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Jobs(31,341)/CMO Role(60)/maneuver-marketing (4) - Technical Product Operations Specialist
maneuver-marketing

maneuver-marketing - Technical Product Operations Specialist

Remote - Singapore1mo ago
RemoteSeniorAPACPharmaceuticalsBiotechnologyCMOTechnical Support SpecialistCROD2CReportingClose

Requirements

• A scientific/technical background (food science, chemistry, nutrition, pharma/biotech, or related) • Experience setting production quality standards and managing quality through CMO/CDMO partners — batch records, CAPA, release — rather than an owned site (direct facility auditing a plus) • Able to interpret stability and ingredient testing data (probiotic or botanical a plus), COAs, and QC results critically — you won’t design assays, but you must know what the data means • Hands-on US ingredient/regulatory experience in a regulated consumer category — NDI/GRAS, permitted ingredients, FDA-adjacent compliance (claim wording handled by our consultant) • Experience scoping or managing benefit/claims studies with third-party labs or CROs • Comfortable as the sole technical voice — independent, process-literate in a stage-gate system, and communicating clearly with commercial leaders • Sound, D2C-agile judgement between quality and commercial reality; comfortable with occasional night calls to coincide with US partners • WHAT SUCCESS LOOKS LIKE • CMO standards set up front; batch records pass review with no repeat findings • Stability and testing data ready ahead of every finished-goods release • Claims and labels clear regulatory review with no compliance-driven launch delays • Existing products gain stronger claims evidence over time • Product Innovation and Product Operations have a trusted technical partner in every major decision

Responsibilities

• OWN QUALITY OVERSIGHT AND PRODUCTION TROUBLESHOOTING • Diagnose and resolve production quality problems with our CMO partners, and set production/quality standards before a new product goes into manufacturing • Review production QC, consolidate batch records, close out CAPA, and hold finished-goods release sign-off • Own adverse event reporting (AER); audit CMO facilities when needed • VERIFY PRODUCTS AND RUN STABILITY TESTING • Interpret identity, potency, and probiotic viability results to confirm each product matches its label and holds to end of shelf life • Manage the accelerated and real-time stability program end to end, from protocol review to launch sign-off • GENERATE CLAIMS EVIDENCE • Scope and manage benefit/proof studies on existing products (literature, clinical studies, CRO/IRB) to strengthen what we can say about them • CARRY US INGREDIENT AND REGULATORY REQUIREMENTS • Determine NDI/GRAS/ODI status and confirm permitted ingredients, dosage limits, and market requirements • Maintain ingredient dossiers and scientific substantiation • SUPPORT THE WIDER TEAM • Give technical input on ingredient sourcing, formulation feasibility, and interaction/exposure checks; technically qualify new CMOs, suppliers, and labs • Partner with supply chain on batch-release readiness, give marketing substantiated claims language, and give customer service credible technical answers

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