Senior Manufacturing Lead — Overnight Shift (cGMP)

BioSpace; New Albany (OH); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Comprehensive benefits package

Stock-based incentives

Award-winning time-off plans

Job summary

Amgen is seeking a Manager, Manufacturing for a 12-hour PM shift to lead a manufacturing area in an Inspection and Packaging facility. You will manage production, ensure cGMP compliance, hire, train, and develop staff, and coordinate with QA/QC, PPIC, and Regulatory teams to meet schedules.

The role demands strong leadership, regulatory interaction, and ability to optimize processes. The position emphasizes supervising staff, developing SOPs, and maintaining safety standards while aligning with

Qualifications

• Doctorate degree required or
• Masters degree with 3 years of relevant industry experience or
• Bachelors degree with 5 years of relevant industry experience or
• Associates degree with 10 years of relevant industry experience or
• High School Diploma/GED with 12 years of relevant industry experience.

Responsibilities

• Maintain production in full cGMP compliance.
• Supervise, hire, and develop staff; ensure production schedules are met.
• Coordinate development and revision of SOPs and change controls.
• Interact with FDA and ensure regulatory compliance and quality assurance involvement.
• Ensure cross-functional collaboration (QA/QC, PPIC, Regulatory) to complete production activities.
• Manage set up of critical new manufacturing processes and equipment.
• Oversee training, staffing, budgeting, and safety audits.

Skills

People management

Leadership

cGMP compliance

Regulatory interaction

SOP development

Problem solving

Cross-functional collaboration

Education

Doctorate degree

Masters degree with 3 years experience in pharma/biotech

Bachelors degree with 5 years experience in pharma/biotech

Associates degree with 10 years experience in pharma/biotech

High School Diploma/GED with 12 years experience in pharma/biotech

Job description

Amgen is seeking a Manager, Manufacturing for a 12-hour PM shift to lead a manufacturing area in an Inspection and Packaging facility. You will manage production, ensure cGMP compliance, hire, train, and develop staff, and coordinate with QA/QC, PPIC, and Regulatory teams to meet schedules.

The role demands strong leadership, regulatory interaction, and ability to optimize processes. The position emphasizes supervising staff, developing SOPs, and maintaining safety standards while aligning with