Sr. Manager, Smart Commercialization Team

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The Sr. Manager, Smart Commercialization Team supports PCI Pharma Services by coordinating all end-to-end activities required to move a drug from late-stage clinical development through initial commercialization shipments. This position fully integrates with the customer working with both sponsor and vendors to ensure all commercialization activities are completed on time. The role requires the Sr. Manager to draw from previous commercialization experience to guide the sponsor thorough the entire commercialization process by consulting or, when necessary, leading to ensure product launch occurs within the established timeline.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities are the following but other duties may be assigned.

• Leads all supply chain launch activities needed from final clinical development through commercial launch.
• Provides consultative support to the Sponsor to provide the optimal route for commercialization.
• Performs project management activities such as creating and maintaining timelines; creating and monitoring KPIs for the business, new market entry, and product launches; and coordinating activities and deadlines across functional units to ensure commercial launch happens on time.
• Implements and/or supports clients' supplier relationship management (SRM) business practices.
• Leads and actively manage relationships with key stakeholders within PCI, the Sponsor, and any additional vendors needed to perform commercialization activities.
• Organizes activities to ensure on-time and in-full production and confirmed order shipments.
• Supports the Sales and Operations Planning process across commercial programs.
• Works closely with customers' Commercial Operations and Regulatory Affairs to actively manage label and secondary package design operations including development, proof review/approval, and communication to printed component suppliers.
• Collaborates with customers' team to ensure drug substance and drug product availability and Commercial Operations team to provide forecast data for inventory maintenance.
• Supports clients' regulatory filings by providing input and data such as critical process parameters (CPPs), container closure design master files (DMFs), and component specifications.
• Collaborate with Business Development to ensure that customer commercial demand is aligned with manufacturing capabilities while alleviating resource constraints across the clients' entire product portfolio.
• Participate in the development of target product profiles and ensure alignment across the (Tech Ops) organization.
• Ensure new product introduction plans incorporate multiple launch scenarios and account for any potential changes in strategy.
• Ensure that all pre- and post-launch operational activities are planned and communicated.
• Developing a deep understanding of current and future external supply needs and clearly link supplier utilization to the overall strategy.
• Partner with client forecasting to identify demand assumptions such as sales forecasts and launch planning to develop supply requirements plans.
• Lead business operation launches activities including managing submission business and technical agreements through internal approval process.
• Analyze data to make decisions on printed component supplier selection, adjustments to component inventory holding levels, and other critical operational decisions.
• Assess timeline impacts of any quality and manufacturing issues and work with Quality and Manufacturing teams to facilitate collaborative reviews of deviation investigations.

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor's degree in a related field and 5+ years of experience developing and commercializing drugs.
• Experience launching a commercial product
• College Level Mathematical Skills
• Intermediate Computer
  
  Skills:
  
  Ability to perform more complex computer tasks and has knowledge of various computer programs.
• Full Professional Proficiency:
  Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Very High Reasoning:
  Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
• Ability to Travel (up to 25%)
• Knowledge of and adherence to GMP…