Simtra BioPharma Solutions · 1 month ago
Manufacturing Technical Services Representative
Bloomington, Indiana, United States
Full-time
Onsite
Mid LevelSimtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies. The Manufacturing Technical Services Representative will be responsible for technical and process improvement aspects of projects, interacting directly with clients and ensuring quality compliance throughout the manufacturing process.
BiopharmaManufacturingMedicalPharmaceutical
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 Report (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
Evaluates non-conformance situations for product impact and responsible for advising if product meets release criteria
Use knowledge of manufacturing systems and equipment to write batch record and perform other duties
Understands the Quality Agreement, Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product
Qualification
Required
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
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
Voluntary Insurance Benefits
Vision Coverage
Accident
Critical Illness
Hospital Indemnity Insurance
Identity Theft Protection
Legal and more
Workout Facility
Cafeteria
Credit Union
Company
Simtra BioPharma Solutions
Simtra BioPharma Solutions is a pharmaceutical company that manufactures injectables and clinical supplies.
Founded in 1930
1001-5000 employees
H1B Sponsorship
Simtra BioPharma Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
Funding
Current Stage
Late StageTotal Funding
$0.5M2024-12-19Grant· $0.5M
Leadership Team
M
Mike Schaefers
Chief Commercial Officer (CCO) & Head of Business Development
Recent News
Inside INdiana Business
2025-09-23
Company data provided by crunchbase