Manufacturing Supervisor, Weekend PM

Overview

Simtra Bio Pharma Solutions is a world-class contract development and manufacturing organization with facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany. We offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines, all directly injected into patients worldwide.

There is a strong emphasis on quality and continuous improvement, with adherence to high quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra?

We build a culture around five values:
Make it HAPPEN, Make it TOGETHER, Make it RIGHT and Make it COUNT by applying a growth mindset, collaboration, excellence, and patient impact.

The Supervisor, Aseptic Operations is a member of the Operations Leadership Team and reports to the Manager, Aseptic Operations. They lead a team of Operations personnel engaged in the manufacturing of sterile injectable drug products.

The Supervisor provides decision making and oversight to ensure compliance with standard operating procedures and batch records. They communicate effectively with Operations support departments (Quality, Technical Services, Engineering & Maintenance, etc.), multiple levels of management, and other customer support departments. They build an environment where partnership, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Responsibilities

• Understand, follow, coach, and lead teams to execute production activities in accordance with current Good Manufacturing Practices (cGMP).
• Provide guidance, support, direction and leadership through positive interactions during daily operations.
• Interview, hire, mentor, and develop staff. Conduct annual performance reviews for direct reports. Assist in setting performance objectives and development plans.
• Supervise day-to-day production, scheduling, staffing, material management, compliance, training and auditing to meet customer requirements, deadlines and quality standards. High presence on the shop floor (Gemba).
• Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution and in meeting product release time goals.
• Implement and support training programs to ensure manufacturing processes are carried out with strict cGMP and EHS compliance.
• Develop and implement performance measurement and internal auditing programs; evaluate operational efficiency and quality and implement changes as needed.
• Lead technical reviews, investigations and process improvement projects. Provide manufacturing input into integration and validation of new equipment and processes.
• Resolve technical, material and cGMP problems that may impact project deadlines.
• Provide guidance during deviations using Root Cause Analysis (RCA) tools where applicable.
• Obtain qualification to perform select critical operation processes.
• Represent the company during audits and inspections.

Desirable qualifications

• Bachelor's Degree in a science, engineering, or business discipline strongly preferred
• High School diploma or GED required
• Minimum 2 years of manufacturing or operations support experience required
• Minimum 1 year leadership experience required
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (e.g., Microsoft Dynamics, Veeva, Power
  
  BI, Trackwise)

Physical / safety requirements

• Ability to stand or sit for extended periods
• Ability to lift up to 50 pounds
• Ability to push/pull heavy wheeled objects (e.g., tanks, carts, pallet jacks)
• Must be able to perform overhead work (sanitizing walls and ceilings)
• Physical coordination to gown for clean room environments
• Use applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection
• Dexterity and physical condition for repetitive motion tasks
• Ability to wear respirator when required
• Eyesight to inspect equipment and/or filled units (corrective lenses acceptable)
• Must be able to gown qualify for Grade A/B areas (filling)

In return, you ll be eligible for

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance (Spouse/Child)
• Short and Long-Term Disability Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program (Paid Holidays, Paid Time Off, Paid Parental Leave and more)
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Voluntary Insurance Benefits (Vision, Accident, Critical…