Manufacturing Senior Supervisor, Formulation/Preparation (2nd Shift)

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.

 

Why join Team Simtra? Because we:

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.

 

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The role:

The Senior 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 Senior 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 Senior 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.
• Author Non-conformance investigation reports (NCRs).

 

Desirable qualifications:

• HS Diploma/GED required, Bachelor’s degree preferred
• Minimum 3 years of manufacturing experience required
• Minimum 4 years leadership related experience required
• In-depth knowledge of related pharmaceutical manufacturing equipment and processes preferred
• Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry preferred
• 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]:

• Day One Benefits
  • 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
• 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 12/31/24

 

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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.

 

Equal Employment Opportunity

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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