MSAT Senior Associate (Tech Transfer)

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 clinical and/or 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, GMP clinical/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. The position is visible on the Manufacturing floor, resolves issues during manufacturing and leads process improvement activities.
• Conduct deviation (DEV) 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.
• Grade A/B gowning qualification. Will enter Grade B areas for Batch support.
• 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.
• SOP owner & process SME.
• Trains and will perform filter troubleshooting.
• Develops and presents in-depth SME courses on pharmaceutical industry topics.
• Mentors new hires in MSAT/Technical Services and helps with training and on-boarding.

Requirements

• Bachelor’s degree required, preferably in a science or engineering related field.
• 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.
• In-depth expertise in aseptic processing, sterile filtration, and clinical manufacturing and/or Process Validation.
• Five (5) years pharmaceutical manufacturing experience, with a minimum of 3 years of applicable MSAT/Tech Transfer/Process Development experience.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, MiniTab, Trackwise, etc.).