Simtra BioPharma Solutions
Healthcare
FormulationGroupLeader,3rdShift
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Formulation Group Leader, 3rd Shift at Simtra BioPharma Solutions. Skills: Formulation, Manufacturing Leadership, Quality Assurance, Regulatory Compliance, Team Management. Provide direct support to manufacturing to ensure that finished products meet the required specifications. Coordinate activities of Formulation Operators”
What You'll Achieve.
Ensure that finished products meet the required specifications; Ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures; Create an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product; Improve patient health
Industry & Context.
Troubleshoot process problems; Respond to process alarms; Assist with process/equipment validation and data analysis
Classified pharmaceutical environment wearing required gowning, Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions, Must be able to occasionally (1-33% of the time) work in a confined/clustered work space, Occasional (1-33%) Sitting, climbing stairs and ladders, balancing, kneeling, operating controls, Frequent (34-66%) Standing, walking, reaching forward and overhead, stooping, crouching, Pushing and pulling up to 110 lbs, Lifting and carrying up to 70 lbs, Constant (67-100%) Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping, Final candidates for Formulation 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, Scheduled weekend overtime will be required
What They're Looking For.
Must Have
Ability to work independently, Good communication skills, Good documentation skills, including legible handwriting, Good interpersonal skills, Basic computer skills, Basic math skills, Knowledge of aseptic manufacturing practices, Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert, Operations 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, Must be able to understand, speak, read and write English
Nice to Have
6 months of previous Pharmaceutical or Manufacturing experience
What You'll Do.
Provide direct support to manufacturing to ensure that finished products meet the required specifications
Coordinate activities of Formulation Operators
Provide decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures
Fully support and drive quality operations on the production floor
Communicate effectively with production team members
multiple levels of management
and other customer support departments
Create an environment where teamwork
and quality (SISPQ) are reflected in the finished product
Prepare media and buffer solutions
Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems
Operate general production equipment
Monitor and record critical process parameters
Complete all relevant paperwork following GDP/GMP guidelines
Perform routine maintenance and cleaning of production equipment
Perform sampling using aseptic techniques
Participate on Continuous Improvement Teams
Train and mentor other team members
revise and review pertinent documentation
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
Maintain attendance in accordance with the Bloomington Attendance Policy
Scheduled weekend overtime will be required
How You'll Work.
Team & Collaboration
Work as one, respecting each voice and tapping into unique strengths across teams; Communicate effectively with production team members, multiple levels of management, and other customer support departments; Work with other groups such as maintenance/metrology and calibration
Communication Scope
Good communication skills; Communicate effectively with production team members, multiple levels of management, and other customer support departments; Must be able to understand, speak, read and write English
Process & Methodology
Participate on Continuous Improvement Teams
Full Job Description
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 Formulation Group Leader 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 coordina
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