Principal Technical Transfer Representative

Simtra BioPharma Solutions•Bloomington, IN

24d

About The Position

For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market. Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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. In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies. It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide. The Principal Technical Transfer Representative is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Sintra BPS. This includes designing the manufacturing process(es) required for drug products. The Principal Technical Transfer Representative will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects. This position reports to the Sr. Manager, Technical Transfer.

Requirements

BS degree required (preferably in a science or engineering related field
6+ years pharmaceutical manufacturing experience (preferably in a CDMO)
Requires 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
Experience in aseptic processing, sterile filtration, and process validation
MS Office Suite advanced proficiency
Experience using Enterprise software (i.e., JDE, BPLM, MiniTab, Trackwise, etc.)

Responsibilities

Lead the onboarding and process development activities & tasks for the manufacture of new drug products, including the supporting development studies
Serve as the lead technical expert among a cross functional team
Lead the cross functional team through technical activities, development studies and PPQ batches
Create technical transfer documents supporting this goal [Tech. 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 by being visible on the manufacturing floor, resolves issues during manufacturing and leading process improvement activities
Conduct Non-Conformance Report (NCR) investigations without assistance, as well as creation, ownership and implementation of Corrective Actions/Preventive Actions (CAPA)
Change Control Management (CCM) owner and impact assessment
Ownership of fill volume dosing qualifications (FVOQ)
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
Technical representative in regulatory, client and internal audits as product/process Subject Matter Expert (SME), and 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
SOP owner & process SME
Perform filter troubleshooting
Develops and presents in-depth SME courses on pharmaceutical industry topics
Mentors new hires in Technical Services and helps with training and on-boarding