The Engineer III, Mfg. Sciences is responsible for creating, updating and communicating technology transfer deliverable schedule and metrics for manufacturing sciences and partner departments. Must be able to analyze complex issues and define potential solutions with minimal guidance. Must concisely and accurately communicate departmental priorities to stakeholders and assist in aligning team priorities. Must be able to evaluate metrics and identify business process redesign opportunities.
As appropriate, responsibilities include:
Lead programs and support technology transfer projects into cGMP production areas. Coordinate and lead meetings attend sub team meetings as necessary and manage information flow and decisions in project. Ensure the customers and key stakeholders are informed of the timing of activities and their responsibilities related to the Tech Transfer process.
Integrate the tech transfer project schedule with other scheduling functions, so the schedule can easily be seen and used by other teams.
Coordinating reports/ data in support of Deviations, CAPAs, presentations, technology transfer optimization and business decisions. Support optimization projects towards improved business process flows. Measure and evaluate impact of problem, provides suggested options and implementation plans. Lead the implementation of the agreed upon enhanced processes and monitor effectiveness of new process.
Education: Biochemistry, Bioengineering, Biochemical, Chemical Engineering or related discipline: Ph.D. with 0-3 years of experience, M.S. with 2-4 years' experience or BA/BS 4-6 yrs. relevant experience in the Biotech / Biopharm industry.
Ability to work independently and work as part of a large cross-functional group.
Effective communication and project management skills appropriate for leadership of technology transfer projects.
Ability to work well in both in an individual and leadership capacities
Knowledge of cGMP, FDA/EMA regulations, Process Validation
All your information will be kept confidential according to EEO guidelines.