Senior Engineer I, Mfg Sciences

Biogen

Job Description

As a member of Manufacturing Sciences, the Sr. Engineer I will provide technical expertise to the clinical and commercial manufacturing campaigns run at the Parenteral Facility Drug Product site. The focus of this position will be as a site technical expert on fill/finish, visual inspection, and packaging.
As appropriate, responsibilities include:
*Provide technical support on process deviations that occur during production.
*Lead technology transfers from Technical Development or external partners to the RTP Drug Product site. Technology transfer will include providing decisions for manufacturing implementation of processes and communicating the decisions to the technology transfer team.
*Perform data analysis and design laboratory/pilot scale experiments to support process improvements or process transfers. Manage technical projects providing value to the DP site.
*Author technical reports, protocols and regulatory documents. Support regulatory audits and internal quality organization towards process and batch review and approval.
*Actively pursue technical improvement projects and implement the changes through the global change control process.
*Ability to communicate status of continuous improvement activities, deviations, technology transfer deliverable schedule and metrics for Manufacturing Sciences PF group to management and partner departments.

Qualifications

*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.
*Comfortable analyzing scientific datasets/strong analytical skills with excellent written skills.
*Ability to work well in both individual and leadership capacities
*Knowledge of cGMP, FDA/EMA regulations, Process Validation

BA/BS 8 yrs relevant experience, M.S. with 6 yrs experience, or Ph.D. with 3 yrs experience in the Biotech / Biopharm industry.
Biochemistry, Bioengineering, Biochemical, Chemical Engineering or related discipline

Additional Information

As a member of Manufacturing Sciences, the Sr. Engineer I will provide technical expertise to the clinical and commercial manufacturing campaigns run at the Parenteral Facility Drug Product site. The focus of this position will be as a site technical expert on fill/finish, visual inspection, and packaging.

NC