Formulation Group Leader Weekend PM

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 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.Weekend PM Schedule: Friday-Sunday 7:00pm-7:30amThe responsibilities:Prepare media and buffer solutionsOperate Clean-in-Place (CIP) and Steam-in-Place (SIP) systemsOperate general production equipment (such as pH and conductivity meters, autoclaves, portable mixers, scales and balances, etc)Monitor and record critical process parametersComplete all relevant paperwork following GDP/GMP guidelinesPerform routine maintenance and cleaning of production equipment to maintain in GMP fashionPerform sampling using aseptic techniquesParticipate on Continuous Improvement TeamsTrain and mentor other team membersWrite, revise and review pertinent documentation as appropriateTroubleshoot process problems and respond to process alarmsAssist with process/equipment validation and data analysisWork with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completionRequired to maintain attendance in accordance with the Bloomington Attendance PolicyScheduled weekend overtime will be requiredWork 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.Desirable qualifications:RequirementsTo 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 independentlyGood communication skillsGood documentation skills, including legible handwritingGood interpersonal skillsBasic computer skillsBasic math skillsKnowledge of aseptic manufacturing practicesKnowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter ExpertRequires 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 devicesPhysical / safety requirements:Occasional (1-33%)Sitting, climbing stairs and ladders, balancing, kneeling, operating controlsFrequent (34-66%)Standing, walking, reaching forward and overhead, stooping, crouching,Pushing and pulling up to 110 lbsLifting and carrying up to 70 lbsConstant (67-100%)Object handling, fingering, fine hand coordination, simple hand grasping, firm hand graspingAdditional requirement(s):High school diploma or GED required6 months of previous Pharmaceutical or Manufacturing experience preferred.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.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.In return, you’ll be eligible for[1]: Day One BenefitsMedical & Dental CoverageFlexible Spending AccountsLife and AD&D InsuranceSupplemental Life InsuranceSpouse Life InsuranceChild Life Insurance401(k) Retirement Savings Plan with Company MatchTime Off ProgramPaid HolidaysPaid Time OffPaid Parental Leave and moreAdoption Reimbursement ProgramEducation Assistance ProgramEmployee Assistance ProgramCommunity and Volunteer Service ProgramEmployee Ownership PlanAdditional BenefitsShort and Long-Term Disability InsuranceVoluntary Insurance BenefitsVision CoverageAccidentCritical IllnessHospital Indemnity InsuranceIdentity Theft ProtectionLegal and moreOnsite Campus AmenitiesWorkout FacilityCafeteriaCredit Union[1] Current benefit offerings are in effect through 12/31/26DisclaimerThis 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 OpportunitySimtra 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.Data PrivacyTo learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Privacy Policy:Privacy Policy — Simtra BioPharma Solution