For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

Your role at Simta BioPharma Solutions:

The Quality Lab Associate III performs advanced laboratory testing that requires a variety of chemical, biological, or physical analyses on products in support of the company's quality program. This role works as part of the quality unit. This position reports to a Chemistry Analytical Supervisor.

What you'll do:

• Operates applicable laboratory equipment such as HPLC, UV, Karl Fischer, pH meter, density meter, etc.
• Performs advances biological and chemical assays requiring precise analytical skills and understanding of biology and chemistry principles.
• Performs testing in accordance with applicable Standard Operating Procedures (SOP's).
• Performs testing on raw material lots, in-process products, and finished product batches as required on the associated documentation.
• Maintains data integrity and ensures compliance with company SOP's and worldwide regulatory agency requirements.
• Initiates Laboratory Investigation Reports.
• Uses the US, EU, and Japan pharmacopeias (USP, EP and JP).
• Serves as a mentor and trainer of all QLA personnel.
• Performs transfers of methodology from clients and R&D to the QC Chemistry department.
• Performs reviewing of all testing performed in the QC Chemistry department.
• Participates in internal audits as required.
• Troubleshoot and resolve instrument issues.
• Uses sophisticated laboratory instrumentation and computer systems to collect and record data.
• Works on special projects that involve new methods and instrumentation, including validations studies and development work.
• Perform research and development studies.
• Participate in laboratory software ownership activities.
• Participates in continuous improvement activities that increase efficiency, solve problems, generate cost savings, and improve quality,
• Performs internal laboratory checklist and audits.
• Perform general laboratory/personal area clean-up.

What you'll bring:

• Bachelor's degree in physical science required with a minimum of 10 years pharmaceutical laboratory experience or a Master's degree in a physical science with a minimum of 4 years pharmaceutical laboratory experience.
• Must have been in a QLAII role for at least 4 years to master that skill set.
• Accurate and thorough with attention to detail.
• Work in a courteous and professional manner with interior and exterior clients.
• Strong communication skills, verbal, non-verbal and written, are required.
• Computer proficiency in Microsoft software programs and the ability to learn and use enterprise software.

Physical / Safety Requirements:

• Must be able to wear personal protective equipment.
• Duties may require overtime work, including nights and weekends.
• Use of hands and fingers to manipulate office equipment is required.
• Position may require sitting or standing for long periods of time.
• Must be able to work independently.
• This position requires handling of laboratory chemicals.
• Must be able to qualify for 20/40 corrected vision.

Equal Employment Opportunity

Simtra is 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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Reasonable Accommodations

Simtra is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the and let us know the nature of your request along with your contact information.

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