Lead drug product CMC strategy for small molecule programs from early to late stage.
Oversee formulation, process development, scale-up, technology transfer, and validation.
Manage CDMOs and external partners to ensure quality, timelines, and supply continuity.
Our partner is a biotechnology company focused on advancing small molecule drug product development. They operate in a fast-moving, highly outsourced environment with a collaborative, patient-focused culture.
Manage analytical development, QC, and stability activities at contract manufacturing sites.
Author and review CMC sections for US and ex-US regulatory filings.
Collaborate with Quality Assurance to close investigations and manage change controls.
BridgeBio is a biotech company that pioneered a 'moneyball for biotech' approach, pooling projects and early-stage research to reduce risk and develop medicines for rare diseases. They foster a culture of curiosity and experimentation with small teams of experts.
Lead cross-site technology transfer, cleaning validation, and process validation for sterile and nonsterile manufacturing operations.
Serve as the go-to technical resource for diagnosing and resolving process deviations, yield losses, and quality issues across four sites.
Manage and develop site Technical Services Managers, setting network-wide standards and ensuring consistency in validation and troubleshooting.
Hims & Hers is a leading health and wellness platform that redefines healthcare by providing affordable, accessible, and personal care from diagnosis to treatment to delivery. As a publicly traded company on the NYSE, it fosters a culture of innovation, normalizing health challenges, and supports a talent-first flexible/remote work approach.
Achieve assigned Bioproduction sales targets and provide sales support to account managers and distributor partners.
Identify new opportunities at strategic accounts and non-strategic accounts with potential for over $1M in revenue.
Train distributor partners, maintain CRM data, and communicate customer feedback to internal teams.
FUJIFILM Biosciences provides cell culture media, discovery research reagents, and critical assay materials to biotech and pharma partners. Part of Fujifilm, a global company with over 70,000 employees, the culture fosters curiosity, collaboration, and innovation.
Support GMP CMC operations including review of batch records, analytical data, and product release for clinical-use drug substances and products.
Manage quality oversight for GMP vendors, audits, and quality agreements, and act as a QA point of contact for internal and external partners.
Review and approve quality events such as OOS, deviations, CAPAs, and change controls to ensure regulatory compliance.
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for patients with cancer, targeting the RAS/MAPK pathway. With a small, collaborative team and a casual, mission-driven culture, they are committed to erasing cancer.
Execute analytical strategies for commercial products, ensuring compliance and method lifecycle management.
Lead method transfer, validation, and investigations at CDMOs, supporting regulatory submissions.
Serve as analytical SME, partnering cross-functionally to ensure quality and supply continuity.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. The company fosters a culture of trust, ownership, curiosity, and results with a collaborative team.
Oversee quality compliance for combination products, ensuring regulatory standards and company objectives are met.
Develop and implement quality strategies in collaboration with cross-functional teams and external partners.
Stay current with global device and combination product regulations, supporting audits and design control oversight.
Vera Therapeutics is a commercial-stage biotechnology company focused on transforming medicine in autoimmune disease, starting with the kidney. Founded in 2016 and based in Brisbane, California, the company fosters a culture of empathy, urgency, and an owner's mindset.
Lead clean utilities engineering initiatives across design, construction, commissioning, and startup for large-scale cGMP facility projects.
Serve as technical owner for high-purity water, clean steam, and process gas systems, developing specifications and supporting qualification activities.
Collaborate with cross-functional teams to improve quality, sustainability, productivity, and cost efficiency in pharmaceutical and life sciences environments.
This company provides engineering services for pharmaceutical and life sciences facilities, focusing on clean utility systems and large-scale project support. The team is collaborative and people-focused, offering opportunities to work on high-impact projects with multidisciplinary technical teams.
Serve as the primary Clinical QA point of contact for a Phase 3, global study.
Collaborate with cross-functional groups to support study start-up and execution.
Perform clinical site audits and support inspection readiness.
Priovant is a biopharmaceutical company committed to developing therapies for autoimmune diseases. They have a small, collaborative team with a hands-on culture.
Lead extraction and formulation strategy, driving innovation and operational excellence across multi-site facilities.
Oversee compliance with federal, state, and local regulations, maintaining high safety standards.
Build and mentor a high-performing team, fostering a culture of collaboration and continuous improvement.
Green Thumb is a cannabis company that produces and sells cannabis and hemp extracts in Vape, Concentrates, and Edibles categories. It is a multi-state operation with a focus on innovation and quality, fostering a collaborative culture.