Job Detail

Job Description

• Responsible for leading, facilitating, or coordinating all activities pertaining to tech transfer, which includes  process transfer, manufacturing readiness, production and testing, material disposition, and tech transfer/project closeout


• Coordinate and lead tech transfer meetings, attend process subteam meetings as necessary, and manage information flow and decisions within multiple tech transfers


• Own the tech transfer project schedule and integrate this with other scheduling functions, so the schedule is visible and usable by relevant stakeholders


• Proactively inform Senior management/Site Leadership Team/Asset team of milestone progress and any upsetting program delays


• Lead optimization projects resulting in improved (simplified, more robust, or clearer) business processes. Leads the implementation of the agreed-upon solutions and monitors effectiveness of new process(es)


• Cultivate relationships with external business partners and internal stakeholder groups, including (but not limited to) manufacturing, engineering, automation, technical development, quality, materials, site planning, technical operations, asset leaders, and supply chain planning


• Represent tech transfer in factory leadership teams and asset teams and present high level project risks, milestones, and stage gates to senior leadership

Qualifications

• Bachelor’s degree or equivalent advanced technical degree in pharmaceutical technology, engineering (chemical, pharmaceutical or biotechnology) or equivalent science study. Project Management certification (e.g., PMP), Business, or Master’s degree preferred.


• Minimum 6 years of experience within biologics development, manufacturing, and/or a relevant project management function


• Must possess exceptional communication skills and be able to influence across, down, and up. This role requires the capability to influence without authority and demonstrated competency with conflict resolution


• Must be comfortable leading change and be willing to challenge the status quo (including the established status quo within the tech transfer department)


• Possess enthusiasm for learning, a continuous improvement mindset, and relentless curiosity


• Proficiency with all MS Office applications, particularly MS Project, MS SharePoint, and MS Excel. Basic programming capabilities (Visual Basic for Applications, JavaScript, SQL, etc.), while not required, are a big plus

Additional Information

The Senior Engineer I, Mfg. Sciences is responsible for creating, updating, and communicating technology (tech) transfer deliverables, the overall tech transfer schedule, and applicable tech transfer metrics. The incumbent must be able to analyze complex issues and identify business process optimization opportunities. This role requires the capability to lead large, cross-functional teams towards a common goal. Must concisely and accurately articulate departmental priorities to stakeholders and assist in aligning departmental and project priorities.