Simtra US LLC
Manufacturing Technical Services Representative
Simtra US LLC, Bloomington, Indiana, United States, 47401
Overview
Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring 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. 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 Manufacturing Technical Services Representative is a member of the core client team and interacts directly with clients. The Manufacturing Technical Services Representative is responsible for technical and process improvement aspects of the project. This position is 100% onsite at the Bloomington facility and reports to the Manager, Manufacturing Technical Services.
Responsibilities
Owner and technical expert of commercial master batch records (MBR) for assigned projects - author, maintain and revise MBRs
Review and release commercial batch records to production for execution
Train manufacturing personnel on new and/or significant changes to MBRs
Investigate Non-Conformance Reports (NCR) and determine root cause to assign/own the corrective action(s)
Authors technical studies in support of investigations or process improvements
Own change controls and associated tasks
Approve project related Bill of Materials
Commercial contact for assigned internal and external clients
Manages client project updates and reviews with all levels of management
Participate (with assistance) in Business Review Meetings
Partner 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
Participate on client calls and on-site visits to discuss projects and issue resolutions
Participate (with assistance) in regulatory, client and internal audits as a product/process Subject Matter Expert (SME) and own the responses for observations
Evaluate non-conformance situations for product impact and advise if the product meets release criteria
Use knowledge of manufacturing systems and equipment to write batch records and perform other duties
Understand the Quality Agreement, Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product
Required qualifications
BS degree, preferably in a science-related field
Familiar with quality operating procedures, quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality
Strong communication skills, both written and verbal, with the ability to interact with many functions and levels across the organization
Strong organizational skills, attention to detail, and collaboration skills with the ability to meet tight deadlines and manage multiple projects concurrently
Intermediate proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
Ability to use enterprise software (i.e., JDE, TrackWise, etc.)
Ability to qualify for Grade C areas
Physical / safety requirements
Duties may require overtime work, including nights and weekends
Position may require sitting or standing for long periods of time
Ability to qualify for Grade C areas
In return, you\'ll be eligible for Current benefit offerings are in effect through 12/31/25
Day One Benefits
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
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
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.
Data Privacy To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/
#J-18808-Ljbffr
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. 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 Manufacturing Technical Services Representative is a member of the core client team and interacts directly with clients. The Manufacturing Technical Services Representative is responsible for technical and process improvement aspects of the project. This position is 100% onsite at the Bloomington facility and reports to the Manager, Manufacturing Technical Services.
Responsibilities
Owner and technical expert of commercial master batch records (MBR) for assigned projects - author, maintain and revise MBRs
Review and release commercial batch records to production for execution
Train manufacturing personnel on new and/or significant changes to MBRs
Investigate Non-Conformance Reports (NCR) and determine root cause to assign/own the corrective action(s)
Authors technical studies in support of investigations or process improvements
Own change controls and associated tasks
Approve project related Bill of Materials
Commercial contact for assigned internal and external clients
Manages client project updates and reviews with all levels of management
Participate (with assistance) in Business Review Meetings
Partner 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
Participate on client calls and on-site visits to discuss projects and issue resolutions
Participate (with assistance) in regulatory, client and internal audits as a product/process Subject Matter Expert (SME) and own the responses for observations
Evaluate non-conformance situations for product impact and advise if the product meets release criteria
Use knowledge of manufacturing systems and equipment to write batch records and perform other duties
Understand the Quality Agreement, Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product
Required qualifications
BS degree, preferably in a science-related field
Familiar with quality operating procedures, quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality
Strong communication skills, both written and verbal, with the ability to interact with many functions and levels across the organization
Strong organizational skills, attention to detail, and collaboration skills with the ability to meet tight deadlines and manage multiple projects concurrently
Intermediate proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
Ability to use enterprise software (i.e., JDE, TrackWise, etc.)
Ability to qualify for Grade C areas
Physical / safety requirements
Duties may require overtime work, including nights and weekends
Position may require sitting or standing for long periods of time
Ability to qualify for Grade C areas
In return, you\'ll be eligible for Current benefit offerings are in effect through 12/31/25
Day One Benefits
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
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
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.
Data Privacy To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/
#J-18808-Ljbffr