Manufacturing Supervisor, Weekend AM

The role

The Supervisor, Aseptic Operations leads a team of Operations personnel in the manufacturing of sterile injectable drug products. They provide decision making and oversight to ensure compliance with standard operating procedures and batch records.

What you will do

• Lead teams to execute production activities in accordance with cGMP
• Provide guidance, support, direction and leadership to personnel
• Interview, hire, mentor, and develop staff
• Conduct annual performance reviews for direct reports
• Supervise day-to-day production, scheduling, staffing, material management, compliance, training and auditing
• Review, approve, and manage documentation for batch and system records
• Implement and support training programs for cGMP and EHS compliance
• Develop and implement performance measurement and internal auditing programs
• Lead technical reviews, investigations and process improvement projects
• Represent the company during audits and inspections

Required qualifications

• High school diploma or GED
• Minimum 1 year of leadership experience
• Proficiency in Microsoft Word, Excel, Outlook, and enterprise systems such as Microsoft Dynamics, Veeva, PowerBI, or TrackWise
• Ability to stand or sit for extended periods of time
• Ability to lift up to 50 pounds
• Ability to push/pull heavy wheeled objects
• Must be able to perform overhead work
• Physical coordination/flexibility to allow gowning for clean room environments
• Use applicable personal protective equipment
• Dexterity and physical condition to perform some level of repetitive motion tasks
• Ability to wear respirator usage when product or task requires
• Eyesight to ensure effective inspection of equipment and/or filled units

Nice to have

• Bachelor’s degree in science, engineering, or business
• Minimum 2 years of manufacturing or operations support experience

Benefits

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave
• Adoption Reimbursement Program

About the company

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market.