Aseptic Pharma Manufacturing Manager (3rd Shift)

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 1:

Paid Holidays

Paid Time Off

Parental Leave

Job summary

Simtra BioPharma Solutions in Bloomington, IN, is seeking a Pharmaceutical Manufacturing Manager (3rd Shift) to oversee all production activities on a shift for multiple injectable lines. You will lead Manufacturing Supervisors, ensure cGMP compliance, drive process improvements, and work with Cross-functional teams to meet client delivery dates.

The role requires 5+ years in aseptic pharma manufacturing, 3+ years in a leadership role, and Lean Manufacturing experience.

Qualifications

• Bachelor’s degree strongly preferred, with emphasis on a scientific or engineering discipline.
• Minimum 5 years’ experience in all aspects of the aseptic pharmaceutical manufacturing process.
• Minimum 3 years in a leadership role, preferably in parenteral manufacturing.
• Lean Manufacturing experience required (i.e. value stream mapping, leading kaizen events).
• Knowledge of GMPs and worldwide regulatory agency guidelines.
• Proficiency in Microsoft Word, Excel, and Outlook; ability to use enterprise software (examples include JDE, BPLM, MAXIMO, Trackwise).

Responsibilities

• Lead a team of manufacturing supervisors to compliantly meet the production schedule in controlled environments.
• Partners with peers in other manufacturing buildings and on other shifts to ensure the site schedule is maintained.
• Interviews, hires, coaches, and develops staff with feedback and clear direction.
• Develop, deploy, and manage processes to run and improve the business.
• Coordinate with Quality, Program Management, Engineering, Maintenance and Technical Services to support projects and investigations.
• Ensure SOPs, validations, and protocols are approved timely.
• Ensure budget adherence and manage expenses within plan.
• Collaborate with client teams for projects and audits.
• Promote safety and a culture of quality (SISPQ) on the floor.

Skills

Lean Manufacturing

Leadership

GMP knowledge

Education

B.S. in science or engineering

Tools

JDE

BPLM

MAXIMO

Trackwise

Job description

Simtra BioPharma Solutions in Bloomington, IN, is seeking a Pharmaceutical Manufacturing Manager (3rd Shift) to oversee all production activities on a shift for multiple injectable lines. You will lead Manufacturing Supervisors, ensure cGMP compliance, drive process improvements, and work with Cross-functional teams to meet client delivery dates.

The role requires 5+ years in aseptic pharma manufacturing, 3+ years in a leadership role, and Lean Manufacturing experience.