Develop and execute QC strategy to support clinical product testing and commercial launch.
Lead and provide oversight of analytical method validation and lifecycle management.
Lead complex investigations and champion data integrity principles.
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka is building its core team and is looking for top talent who are passionate about making a difference.
Provide GMP quality oversight for outsourced manufacturing across cell bank, drug substance, drug product, packaging, labeling, and distribution.
Collaborate with cross-functional teams to ensure timely batch disposition, compliant documentation, and proactive quality risk management.
Lead quality record review, manage CDMO relationships, and support regulatory inspections and filings.
Jade Biosciences is a clinical-stage biotechnology company developing best-in-class therapies for autoimmune diseases. As a company launched from Paragon Therapeutics, it is in early clinical and preclinical stages with a focused pipeline.
Provide technical and strategic leadership for late-stage CMC activities.
Work with internal and CDMO CMC teams to ensure timely delivery of PC & PPQ protocols and reports.
Lead CMC meetings and ensure teams are aligned with overall CMC and program strategy.
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. They aim to offer patients suffering from chronic skin diseases the greatest possible freedom from their condition. The company seeks passionate individuals eager to contribute to an engaged, inclusive, and positive company culture.
Perform intermediate-level investigational work in a cGMP/GLP laboratory setting using HPLC, CE-SDS, icIEF, ELISA, and cell-based assays.
Assist in conducting, monitoring, and reporting studies to ensure data accuracy and report quality.
Drive CAPAs and investigations to completion on tight timelines by collaborating across multiple departments.
Eurofins Scientific is an international life sciences company providing analytical testing services across multiple industries. With 58,000 staff in over 900 laboratories across 54 countries, they are the global leader in food, environment, pharmaceutical and cosmetic product testing.
Lead day-to-day oversight of commercial manufacturing operations, process engineering activities, and continuous improvement initiatives.
Drive process optimization, troubleshooting, scale-up, PPQ, validation, and lifecycle management activities for commercial products.
Support regulatory CMC strategy, including development and review of Module 3 CTD submissions and health authority responses.
Deciphera Pharmaceuticals is committed to improve the lives of people with cancer. They offer a dynamic team environment and opportunities for personal and professional growth.
Lead and support all programming activities for clinical studies, including developing Tables, Figures, and Listings (TFLs) using SAS for Clinical Study Reports and regulatory submissions.
Work independently to implement programming strategies, ensure compliance with standards, and contribute to best practices for quality and efficiency.
Communicate and escalate risks, support team activities, and coordinate with biostatisticians to customize outputs for target audiences.
ClinChoice is a global full-service clinical research organization specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 28 years of experience and more than 4,000 professionals across 20+ countries, the company fosters a supportive culture focused on quality, professional development, and low employee turnover.
Lead and oversee clinical monitoring activities for Phase 1–3 global trials.
Establish CRO oversight, manage vendor performance, and ensure compliance with ICH-GCP.
Build scalable monitoring infrastructure, develop SOPs, and drive continuous improvement.
Oruka Therapeutics develops novel biologics for chronic skin diseases like plaque psoriasis. They are an emerging biotech company building a core team with a focus on establishing an engaged, inclusive, and positive culture.
Accountable for all core SP deliverables (SDTM, ADAM, TFLs).
With IT, defines our programming environment and its validation.
Responsible for the development of standards, SOPs, and best practices.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company that appears to be mid-sized, offering a collaborative and fast-paced environment.
Assist in the ongoing development, implementation, and maintenance of the Company’s compliance program.
Develop policies and procedures that provide appropriate guidance and instruction to Company employees.
Lead the development and delivery of compliance training programs for employees at all levels.
Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies. They aim to provide significantly better survival rates with dramatically fewer risks. They have a start-up culture of camaraderie and leadership by example.
Lead batch release activities and provide GMP oversight for manufacturing partners to ensure compliance with global regulations.
Manage investigations, deviations, CAPA, and change controls while supporting audits and inspections.
Mentor and develop junior QA staff and contribute to quality system improvements.
Deciphera is a biopharmaceutical company dedicated to developing innovative therapies for cancer. The company fosters a collaborative culture with opportunities for personal and professional growth.
Author, maintain and implement study-specific Clinical Quality Audit Plan(s) for assigned clinical program(s).
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, they are developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.