Biologics NPI Lead: Launch & Process Transfer

Biopharma Careers; Holly Springs (MS); Hybrid; USD 108,000 - 146,000; Full time

Benefits offered by this job

Total Rewards Plan

Remote work arrangements where allowed

Job summary

Amgen is hiring for a Specialist Manufacturing New Product Introduction (NPI): Upstream Readiness. You will interface between GMP manufacturing teams in ANC Biologics DS and Process Development, leading cross-functional meetings to drive tech transfer into the facility.

The role emphasizes NPI ownership, cross-team collaboration, and implementing continuous improvement. Strong project management, communication, and GMP experience are essential.

Qualifications

• Biologics DS manufacturing experience required.
• Strong cross-functional project management and communication skills.
• Experience in GMP manufacturing operations.
• Ability to analyze technical data and drive continuous improvement.

Responsibilities

• Lead NPI coordination with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality, and others to introduce new Drug Substance products.
• Ensure production documents are accurate and up to date; support troubleshooting and RCAs.
• Own NPI Change Controls and drive on-time completion; respond to regulatory questions/audit findings.
• Champion Lean Transformation and OE initiatives to improve productivity and scheduling at the plant.

Skills

Biotech operations

GMP manufacturing

Cross-functional PM

Project management

Communication skills

Lean manufacturing

Operational excellence

Education

Bachelor’s degree in chemistry/biology/engineering

Master’s degree in chemistry/biology/engineering

Doctorate degree

Tools

Chromatography

Filtration

Buffer preparation

Job description

Amgen is hiring for a Specialist Manufacturing New Product Introduction (NPI): Upstream Readiness. You will interface between GMP manufacturing teams in ANC Biologics DS and Process Development, leading cross-functional meetings to drive tech transfer into the facility.

The role emphasizes NPI ownership, cross-team collaboration, and implementing continuous improvement. Strong project management, communication, and GMP experience are essential.