Site Services Director

3 weeks ago

Austin, Texas, United States BD Full time
Job Description Summary

This position reports to the Director of Combination Products and Technical Services. As part of the ZebraSci Leadership Team, the Site Services Director is responsible for contributing to the business strategy, directing site technical and scientific activities related to combination product development services, leading all aspects of the Temecula, CA site operations for combination product testing, and ensuring that customer projects are executed efficiently, in compliance with requirements, and with a positive customer experience.

The Site Services Director will serve as a primary contact for pharmaceutical customers and a main point of contact for site visits and audits by customers or regulatory authorities.

Key Responsibilities
  • Serves as a combination products expert and leads customer engagement:
    • Uses technical expertise to contribute to the customer sales process and services delivery, while maintaining a customer-focused outlook
    • Builds strong working relationships with customers to understand, on a deep level, the technical needs and issues and translates these into appropriate responses, solutions, services, and executable action plans
    • Educates and provides customer consultation on technical aspects of combination products and testing services, as appropriate
  • Manages, develops, and drives the Temecula, CA staff including:
    • Supervises the onboarding, scheduling, and delivery of new customers and customer projects, while ensuring customer expectations are exceeded
    • Oversees day-to-day workload, priorities, and timelines
    • Sets goals and provides career support, guidance, mentorship, and development
    • Conducts regular 1:1 and staff sessions for cross-functional feedback
    • Conducts performance reviews (as set by company policy)
    • Performs site succession planning
    • Demonstrates technical expertise to train and guide engineering/scientific staff on the development and execution of combination products testing services
    • Drives internal cross-functional team (business development, quality, service operations) collaboration to discuss and resolve challenges with service projects, provide updates, and ensure execution to plan
    • Participates in development and maintenance of the company's training programs in compliance with cGMP and/or ISO guidelines
  • Responsible for site maintenance, operating requirements, investments, and capabilities development:
    • Responsible for leading all facilities work, leveraging site staff as appropriate
    • Identifies, builds, and maintains an external network of experts/companies to support capabilities development and deployment
    • Assists with site accreditations and renewals as needed
    • Participates, hosts, and conducts internal, customer, and sub-contractor/supplier audits and visits, as needed
    • Manages the site budget and capital investments in conjunction with the Senior Leadership. Tracks and ensures operational efficiency and appropriate staffing of the site
  • Supports business development and captures and translates market insights to drive the business:
    • Ensures site Technology Development team scouts new testing technology trends and stays abreast of changing regulations, standards, and environment relevant to combination products
    • Develops content for technical support, services, and customer experience/journey, as well as represents ZebraSci at major scientific conferences
    • Shares gathered intelligence and technical findings across ZebraSci team, BD network, and 3rd parties as appropriate

Requirements

  • Developed technological skills, including knowledge of drug-device combination products and/or medical devices including market available technologies from major industry suppliers, knowledge of the operation of mechanical measurement equipment (e.g. Instron, Zwick, etc.) and container closure integrity instrumentation, and experience with method validation and test protocol generation, execution, and reporting
  • Knowledge of small-scale filling and component assembly is desirable
  • Deep understanding of design control and system integration is desirable
  • Working knowledge of industry standards and requirements (ex. cGMP)
  • Application of statistical and analytical methods such as Design of Experiments, ANOVA analysis, and statistical software (Minitab, Jump, etc.)
  • Superior communication skills, both written and oral
  • Attention to detail with demonstrated ability to multi-task in a fast-paced environment, manage changing priorities, and communicate effectively across the organization
  • Sophisticated project and time management skills; skilled in driving operations
  • Ability to delegate effectively

Education and Experience

  • BS (MS or PhD degree preferred in a science or engineering discipline) plus proven experience in medical device, IVD and/or pharmaceutical industry working with combination products
  • 10+ years working in a technological or operational role within medical devices and/or pharma combination products with a BS (8+ for MS, 6+ for PhD)
  • People management experience
  • Experience working within a cGMP environment
  • Experience interacting with regulatory agencies and participating in or managing inspections

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