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 Simtra BioPharma Solutions:

The Microbiology Supervisor leads the daily operations of a Microbiology functional department or quality system. The supervisor serves as the leader of their respective area, and is a critical member of the Microbiology leadership team.

What you'll do:

• Acts as the Supervisor for their respective sub-department.
• Provides guidance, support, direction and leadership to Quality Technicians and Quality Lab Associates through positive interactions with all personnel during daily operations.
• Prioritizes workloads and assigns duties/shift requirements based on company needs.
• Interviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports. Assist in setting performance objectives and development plans.
• Sets local departmental policy and goals, and implement plans and systems to meet those goals.
• Participates in the Microbiology leadership team to build systems and set goals and policy for the Microbiology department.
• Participates in audits and as part of cross-functional teams with other Baxter departments and facilities as the SME (Subject Matter Expert) of the department supervised.
• Writes and reviews investigations for out of level results, and other microbiology related investigations as appropriate.
• Performs statistical analysis of data and evaluates the area supervised for microbiological trends and responds appropriately.

What you'll bring:

• Bachelor's degree in a physical science required, preferably in Microbiology.
• Minimum of 5 years of experience in Quality
• Previous leadership experience preferred.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements:

• Must be able to gown qualify for Grade A/B area.
• The position sometimes requires extended periods of standing.
• Must be able to wear applicable Personal Protective Equipment.
• Position may require handling laboratory chemicals.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required

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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