Lead integrated program management for R&D, facilities, equipment, and compounding initiatives from concept through validation and operational launch.
Own program plans that span formulation development, process scale-up, facility readiness, equipment installation, qualification (IQ/OQ/PQ), and operational handoff.
Ensure new programs are designed and executed with 503A & 503B sterile and non-sterile operational realities in mind, including capacity, workflows, staffing, and compliance.
Hims & Hers is a health and wellness platform, aiming to help the world feel great through better health. They are redefining healthcare by prioritizing the customer and delivering affordable, accessible, and personal care.
Management of commercial API CMOs and RSM suppliers from raw material ordering oversight to manufacturing and release of API, in collaboration with various CMC functions.
Leads or supports documentation review and approval (MBRs, specs, methods), change controls and documentation for batch disposition.
Identifies and leads key process problem resolution activities and process improvement initiatives, and resolves issues.
BridgeBio is dedicated to discovering, developing, and delivering transformative medicines for patients living with genetic diseases and genetically defined cancers. It is a global biotechnology company with headquarters in San Francisco and Zug, building empowered, high-performing teams.
Support operational planning, start-up, execution, and close-out activities for Phase 3 clinical studies in HCM.
Oversee CROs, vendors, clinical sites, and external partners to ensure delivery of high-quality data, adherence to timelines, and compliance with GCP and regulatory requirements.
Lead selection, onboarding, and oversight of CROs, central labs, imaging vendors, and specialty service providers.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease.
Oversee the drug substance, drug product, reference standard, and packaging/labeling/serialization contract service providers for clinical-phase and commercial production activities.
Review and approve key strategic product / process documents (i.e. specifications, batch records, tech transfer/validation protocols, etc.).
Lead, review and approve change controls, deviations, temperature excursions, investigations, OOX, CAPA, and Product Quality Complaints.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business and are exemplified by each and every one of their team members.
Lead the development, formulation, and production of better-for-you candy products.
Collaborate with flavor houses, ingredient suppliers, and contract manufacturers to bring products from concept to launch.
Translate brand product briefs into commercially viable formulations that meet nutritional and sensory standards.
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