Lead end-to-end drug substance process development and manufacturing for small molecule APIs from route assessment through commercialization.
Serve as primary technical interface with CDMOs, ensuring supply continuity and regulatory readiness.
Author and defend drug substance CMC sections for regulatory submissions and represent CMC in agency interactions.
Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. A well-funded startup with teams of scientists, veterinarians, engineers, operations, and creatives, we're committed to earning FDA approval for the first lifespan extension medicine for any species.
Provides quality oversight of QC laboratory activities, ensuring compliance with global GxP regulations across multiple indications.
Manages GMP testing at CMOs and contract testing laboratories, including raw data review and exceptions management.
Collaborates with CMC Manufacturing, Quality Assurance, and Regulatory Affairs to align testing timelines with corporate goals.
Immunovant is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. They are a publicly traded, clinical-stage biopharmaceutical company with a dynamic, fast-paced, entrepreneurial culture.
Provide strategic and technical leadership for CMC activities, overseeing technology transfer, scale-up, and cGMP manufacturing for small molecule drug development.
Manage contract manufacturing organizations and author regulatory submission sections to ensure alignment and timely achievement of program milestones.
Collaborate cross-functionally with Quality, Regulatory Affairs, and Supply Chain to support clinical and commercial goals from Phase I through commercialization.
Travere Therapeutics is a biopharmaceutical company dedicated to identifying, developing, and delivering life-changing therapies for people living with rare disease. The company is a dedicated team focused on meeting the unique needs of rare patients, fostering a collaborative, diverse, and fast-paced environment centered on patients, courage, community, and collaboration.
Provide advisory on clinical development analytics, leveraging 10+ years of pharma experience.
Lead adoption of data tools and dashboards across clinical development teams.
Translate between data engineering and clinical stakeholders to optimize drug development data.
Edison Scientific is a biotech and pharma analytics firm focused on clinical development data. They offer a mission-driven culture with regular team offsites and a fast-moving environment.
Manage accounts in assigned area, present LGC Standards products to new and existing customers, and identify and close prospect opportunities.
Collaborate with LGC's sales resources, use sales tools to prospect and nurture opportunities, and meet sales targets.
Work with marketing to launch new products, handle territory planning, and manage pricing strategies.
LGC Standards is a division of LGC Group, the UK's designated National Measurement Institute, providing reference materials and quality assurance tools. They serve analytical needs in over 120 countries and employ a team dedicated to science for a safer world.