Simtra BioPharma Solutions · 10 hours ago
Senior Technical Transfer Associate (MSAT)
Bloomington, IN
Full-time
Onsite
Senior Level
7+ years expSimtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. The Senior Technical Transfer Associate is responsible for the technical onboarding and process development of new drug product projects, leading cross-functional teams and providing technical support during manufacturing operations.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Lead the onboarding and process development activities for the manufacture of new drug products, including the supporting development studies
Lead the cross-functional team through technical activities, development studies and PPQ batches
Create technical transfer documents supporting this goal [Technical Transfer Plan, Process Development studies (i.e. mixing studies, filtration studies, purge studies, etc.), Demonstration batch records, PPQ master batch record]
Heavy participation/co-lead with Process Validation representative on PPQ strategy and protocol development
Lead during hand-off to the commercial team following PPQ batches
Provides technical support to daily manufacturing operations while being visible on the manufacturing floor and resolving issues during manufacturing
Leads process improvement activities
Independently conduct Non-Conformance Report (NCR) investigations and create, provide ownership, and implementation of Corrective Actions/Preventive Actions (CAPA)
Change Control Management (CCM) owner and impact assessment
Ownership of Fill Volume Dosing Qualification (FVOQ) documentation
Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
Participates in new project reviews to determine acceptable fit
Reviews Master Batch Records of junior colleagues and provides guidance
Independently represents Simtra in regulatory, client and internal audits as product/process Subject Matter Expert (SME). Ownership of audit responses and related CAPAs
Participates independently in client calls and on-site visits to discuss and set strategy for projects and issue resolutions
Standard Operating Procedures (SOP) owner & process subject matter expert (SME)
Perform filter troubleshooting
Develop and present in-depth SME courses on pharmaceutical industry topics
Mentors new hires in Technical Services Department and helps with training and on-boarding
Qualification
Required
BS degree, preferably in a science or engineering related field
7+ years pharmaceutical manufacturing experience
3+ years of applicable Technical Transfer/Process Development experience
In-depth knowledge of systems and equipment - including scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
Expertise in aseptic processing, sterile filtration, and Process Validation
Microsoft Office Suite advanced proficiency Word, Excel, and Outlook
Knowledge and ability to use enterprise software (JDE, BPLM, Minitab, Trackwise, etc.)
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
Onsite Campus Amenities
Workout Facility
Cafeteria
Credit Union
Company
Simtra BioPharma Solutions
Simtra BioPharma Solutions is a pharmaceutical company that manufactures injectables and clinical supplies.
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
2026-01-22
2026-01-20
Company data provided by crunchbase