Simtra BioPharma Solutions
Finishing Group Leader (2nd Shift)
Simtra BioPharma Solutions, Bloomington, Indiana, United States, 47401
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 Finishing Production Group Leader provides leadership, coaching and communication on an individual and group basis to meet client demand and expectations. The Group Leader contributes to creating an environment where teamwork, productivity, Safety, Identity, Strength, Purity and Quality (SISPQ) are reflected in the finished product. This position reports to a Manufacturing Supervisor.
The responsibilities:
Production Operations Monitoring & ExecutionCommunicate process/equipment delays to appropriate levels of management as well as subsequent shiftsWork with Sr. Technicians to improve line performance (uptime and efficiency)Manage TOR (Time out of refrigeration) for refrigerated productCoordinate material delivery and pick-up with Warehouse and Label Control personnelManage electronic inventory transactions at the time of activity completionCoordinate with Technical Services and Engineering to process Technical and Qualification studies, respectivelyMonitor and ensure batch record requirements and applicable SOPs are being followed properlySet-up for next shift operationsEncourage and promote good safety practicesParticipate and lead Continuous Improvement and TrainingDesirable qualifications:
High school diploma or GED requiredMinimum 2 years related experience preferredTeam OrientedProblem identification and solvingGood communication skillsGood documentation skills, including legible handwritingBasic computer and math skillsAbility to understand and follow standard operating procedures, specifications, and job-specific training materialsAbility to understand, speak, read and write EnglishPhysical / safety requirements:
Must be able to meet 20/20 corrected vision requirement and pass color blind testMust be able to lift, push/pull, and carry up to 30 poundsRequired to stand for over 4 hours per day, including constant standing for 2 hours at a timeDuties may require overtime work, including weekendsUse of hands and fingers to manipulate equipment is requiredAdditional requirement(s):
Final candidates for Finishing 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.In return, you'll be eligible for [1] :
Day One Benefits
Medical & Dental CoverageFlexible Spending AccountsLife and AD&D InsuranceSupplemental Life Insurance
Spouse Life InsuranceChild Life Insurance
Short and Long-Term Disability Insurance401(k) Retirement Savings Plan with Company MatchTime Off Program
Paid HolidaysPaid Time OffPaid Parental Leave and more
Adoption Reimbursement ProgramEducation Assistance ProgramEmployee Assistance ProgramCommunity and Volunteer Service Program
Additional Benefits
Voluntary Insurance Benefits
Vision CoverageAccidentCritical IllnessHospital Indemnity InsuranceIdentity Theft ProtectionLegal and more
Onsite Campus Amenities
Workout FacilityCafeteriaCredit Union
[1] Current benefit offerings are in effect through 12/31/24
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.
Equal Employment Opportunity
Simtra is proud to be 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 LawEEO is the law - Poster SupplementPay Transparency Policy
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
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 Finishing Production Group Leader provides leadership, coaching and communication on an individual and group basis to meet client demand and expectations. The Group Leader contributes to creating an environment where teamwork, productivity, Safety, Identity, Strength, Purity and Quality (SISPQ) are reflected in the finished product. This position reports to a Manufacturing Supervisor.
The responsibilities:
Production Operations Monitoring & ExecutionCommunicate process/equipment delays to appropriate levels of management as well as subsequent shiftsWork with Sr. Technicians to improve line performance (uptime and efficiency)Manage TOR (Time out of refrigeration) for refrigerated productCoordinate material delivery and pick-up with Warehouse and Label Control personnelManage electronic inventory transactions at the time of activity completionCoordinate with Technical Services and Engineering to process Technical and Qualification studies, respectivelyMonitor and ensure batch record requirements and applicable SOPs are being followed properlySet-up for next shift operationsEncourage and promote good safety practicesParticipate and lead Continuous Improvement and TrainingDesirable qualifications:
High school diploma or GED requiredMinimum 2 years related experience preferredTeam OrientedProblem identification and solvingGood communication skillsGood documentation skills, including legible handwritingBasic computer and math skillsAbility to understand and follow standard operating procedures, specifications, and job-specific training materialsAbility to understand, speak, read and write EnglishPhysical / safety requirements:
Must be able to meet 20/20 corrected vision requirement and pass color blind testMust be able to lift, push/pull, and carry up to 30 poundsRequired to stand for over 4 hours per day, including constant standing for 2 hours at a timeDuties may require overtime work, including weekendsUse of hands and fingers to manipulate equipment is requiredAdditional requirement(s):
Final candidates for Finishing 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.In return, you'll be eligible for [1] :
Day One Benefits
Medical & Dental CoverageFlexible Spending AccountsLife and AD&D InsuranceSupplemental Life Insurance
Spouse Life InsuranceChild Life Insurance
Short and Long-Term Disability Insurance401(k) Retirement Savings Plan with Company MatchTime Off Program
Paid HolidaysPaid Time OffPaid Parental Leave and more
Adoption Reimbursement ProgramEducation Assistance ProgramEmployee Assistance ProgramCommunity and Volunteer Service Program
Additional Benefits
Voluntary Insurance Benefits
Vision CoverageAccidentCritical IllnessHospital Indemnity InsuranceIdentity Theft ProtectionLegal and more
Onsite Campus Amenities
Workout FacilityCafeteriaCredit Union
[1] Current benefit offerings are in effect through 12/31/24
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.
Equal Employment Opportunity
Simtra is proud to be 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 LawEEO is the law - Poster SupplementPay Transparency Policy
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