Sr. Engineer/Scientist III, Manufacturing Sciences

Biogen•Research Triangle Park, NC

About The Position

As a member of Manufacturing Sciences, the Sr. Engineer III 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 key leader for investigations and project implementation for Manufacturing Sciences using their technical expertise on fill/finish, visual inspection, and packaging. The Sr. Engineer III, Manufacturing Sciences will provide technical expertise to the clinical, PPQ, and commercial manufacturing campaigns run at the site. As appropriate, responsibilities include: Knowledge of parenteral filling (vials, cartridges, syringes) operations, lyophilization, and visual inspection activities Lead Process & Technology Transfer teams, technical improvement projects, and technical process investigations as needed. Provide technical and operational guidance to Manufacturing during GMP campaigns Lead technical investigations towards process impact assessments and ensure timely completion and communication Author Manufacturing and Process Performance Qualification validation protocols and technical reports. Lead technical projects towards improved facility capabilities, efficient systems, improved technical competency, or increased process/scale-up understanding. Cultivate continuous improvement environment within the process transfer teams at the RTP site and benchmark tech transfer best practices both internal and external to Biogen, as appropriate Subject matter Expert to support inspections and audits Lead complex process investigations while servicing as the point of contact to broader organization. Perform data analysis to support process improvements or process transfers. Manage technical projects providing value to the Pharma site. Project Management experience in order to facilitate meetings with various stakeholders and communicate to management on the status of programs.

Requirements

Bachelors degree in Engineering or relevant scientific/technical discipline with a minimum of 8 years of relevant experience is required OR Masters degree in Engineering or relevant scientific/technical discipline with a minimum of 6 years of direct experience OR Ph.D. in Engineering or relevant scientific/technical discipline with a minimum of 4 years of direct experience
Excellent communication and project management skills appropriate for leadership of tech transfer projects
Expertise in technical understanding of Parenteral Filling Operations (e.g. Filling Isolator, Lyophilizer, Visual Inspection) including transfer of such processes into full-scale drug product manufacturing facilities
Excels at working in a team environment
Comfortable analyzing scientific datasets/strong analytical skills with excellent written skills
Ability to work independently and lead a large cross-functional group
Knowledge of cGMP, FDA/EMA regulations, Process Performance Qualification, Continued Process Verification

Responsibilities

Knowledge of parenteral filling (vials, cartridges, syringes) operations, lyophilization, and visual inspection activities
Lead Process & Technology Transfer teams, technical improvement projects, and technical process investigations as needed.
Provide technical and operational guidance to Manufacturing during GMP campaigns
Lead technical investigations towards process impact assessments and ensure timely completion and communication
Author Manufacturing and Process Performance Qualification validation protocols and technical reports.
Lead technical projects towards improved facility capabilities, efficient systems, improved technical competency, or increased process/scale-up understanding.
Cultivate continuous improvement environment within the process transfer teams at the RTP site and benchmark tech transfer best practices both internal and external to Biogen, as appropriate
Subject matter Expert to support inspections and audits
Lead complex process investigations while servicing as the point of contact to broader organization.
Perform data analysis to support process improvements or process transfers.
Manage technical projects providing value to the Pharma site.
Project Management experience in order to facilitate meetings with various stakeholders and communicate to management on the status of programs.

Benefits

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation