Senior Technical Transfer Associate

Simtra BioPharma Solutions•Bloomington, IN

4d•Onsite

About The Position

The Senior Technical Transfer Associate is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Simtra. This includes designing the process(es) required for the new project. The Tech Transfer Senior Associate 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 to Simtra. This position is 100% onsite at the Bloomington facility and reports to the Sr. Technical Transfer Manager.

Requirements

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.)
Duties will require overtime work on occasion, including nights and weekends
Must be able to qualify for Grade A/B area gowning
Must be able to wear applicable personal protective equipment (PPE)

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