Deputy Director MSAT Injectables, Formulation Excellence

Role Summary

Location: Swiftwater, PA. Deputy Director within the Swiftwater MSAT Injectables, Formulation Excellence function, responsible for delivering robust and efficient formulation processes and technology transfer to manufacturing. Drives technical strategy and project deliverables across the Injectables landscape at the site, and ensures compliance with cGMP, quality, regulatory, and health and safety guidelines while supporting industrial performance excellence.

Responsibilities

• Leads projects with significant financial accountability, responsibility, and complexity.
• Liaison between MSAT, Manufacturing, Quality Operations, Project teams, etc., and assist to troubleshoot or resolve any issues that arise.
• Completion of Development, Validation, and Transfer of pharmaceutical technologies for release and stability of clinical and commercial products according to project needs and timelines across the Formulation, Filling, Inspection, and Packaging (FFIP) platform.
• Authoring and reviewing Injectables procedures, development, and validation reports.
• Leadership, within and external to their area of expertise, in the planning, prioritization, and execution of development and validation studies to support the project (i.e. technical transfer and new vaccine introduction), continuous improvement, and manufacturing assist activities related to Formulation.
• Effectively communicate information to site management and senior leadership.
• Supports the site for all internal and external audits and regulatory inspections.

Qualifications

• Required: Bachelors, Master's or Ph.D. in a Scientific discipline, Math, Engineering or Pharmacy.
• Required: 6+ years' experience in biological processes or analytics in a cGMP environment.
• Required: At least 2 years of experience with project management, leading and developing teams.
• Required: Strong knowledge of process validation.
• Preferred: Prior experience within Biopharmaceutical arena is preferred.

Skills

• Behaves according to company values and competencies.
• Influences internally and across VIA functions; forward-thinking with an attitude of optimization, efficiency, continuous improvement, and smooth transitions between functions.
• Proactively anticipates and effectively communicates successes, constraints, conflicts, solutions, and actions for resolution.
• Proactively resolves conflicts, removes roadblocks to execution within the sphere of influence; escalates to functional management, project sponsors, and stakeholders when appropriate.
• Empower and ensure accountability within the project team.

Additional Requirements

• Approximately 10% travel.