Lead, Large-Scale Purification Operations

Biogen; Milwaukee (WI); On-site; USD 46,000 - 60,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Fitness Reimbursement

Disability Insurance

Vacation

Holidays

Sick Time

Parental Leave

401(k) Match

Stock Purchase Plan

Tuition Reimbursement

Employee Resource Groups

Job summary

Biogen manufacturing lead role performing and documenting daily operations in a cGMP environment, including operation of process equipment and validation protocols. This position coordinates with the shift Supervisor to manage critical activities and prepares for the Manufacturing Supervisor role.

The role involves leading manufacturing steps, scheduling shift tasks, documenting deviations, training, and acting as SME during audits, with 12-hour shifts on a 2-2-3 calendar rotation.

Qualifications

• Bachelor’s degree or equivalent with direct experience
• 4+ years direct experience in manufacturing
• Experience leading manufacturing activities and training associates
• Experience in a cGMP environment with SOPs, GDP
• Experience with Trackwise/DeltaV/Syncade/LIMS
• Pipetting experience in lab/manufacturing

Responsibilities

• Execute manufacturing steps and monitor against batch records and control system
• Schedule shift tasks and allocate resources; communicate issues at shift exchanges
• Document and review cGMP data; update batch records and logbooks
• Participate in training; develop personal plan and coach others
• Investigate deviations; lead CAPAs and support audits
• Serve as operational contact for shift associates with technical guidance

Skills

Leadership

Shift coordination

Training associates

GDP knowledge

Aseptic/cleanroom

Pipetting

Problem solving

Education

Bachelor’s degree in STEM

BioWorks Certificate or associate's degree

High School Diploma with experience

Tools

Trackwise

DeltaV

Syncade

LIMS

Job description

Biogen manufacturing lead role performing and documenting daily operations in a cGMP environment, including operation of process equipment and validation protocols. This position coordinates with the shift Supervisor to manage critical activities and prepares for the Manufacturing Supervisor role.

The role involves leading manufacturing steps, scheduling shift tasks, documenting deviations, training, and acting as SME during audits, with 12-hour shifts on a 2-2-3 calendar rotation.