Simtra BioPharma Solutions

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support, and secondary packaging.. The Formulation Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.. The Formulation Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.. Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems. Additional Requirement: 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.

group leader

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.
Summary
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 coordinating activities of Formulation Operators who perform in the manufacturing areas. The Formulation Group Leader 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 Formulation Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.


Essential Duties and Responsibilities:
Prepare media and buffer solutions
Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems
Operate general production equipment (such as pH and conductivity meters, autoclaves, portable mixers, 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 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.


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
Basic math skills
Knowledge of aseptic manufacturing practices
Knowledge of standard operating procedures, specifications, and job-specific training materials
Requires the 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
Education and Experience: High school diploma or GED required, 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 (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


Additional Requirement: 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.


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

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