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.

The Finishing Production Group Leader provides leadership, coaching and communication on an individual and group basis to meet client demand and expectations. The Group Leader contributes to creating an environment where teamwork, productivity, Safety, Identity, Strength, Purity and Quality (SISPQ) are reflected in the finished product. This position reports to a Manufacturing Supervisor.

What You'll Be Doing

• Production Operations Monitoring & Execution
• Communicate process/equipment delays to appropriate levels of management as well as subsequent shifts
• Work with Sr. Technicians to improve line performance (uptime and efficiency)
• Manage TOR (Time out of refrigeration) for refrigerated product
• Coordinate material delivery and pick-up with Warehouse and Label Control personnel
• Manage electronic inventory transactions at the time of activity completion
• Coordinate with Technical Services and Engineering to process Technical and Qualification studies, respectively
• Monitor and ensure batch record requirements and applicable SOPs are being followed properly
• Set-up for next shift operations
• Encourage and promote good safety practices;
• Participate and lead Continuous Improvement and Training,

What You'll Bring

• High school diploma or GED required
• Minimum 2 years related experience preferred
• Team Oriented
• Problem identification and solving
• Good communication skills
• Good documentation skills, including legible handwriting
• Basic computer and math skills
• Ability to understand and follow standard operating procedures, specifications, and job-specific training materials
• Ability to understand, speak, read and write English

This role is eligible for a $1000 Sign On Bonus to new hires who have not worked previously with Simtra BioPharma Solutions within the last 12 months.

Physical / Safety Requirements

• Must be able to meet 20/20 corrected vision requirement and pass color blind test
• Must be able to lift, push/pull, and carry up to 30 pounds
• Required to stand for over 4 hours per day, including constant standing for 2 hours at a time
• Duties may require overtime work, including weekends
• Use of hands and fingers to manipulate equipment is required

Additional Requirement: Final candidates for Finishing Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:We are an equal opportunity employer. We evaluate 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.