Aseptic Manufacturing Manager – Lead & Improve Parenteral Ops

ISPE International; Bloomington (IN); On-site; USD 110,000 - 165,000; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

401(k) Retirement Savings Plan with 1:

Job summary

Simtra BioPharma Solutions is seeking a Manufacturing Manager to lead production on a shift at our Bloomington, IN site, guiding multiple filling lines for sterile injectable products. You will oversee Supervisors, ensure cGMP compliance, and partner with Quality and Technical Services to drive improvements and client deliverables.

The role emphasizes lean leadership, safety culture, and staff development, with responsibilities spanning scheduling, budgeting, and cross-functional collaboration

Qualifications

• Bachelor’s degree in scientific or engineering discipline.
• Minimum 5 years’ experience in aseptic pharmaceutical manufacturing.
• Knowledge of GMPs and worldwide regulatory guidelines.
• Minimum 3 years in a leadership role, preferably in parenteral manufacturing.
• Lean manufacturing experience required (e.g. value stream mapping, kaizen).
• Proficiency with enterprise software (JDE, BPLM, MAXIMO, Trackwise) and MS Office.

Responsibilities

• Lead a team of manufacturing supervisors to meet the production schedule in controlled environments.
• Partner with peers across buildings and shifts to maintain site schedule.
• Hire, coach, and develop staff; set priorities and provide feedback.
• Develop, deploy, and manage processes to run and improve the business.
• Collaborate with Quality and Technical Services to drive investigations and timely closures.
• Approve SOPs, validations, and protocols.
• Support client projects and audits.
• Provide technical resources across departments (Quality, PM, Eng, Maintenance, Tech Services).
• Manage budget and expenses within plan.
• Engage with senior management and client representatives on cross-functional matters.
• Foster a culture of safety and compliance (SISPQ) and lean leadership.

Skills

Leadership

Aseptic manufacturing

GMP knowledge

Lean manufacturing

People development

Regulatory compliance

Education

Bachelor’s degree in science/engineering

Tools

Microsoft Word

Excel

JDE

MAXIMO

Trackwise

Job description

Simtra BioPharma Solutions is seeking a Manufacturing Manager to lead production on a shift at our Bloomington, IN site, guiding multiple filling lines for sterile injectable products. You will oversee Supervisors, ensure cGMP compliance, and partner with Quality and Technical Services to drive improvements and client deliverables.

The role emphasizes lean leadership, safety culture, and staff development, with responsibilities spanning scheduling, budgeting, and cross-functional collaboration