Finishing Group Leader (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.

This Role

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.

The Responsibilities

• 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
  
  

Desirable Qualifications

• 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
  
  

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(s)

• 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.
  
  

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

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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