Manufacturing Supervisor, Formulation/Preparation (3rd Shift)

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 60,000 - 90,000; Full time

Job summary

Join a forward-thinking company as a Manufacturing Supervisor, where you will play a vital role in ensuring the production of high-quality injectable drug products. This position emphasizes compliance with Good Manufacturing Practices and fosters a collaborative environment focused on safety and quality. You will lead a dedicated team, providing guidance and support while implementing performance measurement programs. With a commitment to continuous improvement, this role offers a unique opportunity to make a significant impact on patient health. If you are passionate about manufacturing excellence and looking to grow your career, this is the perfect chance.

Benefits

Medical & Dental Coverage

401(k) Retirement Savings Plan

Flexible Spending Accounts

Paid Time Off

Education Assistance Program

Employee Ownership Plan

Onsite Workout Facility

Cafeteria

Community and Volunteer Service Program

Life and AD&D Insurance

Qualifications

• Minimum 2 years of manufacturing experience required.
• Minimum 1 year of leadership experience required.
• Ability to follow cGMP and EHS regulations.

Responsibilities

• Supervise daily production and ensure compliance with quality standards.
• Interview, hire, mentor, and develop staff.
• Lead technical reviews and process improvement projects.

Skills

Good Manufacturing Practices

Leadership

Root Cause Analysis

Microsoft Office Suite

Enterprise Software Proficiency

Education

High School Diploma or GED

Bachelor's Degree

Tools

JDE

BPLM

Maximo

Trackwise

Microsoft Dynamics

Job description

Manufacturing Supervisor, Formulation/Preparation (3rd Shift)

Bloomington, Indiana, United States

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. 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 – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including 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.

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence,fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Supervisor, Manufacturing is a member of the Manufacturing Leadership Team and reports directly to the Manufacturing Manager. They provide direct support to Manufacturing personnel and engaged in production of injectable drug products. The Supervisor, Manufacturing provides decision making and oversight to ensure compliance to all standard operating procedures and batch records. They must communicate effectively with manufacturing support departments (Quality, Technical Services, Engineering, etc.), multiple levels of management, and other customer support departments. The Supervisor, Manufacturing builds an environment where partnership, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Its responsibilities:

• Understand and follow current Good Manufacturing Practices
• Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
• Interview, hire, mentor, and develop staff. Conduct annual performance reviews for all direct reports. Assists in setting performance objectives and development plans.
• Supervise the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities – to meet customer requirements including deadlines and quality standards. High percentage of Gemba (shop floor) presence.
• Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals.
• Implement and support training programs designed to enable staff to consistently carry out all manufacturing processes with strict compliance to cGMPs and EHS regulations.
• Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operation efficiency and quality. Implement changes as needed based on assessments.
• 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 and troubleshooting assistance as needed during a deviation in the process; applying Root Cause Analysis (RCA) tools when applicable.
• Obtain qualification to perform select critical operation processes.
• Represent the company during audits and inspections.
• High School diploma or GED required
• Bachelor's Degree strongly preferred
• Minimum 2 years of manufacturing experience required
• Minimum 1 year leadership experience required
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Maximo, Trackwise, Microsoft Dynamics, etc.)

Physical / safety requirements:

• Ability to stand or sit for extended periods of time
• Ability to lift up to 50 pounds
• Ability to push/pull heavy wheeled objects (ie: tanks, carts, pallet jacks, etc.)
• Must be able to perform overhead work (ie: sanitizing walls and ceilings)
• Physical coordination/flexibility to allow gowning for clean room environments
• Use applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
• 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 (corrective lenses acceptable)
• Use of hands and fingers to manipulate office equipment is required
• Must be able to gown qualify for Grade A/B areas (filling)

In return, you’ll be eligible for[1]:

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
  • Spouse Life Insurance
  • Child Life Insurance
• 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
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/25

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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