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Project Management & Operational Excellence Lead

Project Management & Operational Excellence Lead

About us

Viralgen is a CDMO born as a joint venture between AskBio and Columbus Venture Partners created in response to the unmet need for manufacturing of gene therapies. Our goal is to help broaden the access to these life-saving therapeutics and contribute to the advancement of health and human welfare around the world.

We are excited for our next Project Management & Operational Excellence Lead to join the Viralgen team!

About the role

We are seeking a Project Management & Operational Excellence Lead who will:

  • Drive project portfolio management approach across Viralgen including the digitalization project management tools and activities.
  • Identify and lead the implementation of operational improvement projects across Viralgen.
  • Drive people development and instill operational excellence mindset and capability.

Responsibilities

  • Actively participates in the identification and implementation of operational improvements intended to optimize existing processes, operational capacity and ensure achievement of cGMP quality and compliance requirements.
  • Identifies areas for Continuous Process Improvements and apply operational excellence tools to reduce operational wastes, process variability and steadily deliver measurable effectiveness and efficiency gains.
  • Shares findings and recommendations for improvement with the teams. And jointly research new methods and or ways of working, including developing new and revised Standard Operating Procedures or systems/ applications.
  • Applies project management skills and concepts to lead or manage projects with an interdisciplinary project team, from planning to project completion and monitoring.
  • Establishes the project portfolio management approach, and roll-out of digital Project Management and controlling tool (e.g. PlanView).
  • Actively provides coaching and mentoring to team leads, associates by involving relevant colleagues in issue identification and resolution; and project definition and setup.
  • Work closely with key internal stakeholders sch as Development & clinical manufacturing operations, Commercial manufacturing operations, Engineering, Project Management.
  • Collaboration with the Digital & IT team.
  • Fostering a dynamic, communicative and respectful work culture within the team and between different departments.

About you

  • Master’s degree from an accredited institution, preferably in Bioscience or engineering related field, minimum of 3 years’ hands on experience in a cGMP Biotech/Pharma manufacturing environment.
  • Strong organizational skills and ability to manage multiple tasks at one time and meet timelines.
  • Experience with manufacturing root cause analysis, corrective/preventive actions (CAPA), performing gap assessments, lean methodology (Black or green Belt), and production planning/scheduling concepts are preferred.
  • Demonstrated fast learning ability, attention to detail, organized analytical thinker with a high level of energy and self-motivation.
  • Ability to read, develop and understand procedures and other controlled documents.
  • Must have excellent written and verbal communication skills.
  • Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities across our organization e.g. development, clinical and commercial manufacturing.
  • Demonstrate a pragmatic and flexible attitude.
  • Strong cross-cultural sensitivity, fostering an inclusive and diversity mindset.
  • Demonstrated ability to work well under pressure and meet tight deadlines.
  • Demonstrated passion for producing high-quality work.
  • Demonstrated proficiency in MS Office programs and associated computer programs.
  • Fluent in English and Spanish, both written and spoken.
  • Proactive and positive attitude to change and challenges.
  • You are self-motivated and used to work in a multidisciplinary environment.
  • Demonstrated ability to work both independently and in a team environment.
  • Demonstrated ability to work well under pressure and meet tight deadlines.
  • Demonstrated passion for producing high-quality work.
  • Proactive management and positive attitude to change and challenges.
  • Communication skills and self-management.