03
Regulatory Intelligence Database
Designed and built a SQL compliance database spanning 61+ countries and 4 IVD products.
Information retrieval 25% faster across EMEA and APAC.
SQLRegulatoryFDA · CE · IVDR
Product · Diagnostics · Sequencing
Ritu Mali
Research Associate — Process Validation Engineering, cobas ePlex
Associate Product Manager — Sequencing, Roche Diagnostics
I take diagnostics products through their lifecycle — validation, launch, on-market care. Now I build them.
Four years inside Roche Diagnostics across validation, quality control, and regulatory affairs. Currently working as an Associate PM in the Sequencing business.
4+ yrs at RocheMSAT → ProductNGS & IVDFDA · CE · IVDR
01About
I work where product meets process — the point where a diagnostic has to be manufacturable, compliant, and worth buying.
Four years at Roche Diagnostics, across validation, quality control, and regulatory. I know how products actually ship, and why they stall.
I think in trade-offs: market demand against cost, speed against traceability. I make the call with data, then align the room.
The problems I like have real constraints — portfolio gaps, launch readiness, products already on the market that need care.
Right now I hold an Associate PM gig in Roche's Sequencing business, about 15 hours a week alongside my full-time MSAT role. The plan is simple: make it full-time.
02Projects
04
Process Analytics at Scale
Statistical process control across 100+ production batches, tied to cost targets and demand forecasting.
Waste down 12%. Process variability down 10%.
SPCData AnalysisCost Reduction
05
ePlex Tower Kit
Coordinated Operations, Commercial, and Supply Chain to land a compliant market strategy.
One aligned plan across three functions, delivered on schedule.
Market StrategyStakeholder Alignment
06
NGS Workflow Optimization
Optimized 3 NGS sample prep workflows, including Oxford Nanopore long-read library preparation.
Statistical analysis of genomic data across two clinical trials.
NGSLibrary PrepR
03Experience
Associate Product Manager
CurrentRoche Diagnostics — Sequencing Business Unit · 2025 — Present · Gig, ~15 hrs/week alongside full-time role
- Co-creating Target Product Profiles with an International PM; prioritizing core requirements from Voice of Customer.
- Benchmarked the sequencing sample prep portfolio against key competitors. Found the gaps — now shaping positioning.
- Building portfolio content for the customer-facing website, guiding customers from browsing to product pages.
Research Associate, Process Validation & MSAT
CurrentRoche Diagnostics (GenMark) · Aug 2024 — Present
- Ran SPC analysis across 100+ production batches. Waste down 12%, variability down 10%.
- Authored and executed IQ/OQ/PQ protocols for 2 new IVD launches, with full 21 CFR Part 820 and ISO 13485 traceability.
- Partnered on the cobas ePlex Demo Consumable launch and the ePlex Tower Kit — Operations, Commercial, and Supply Chain aligned on one market strategy.
- Manage concurrent validation projects prioritized by market demand, aligning R&D, Tech Transfer, Software, Finance, and Manufacturing on deliverables.
- Cut product cost by streamlining process flow against standard manufacturing cost targets.
Quality Control Specialist
GenMark Diagnostics (Roche Group) · Jun 2023 — Aug 2024
- Led pilot testing and validation for two new diagnostic assays and instruments; turned molecular performance data into go/no-go calls for commercial leadership.
- Investigated 25+ non-conformance events, coordinating root cause analysis and CAPA. Wrote the board-ready deviation reports.
- Shipped 7 structured process improvements through iterative testing. Defect rate down 10%.
Regulatory Affairs Associate
GenMark Diagnostics (Roche Group) · Oct 2022 — May 2023
- Built a centralized SQL compliance database across 61+ countries and 4 IVD products. Retrieval 25% faster.
- Maintained registrations and compliance documentation across FDA, CE, and IVDR frameworks in EMEA and APAC.
NGS Library Preparation Intern
Volition America · May 2022 — Aug 2022
- Optimized 3 NGS sample workflows, including Oxford Nanopore long-read prep.
- Analyzed genomic data across two clinical trials and designed the follow-up experiments.
Molecular Biologist
Lifenity Wellness International · Jul 2020 — Jan 2021
- RT-PCR analysis and root cause work across 100+ plasma samples in 2 clinical trials.
- Partnered with Takeda on RT-PCR testing — cut processing time, raised output.
Education
M.S. Biotechnology
California State University, San Marcos · 2023
Al Kern Award for Best Master's Thesis
B.E. Biotechnology
Shivaji University, India · 2020
04Skills
Product
Voice of CustomerTarget Product ProfilesCompetitive BenchmarkingLaunch ReadinessSales EnablementPrioritizationLifecycle ManagementStakeholder Alignment
Data
SQLRSPCGenomic Data AnalysisGoogle Data Analytics (Cert.)
Tools
FMEACAPARoot Cause AnalysisIQ/OQ/PQDeviation ReportsStatistical Methods
Tech
NGS Library PrepOxford NanoporeRT-PCR21 CFR Part 820ISO 13485FDA · CE · IVDR
Languages — English (fluent) · German (A1, learning)
05Contact
Let's talk.
I'm moving into product management full-time. If you're building in diagnostics, sequencing, or anything with real constraints — I'd like to hear about it.
I read every email myself. Expect a reply within a day.