Program Lead/Sterility Assurance Review Senior Consultant

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.

With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Location: Kansas City, KS (onsite) Duration: 2-3 months Scope: Position will act as the overall lead for the retrospective product review workstream.

Responsible for development of the review methodology, technical oversight of lot assessments, product impact evaluations, client communication, and final report review and approval. Duties include: Lead the sterility review team (2-3 people) Serve as the primary client point of contact and overall workstream lead. Develop and finalize the review protocol and assessment methodology. Coordinate execution of the retrospective review and associated deliverables. Provide technical oversight of the review process. Perform secondary review of lot assessments and product impact assessments.

Review technical conclusions for consistency and scientific rationale. Facilitate escalation of significant product-quality concerns. Support preparation and finalization of interim reports and final deliverables. Participate in project governance meetings and status updates. Years of Experience: 10 years Key Experience Required: Sterile manufacturing, sterility assurance, product impact assessments, aseptic processing, FDA remediation #LI-JH1 #LI-HYBRID We celebrate our differences and strive to create a workplace where each person can be their authentic self.

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• Minimum 10 years’ experience in sterile manufacturing, sterility assurance, aseptic processing, and FDA remediation
• Proven ability to lead teams and manage client communications as primary point of contact
• Expertise in developing review protocols, conducting product impact assessments, and overseeing technical evaluations