Manager - New Product Introduction (NPI) and Manufacturing Execution System (MES)

Amgen; Thousand Oaks (CA); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Total Rewards Plan

Job summary

Scorpion Therapeutics seeks a Manager to lead the New Product Introduction and Manufacturing Execution System teams, directing Downstream NPI Specialists and MES Sr. Associates, hiring, training, and performance management.

You will coordinate with PD, DSTE, Supply Chain, Facilities, Quality, and Regulatory to implement new products and electronic batch records, champion Lean OE and drive continuous improvement, with audit readiness.

Qualifications

• Doctorate or Master’s + biotech operations experience
• Bachelor’s + 5 years biotech ops experience or Associate’s + 10 years
• Experience leading teams/projects and resource allocation (may run concurrently)

Responsibilities

• Directly manage Downstream NPI Specialists and MES Sr. Associates, including hiring and performance evaluations
• Proactively assess team capabilities to meet evolving drug substance supply needs
• Lead downstream area team meetings and drive business process alignment
• Coordinate with PD, DSTE, Supply Chain, Planning, Facilities & Engineering, Quality, MES network, and Manufacturing for new products/EBR
• Champion Lean Transformation and OE initiatives; track plant-level progress
• Partner with Regulatory and Quality on change control and audit findings responses
• Drive inspection readiness with updated NPI/MES playbooks and regulatory response strategy

Skills

Leadership

People management

Cross-functional collaboration

Project management

Technical writing

Education

Doctorate

Master’s

Bachelor’s

Associate’s

Tools

PAS X

Werum

Job description

Manager – New Product Introduction (NPI) and Manufacturing Execution System (MES)

Responsibilities:

• Directly manage Downstream NPI Specialists and MES Sr. Associates (NPI/new tech introduction; Electronic Batch Record (EBR) development and management), including hiring, training, oversight, performance evaluations, and development.
• Proactively assess team capabilities to meet evolving drug substance clinical/commercial supply needs.
• Lead downstream area team meetings and drive alignment in business processes.
• Coordinate with PD, DSTE, Supply Chain, Planning, Facilities & Engineering, Quality, MES network, and Manufacturing for new products, new/revised electronic batch records, and/or advanced technologies.
• Champion Lean Transformation/OE initiatives; facilitate continuous improvement and track plant-level progress.
• Partner with Regulatory and Quality on change control compliance and respond to regulatory questions/audit findings.
• Drive inspection readiness by keeping NPI/MES playbooks up to date and supporting audit/regulatory response strategy.

Basic Qualifications:

• Doctorate OR Master’s + 3 years biotech operations OR Bachelor’s + 5 years biotech operations OR Associate’s + 10 years biotech operations.
• Experience managing people and/or leading teams/projects/programs and resource allocation (may run concurrently).

Preferred Qualifications:

• Degree in Chemical Engineering/Industrial Engineering/Biology/Biochemistry.
• Leadership of direct reports.
• PAS X and/or Werum software.
• GMP operations experience (including NPI).
• Drug substance processing technical knowledge (cell culture, harvest, chromatography, filtration, buffer compounding).
• Technical data analysis (trend/forecasting/modeling).
• Communication in presentations and technical writing; coaching/mentoring.
• Lean and operational excellence background.
• Cross-functional project management experience.

Benefits (explicitly stated):

• Total Rewards Plan (eligible health/welfare, retirement savings with company contributions, bonus, stock-based incentives, time-off; flexible work where possible).