Simtra BioPharma Solutions
Manufacturing Group Lead- Formulation (3rd Shift)
Simtra BioPharma Solutions, Bloomington, Indiana, United States, 47401
Manufacturing Group Lead- Formulation (3rd Shift)
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. Hours for this position are Monday-Thursday 10:00pm-8:30am (4/10hr days) The 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 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. 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 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 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 Physical / safety requirements: 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 Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping Additional requirement(s): High school diploma or GED required 6 months of previous Pharmaceutical or Manufacturing experience preferred. In return, you’ll be eligible for [1] : Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental Life Insurance
Spouse Life Insurance Child Life Insurance
Short and Long-Term Disability Insurance 401(k) Retirement Savings Plan with Company Match Time Off Program
Paid Holidays Paid Time Off Paid Parental Leave and more
Adoption Reimbursement Program Education Assistance Program Employee Assistance Program Community and Volunteer Service Program Employee Ownership Plan Additional Benefits
Voluntary Insurance Benefits
Vision Coverage Accident Critical Illness Hospital Indemnity Insurance Identity Theft Protection Legal and more
Onsite Campus Amenities
Workout Facility Cafeteria Credit Union
[1] Current benefit offerings are in effect through 12/31/25 Disclaimer This 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. 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. Interested in building your career at Simtra BioPharma Solutions? Get future opportunities sent straight to your email. Apply for this job
* indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf What are your annual salary expectations? Are you currently authorized to work in the country you are applying for?* * Select... Will you now or in the future require sponsorship? * Select... Do you have High School Diploma/GED or equivalent? * Select... Where are you currently located? * Please list city and state. Please review the Simtra Privacy Notice and select that you have read and acknowledged the policy using the dropdown box below. * Select... Please list street, APT/Unit #, city, state, and zip code. SMS Consent: Do you agree to receive mobile messages from us in relation to this job application? Message frequency varies. Message and data rates may apply. Reply STOP to opt-out of future messaging. Reply HELP for help. View our Privacy & SMS Policy: * Select... We invite applicants to share their demographic background. If you choose to complete this survey, your responses may be used to identify areas of improvement in our hiring process. How would you describe your gender identity? (mark all that apply) Select... How would you describe your racial/ethnic background? (mark all that apply) Select... How would you describe your sexual orientation? (mark all that apply) Select... Do you identify as transgender? (select one) Select... Do you have a disability or chronic condition (physical, visual, auditory, cognitive, mental, emotional, or other) that substantially limits one or more of your major life activities, including mobility, communication (seeing, hearing, speaking), and learning? (select one) Select... Are you a veteran or active member of the United States Armed Forces? (select one) Select... Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Simtra BioPharma Solutions’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability
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We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury
Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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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. Hours for this position are Monday-Thursday 10:00pm-8:30am (4/10hr days) The 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 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. 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 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 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 Physical / safety requirements: 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 Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping Additional requirement(s): High school diploma or GED required 6 months of previous Pharmaceutical or Manufacturing experience preferred. In return, you’ll be eligible for [1] : Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental Life Insurance
Spouse Life Insurance Child Life Insurance
Short and Long-Term Disability Insurance 401(k) Retirement Savings Plan with Company Match Time Off Program
Paid Holidays Paid Time Off Paid Parental Leave and more
Adoption Reimbursement Program Education Assistance Program Employee Assistance Program Community and Volunteer Service Program Employee Ownership Plan Additional Benefits
Voluntary Insurance Benefits
Vision Coverage Accident Critical Illness Hospital Indemnity Insurance Identity Theft Protection Legal and more
Onsite Campus Amenities
Workout Facility Cafeteria Credit Union
[1] Current benefit offerings are in effect through 12/31/25 Disclaimer This 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. 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. Interested in building your career at Simtra BioPharma Solutions? Get future opportunities sent straight to your email. Apply for this job
* indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf What are your annual salary expectations? Are you currently authorized to work in the country you are applying for?* * Select... Will you now or in the future require sponsorship? * Select... Do you have High School Diploma/GED or equivalent? * Select... Where are you currently located? * Please list city and state. Please review the Simtra Privacy Notice and select that you have read and acknowledged the policy using the dropdown box below. * Select... Please list street, APT/Unit #, city, state, and zip code. SMS Consent: Do you agree to receive mobile messages from us in relation to this job application? Message frequency varies. Message and data rates may apply. Reply STOP to opt-out of future messaging. Reply HELP for help. View our Privacy & SMS Policy: * Select... We invite applicants to share their demographic background. If you choose to complete this survey, your responses may be used to identify areas of improvement in our hiring process. How would you describe your gender identity? (mark all that apply) Select... How would you describe your racial/ethnic background? (mark all that apply) Select... How would you describe your sexual orientation? (mark all that apply) Select... Do you identify as transgender? (select one) Select... Do you have a disability or chronic condition (physical, visual, auditory, cognitive, mental, emotional, or other) that substantially limits one or more of your major life activities, including mobility, communication (seeing, hearing, speaking), and learning? (select one) Select... Are you a veteran or active member of the United States Armed Forces? (select one) Select... Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Simtra BioPharma Solutions’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability
Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury
Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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