Principal Technical Transfer Representative Job Bloomington area,Indiana USA,Engineering

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 Simtra 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 the development and transfer of new projects.

This position reports to the Sr. Manager, Technical Transfer.

What you'll be doing:

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
Provide technical support to daily Manufacturing operations by being visible on the manufacturing floor, resolving issues during manufacturing and leading process improvement activities
Conduct Non‑Conformance Report (NCR) investigations without assistance, as well as create, own and implement 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 responsibility for advising if product meets release criteria and regulatory requirements
Participate in new project reviews to determine acceptable fit
Review Master Batch Records of junior colleagues and provide guidance
Technical representative in regulatory, client and internal audits as product/process Subject Matter Expert (SME), and ownership of audit responses and related CAPAs
Participate 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
Develop and present in‑depth SME courses on pharmaceutical industry topics
Mentor new hires in Technical Services and help with training and onboarding

What you'll bring:

BS degree required (preferably in a science or engineering related field)
6+ years pharmaceutical manufacturing experience (preferably in a CDMO)
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 (e.g., JDE, BPLM, Mini Tab, Trackwise, etc.)

Physical / Safety Requirements:

Require overtime work on occasion, including nights and weekends
Use of hands and fingers to manipulate office equipment is required
Position requires sitting for long hours, but may involve walking or standing for periods of time
Must be able to qualify for Grade A/B area gowning
Must be able to wear applicable personal protective equipment (PPE)

#LI-SB1

Equal Employment Opportunity

Simtra is 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. EEO is the Law. EEO is the law - Poster Supplement. Pay Transparency Policy.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:

#J-18808-Ljbffr