Pharmaceutical Manufacturing Manager, Weekend AM Simtra BioPharma SolutionsPharmaceutical Manufacturing Manager, Weekend AMBloomington, IndianaThe manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. 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.
Pharmaceutical Manufacturing Manager, Weekend PM Simtra BioPharma SolutionsPharmaceutical Manufacturing Manager, Weekend PMBloomington, IndianaThe manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. 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.
Pharmaceutical Manufacturing Manager, Weekend PM Simtra US LLCPharmaceutical Manufacturing Manager, Weekend PMBloomington, INPhysical / safety requirements: Ability to stand for extended periods of time Physical coordination/flexibility to allow gowning for clean room environments Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection Dexterity and physical condition to perform some level of repetitive motion tasks Ability to wear respirator usage when product or task requires Duties may require overtime work, including nights and weekends Use of hands and fingers to manipulate office equipment is required Must be able to gown qualify for Grade A/B areas (filling) Position may require sitting for long hours. Lean Manufacturing experience required (i.e. value stream mapping, leading kaizen events to drive positive change on the floor, and teaching people to think) Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, MAXIMO, Trackwise, etc.).
Pharmaceutical Manufacturing Manager, Weekend AM Simtra US LLCPharmaceutical Manufacturing Manager, Weekend AMBloomington, INThe manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. 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.
Manufacturing Science and Technology (MSAT) Simtra BioPharma SolutionsManufacturing Science and Technology (MSAT)Bloomington, IndianaIn-depth knowledge of systems and equipment - including scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends. Lead the onboarding and process development activities for the manufacture of new drug products, including the supporting development studies Lead the cross-functional team through technical activities, development studies and PPQ batches.
Manufacturing Group Leader - Maintenance - Bedford GMManufacturing Group Leader - Maintenance - BedfordBedford, IndianaCandidates must possess technical expertise to oversee and support maintenance operations, exercising independent judgment within the framework of Global Manufacturing Systems, with a focus on Safety, People, Quality, Responsiveness, Cost, and Environment (SPQRCE). This includes direct company sponsorship, entry of GM as the immigration employer of record on a government form, and any work authorization requiring a written submission or other immigration support from the company (e.g., H1-B, OPT, STEM OPT, CPT, TN, J-1, etc).
Manufacturing Group Leader - Temporary Summer Help - Bedford GMManufacturing Group Leader - Temporary Summer Help - BedfordBedford, IndianaThis includes direct company sponsorship, entry of GM as the immigration employer of record on a government form, and any work authorization requiring a written submission or other immigration support from the company (e.g., H1-B, OPT, STEM OPT, CPT, TN, J-1, etc). Our vision is a world with Zero Crashes, Zero Emissions and Zero Congestion and we embrace the responsibility to lead the change that will make our world better, safer and more equitable for all.
Manufacturing Group Leader - Production - Bedford General Motors CoManufacturing Group Leader - Production - BedfordBedford, INThe Role: As a Group Leader in Production, Quality, or Global Supply Chain (GSC), you will be responsible for leading teams of employees or technical personnel to drive operational excellence across manufacturing processes. THIS INCLUDES DIRECT COMPANY SPONSORSHIP, ENTRY OF GM AS THE IMMIGRATION EMPLOYER OF RECORD ON A GOVERNMENT FORM, AND ANY WORK AUTHORIZATION REQUIRING A WRITTEN SUBMISSION OR OTHER IMMIGRATION SUPPORT FROM THE COMPANY (e.g., H-1B, OPT, STEM OPT, CPT, TN, J-1, etc.).
Manufacturing Group Leader - Maintenance - Bedford General Motors CoManufacturing Group Leader - Maintenance - BedfordBedford, INCandidates must possess technical expertise to oversee and support maintenance operations, exercising independent judgment within the framework of Global Manufacturing Systems, with a focus on Safety, People, Quality, Responsiveness, Cost, and Environment (SPQRCE). This includes direct company sponsorship, entry of GM as the immigration employer of record on a government form, and any work authorization requiring a written submission or other immigration support from the company (e.g., H1-B, OPT, STEM OPT, CPT, TN, J-1, etc).
Manufacturing Group Leader - Temporary Summer Help General Motors CoManufacturing Group Leader - Temporary Summer HelpBedford, INOur vision is a world with Zero Crashes, Zero Emissions, and Zero Congestion, and we embrace the responsibility to lead the change that will make our world better, safer, and more equitable for all. You will be responsible for coordinating and leading daily team activities to achieve business metrics using GM tools and processes as it relates to material flow.
Manufacturing Group Leader - Temporary Summer Help - Bedford General Motors CoManufacturing Group Leader - Temporary Summer Help - BedfordBedford, IN$53,400–$81,800 / yearThis includes direct company sponsorship, entry of GM as the immigration employer of record on a government form, and any work authorization requiring a written submission or other immigration support from the company (e.g., H1-B, OPT, STEM OPT, CPT, TN, J-1, etc). Our vision is a world with Zero Crashes, Zero Emissions and Zero Congestion and we embrace the responsibility to lead the change that will make our world better, safer and more equitable for all.
Manufacturing Technical Services Representative Simtra BioPharma SolutionsManufacturing Technical Services RepresentativeBloomington, IndianaPartner with Program Management, Quality Assurance Associates, Quality Control Representative, and Manufacturing Representative to coordinate projects, provide support, align facility representation, and provide consistent quality information. 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.
Manufacturing Assembler 2nd shift Cook Medical LLCManufacturing Assembler 2nd shiftEllettsville, INrazor blades, hole punch, and table top grinder • May build product by performing tasks such as cutting, flaring, tipping, sideporting, gluing and bonding • May have to set up and operate various production machines • May use measuring instruments such as calipers and/or micrometers • Count and make simple arithmetic additions and subtractions • Complete quality work at accepted departmental production rates • Constant visual inspection for obvious product non-conformances • May verify raw material • Report quality problems or findings to Management • May have to occasionally use a magnifying device • May work with chemicals such as adhesives, acetone, talcum powder and isopropyl alcohol. • Complete quality work at acceptable department/production determined rates • Ability to work independently or in a team-based setting • Must work and interact effectively and professionally with and for others throughout various levels of the global organization • Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision • Maintain accurate and complete documentation • Read, comprehend and follow product specifications, manufacturing instructions and drawings • May work with small, intricate parts, identifying components with catalog description • May work with various tools/machines, e.g.
Manufacturing Technical Services Representative Simtra US LLCManufacturing Technical Services RepresentativeBloomington, INPartner with Program Management, Quality Assurance Associates, Quality Control Representative, and Manufacturing Representative to coordinate projects, provide support, align facility representation, and provide consistent quality information. 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.
Pharmaceutical Manufacturing Manager, (2nd Shift) Simtra BioPharma SolutionsPharmaceutical Manufacturing Manager, (2nd Shift)Bloomington, IndianaThe manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. 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.
Pharmaceutical Manufacturing Manager, (3rd Shift) Simtra BioPharma SolutionsPharmaceutical Manufacturing Manager, (3rd Shift)Bloomington, IndianaThe manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. 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.
Pharmaceutical Manufacturing Manager, 3rd Shift Simtra US LLCPharmaceutical Manufacturing Manager, 3rd ShiftBloomington, INThe manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. 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.
Manufacturing Operator Cook GroupManufacturing OperatorBloomington, IndianaFrequently required to sit, stand, walk, use hands to grasp, carry, feel or touch; reach with hands and arms; stoop, kneel, crouch; communicate. • High School Diploma, High School Equivalency Diploma or participating in a Cook sponsored program to obtain a High School Diploma or Equivalency Diploma.
Aseptic Filling Group Leader - Weekend PM Simtra US LLCAseptic Filling Group Leader - Weekend PMBloomington, INWith 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. 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.
Filling Group Leader Weekend PM Simtra US LLCFilling Group Leader Weekend PMBloomington, INWith 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. 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.
Principal Manufacturing Science and Technology (MSAT) Representative Simtra BioPharma SolutionsPrincipal Manufacturing Science and Technology (MSAT) RepresentativeBloomington, IndianaRequires in depth knowledge of systems and equipment, including: scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends. The Principal Manufacturing Science and Technology (MSAT) Representative is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Sintra BPS.
Pharmaceutical Manufacturing Operator Simtra BioPharma SolutionsPharmaceutical Manufacturing OperatorBloomington, IndianaProhibited materials in cleanroom areas may include (but are not limited to): food/drink/gum, jewelry, makeup, nail acrylics, perfume/cologne, and personal cell phones . Ability to wear full cleanroom attire (including hairnet, beard cover, shoe covers, gown, gloves, mask, and other PPE) for extended periods .
NewQuality Associate I - Filling (weekend AM) Simtra BioPharma SolutionsQuality Associate I - Filling (weekend AM)Bloomington, IndianaBachelor’s degree (preferred science discipline), or Associate’s degree with at least 1 year of Pharmaceutical Quality, Pharmaceutical Manufacturing or other GXP regulated industry experience, or no degree with at least 2 years Pharmaceutical Quality, Pharmaceutical Manufacturing or other GXP regulated industry experience. 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.
NewQuality Associate I - Filling (weekend PM) Simtra BioPharma SolutionsQuality Associate I - Filling (weekend PM)Bloomington, IndianaBachelor’s degree (preferred science discipline), or Associate’s degree with at least 1 year of Pharmaceutical Quality, Pharmaceutical Manufacturing or other GXP regulated industry experience, or no degree with at least 2 years Pharmaceutical Quality, Pharmaceutical Manufacturing or other GXP regulated industry experience. 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.
Aseptic Equipment Lead Weekend PM Simtra US LLCAseptic Equipment Lead Weekend PMBloomington, INWith 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.
Aseptic Equipment Lead Weekend AM Simtra US LLCAseptic Equipment Lead Weekend AMBloomington, INThe responsibilities: • Become the subject-matter expert for your assigned filling line-whether syringe or vial equipment-and its supporting systems such as component washers, depyrogenation tunnels, filling and stoppering machines, cappers, tray loaders, and lyophilizer loading/unloading systems. 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.
Pharmaceutical Manufacturing Manager, 2nd Shift Simtra US LLCPharmaceutical Manufacturing Manager, 2nd ShiftBloomington, INThe manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. 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.
Aseptic Equipment Lead (Weekend PM) Simtra BioPharma SolutionsAseptic Equipment Lead (Weekend PM)Bloomington, IndianaBecome the subject‑matter expert for your assigned filling line—whether syringe or vial equipment—and its supporting systems such as component washers, depyrogenation tunnels, filling and stoppering machines, cappers, tray loaders, and lyophilizer loading/unloading systems. 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.
Aseptic Equipment Lead (Weekend AM) Simtra BioPharma SolutionsAseptic Equipment Lead (Weekend AM)Bloomington, IndianaBecome the subject‑matter expert for your assigned filling line—whether syringe or vial equipment—and its supporting systems such as component washers, depyrogenation tunnels, filling and stoppering machines, cappers, tray loaders, and lyophilizer loading/unloading systems. 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.
Formulation Group Leader Weekend PM Simtra US LLCFormulation Group Leader Weekend PMBloomington, INWith 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. 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.
Senior Technical Transfer Associate Simtra US LLCSenior Technical Transfer AssociateBloomington, INIn-depth knowledge of systems and equipment - including scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends. Create technical transfer documents supporting this goal [Technical Transfer Plan, Process Development studies (i.e. mixing studies, filtration studies, purge studies, etc.), Demonstration batch records, PPQ master batch record].
Principal Technical Transfer Representative Simtra US LLCPrincipal Technical Transfer RepresentativeBloomington, INRequires in depth knowledge of systems and equipment, including: scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends. The Principal Technical Transfer Representative will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects.