support global program development.
  • Manages the integration of defined CMC activities within CMC sub teams and with the overall program development teams; keeps the team aligned for successful and timely accomplishment of agreed objectives.
  • Builds detailed CMC timelines with clarity to assumptions, risks, and decision points; leads the team to complete written CMC development strategies, and provide recommendations for core team or management endorsement.
  • Serves as a CMC contributor and reviewer of regulatory documents and communications for R&D programs.
  • Through cross-functional leadership, defines CMC area objectives, budgets, and resource plans for established program development strategies; actively manages the CMC budget for programs through collaboration with consultants, contractors, and internal associates.
  • Facilitates effective and open communication between assigned CMC sub teams and their stakeholders.
  • Regularly meets with CMC functional leads to define strategies and manage tactical execution. Links discrete CMC strategies into a single, comprehensive strategy across the areas of drug substance, drug product, analytical, clinical supply chain, regulatory, and quality. Actively integrates the needs of the overall development program with CMC.
  • Works collaboratively with the CMC Technical Lead.
  • Establishes and leads cross-functional CMC teams for assigned programs. Prepares for and runs regularly scheduled meetings. Provides technical project management including elements such as Gantt and budget development, critical path analysis, and risk mitigation. 
  • Provides critical analysis of program challenges and opportunities and recommends mitigation plans where necessary.
  • As appropriate, supports preparation of RFPs and assesses technical capabilities for vendor selection; may perform technical audits of CMC vendors. May provide oversight and technical management of certain contracted CMC activities.
  • Provides leadership to ensure scientific excellence in study design, data collection, and interpretation, and management within scope to prospectively agreed objectives, budget, and timelines.
  • Together with the CMC sub team, prepares and keeps current written CMC development strategies in alignment with overall program objectives; presents results and progress of CMC programs to internal and external audiences as appropriate.
  • Provides expert scientific or QC review of CMC sections of regulatory documents; may provide drafts for needed CMC-regulatory amendments.

  • Strong technical/analytical skills to identify and solve problems in a fast-paced environment.
  • Working knowledge of cross-functional drug development processes, FDA/ICH/EMA guidelines, and cGMPs.
  • Working knowledge of CMC development strategies across IND-BLA stages.
  • Experience in preparation and submission of CMC documents in support of regulatory filings.
  • Demonstrate project management experience and skills.
  • Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company, vendors, and contract sites.
  • Strong organizational skills in order to maintain a high level of productivity, innovation, and setting priorities in order to complete assignments in a timely manner and within budget.
  • Exhibits high initiative, strong drive, and follow-through.

Job Requirements
  • Requires a Bachelor's degree in a relevant discipline and a minimum 8 years of related experience, which includes experience as a project manager and CMC functional area scientist; or a Master's degree and a minimum 5 years of related experience.
  • Must be proficient with MS Office and MS Project.
  • Proven leadership and cross-functional management of CMC projects.
  • Demonstrated leadership in more than one CMC specialty. Experience with vendor management desired.
  • Requires a flexible work schedule to accommodate program priorities and international activities as needed. 
  • Travel (some international) may be required.