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 Prep Group Lead is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor. They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Preparation Operators who perform in the manufacturing areas. The Prep Group Lead provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures. This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments. The Prep Group Lead creates and environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

Essential Duties and Responsibilities:

• Understand and follow current Good Manufacturing Practices
• Assemble and operate filtration systems
• Operate general production equipment (such as autoclaves, vial washers, depyrogenation ovens, scales and balances, etc)
• Monitor and record critical process parameters
• Complete all relevant paperwork following GDP/GMP guidelines
• Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion
• Perform sampling using aseptic techniques
• Participate on Continuous Improvement Teams
• Train and mentor other team members
• Write, revise and review pertinent documentation as appropriate
• Troubleshoot process problems and respond to process alarms
• Assist with process/equipment validation and data analysis
• Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion.
• Required to maintain attendance in accordance with the Bloomington Attendance Policy

• Scheduled weekend overtime will be required

Work Environment: Classified pharmaceutical environment including wearing required gowning as shown in attached document. Occasional work with water and pharmaceutical product while wearing applicable Personal Protective Equipment. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.

Qualification Requirements: To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions:

• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills, including ability to navigate enterprise software (ie Pilgrim, JDE, etc)
• Basic math skills
• Knowledge of aseptic manufacturing practices
• Knowledge of standard operating procedures, specifications, and job-specific training materials
• Requires the operation of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices. Ability to demonstrate proficiency in reading equipment drawings. Ability to work safely with equipment under pressure.

Education and Experience: High school diploma or GED, 6 months of previous Pharmaceutical or Manufacturing experience preferred. 

Language Skills: Must be able to understand, speak, read and write English in order to comply with necessary SOP’, job-specific training materials, GMP’s, and other manuals.

Physical Demands

• Occasional (0-33%)
  • Sitting, climbing stairs and ladders, overhead reaching and/or lifting, balancing, kneeling, crouching, crawling, operating controls
  • Lifting and carrying up to 53 lbs
  • Pushing up to 105 lbs
  • Pulling up to 22 lbs
• Frequent (34-66%)
  • Standing, walking, reaching forward, stooping, object handling, fingering, fine hand coordination simple and firm hand grasping
  • Lifting and carrying up to 34.25 lbs
  • Pushing and pulling up to 15 lbs

Additional Requirement: Final candidates for Prep Group Lead 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.

EEO is the Law EEO is the law - Poster Supplement 
Pay Transparency Policy

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 link here 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:
https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy