Principal Scientist, MSAT remote Remote, Remote, US . full-time . July 12, 2025 Description **Company Bio** Medexus Pharmaceuticals Inc. is a leading specialty pharmaceutical company with a focus on the therapeutic areas of rheumatology, auto-immune disease, specialty oncology, allergy, and pediatric diseases. We provide market-leading prescription and over-the-counter brands to patients and healthcare professionals, which we believe greatly enhances quality of life and promotes a healthy lifestyle. We have a strong North American commercial platform, and we currently operate through two unique segments: Medexus Pharma Canada and Medexus Pharma USA. Innovation is a driving force for our company. As a result, we are continuously licensing and/or acquiring new products and solutions aimed at addressing the essential needs of consumers, patients, and healthcare partners. **Role Overview** We are seeking a Principal Scientist with deep expertise in upstream biologics process development to join our dynamic and virtual company. In this role, you will serve as a scientific leader in Manufacturing Science and Technology (MSAT), with primary responsibility for mammalian cell culture-based biologics. The ideal candidate will bring a strong understanding of the scientific and operational complexities of a commercial-phase organization as well as experience in a GMP-regulated environment of late-stage development and commercial manufacturing. This position requires deep scientific and technical expertise, exceptional collaboration skills and the ability to drive innovation in a fast-paced, matrixed environment. **Key Responsibilities** + Serve as a scientific and strategic leader in upstream process development for biologics programs, primarily in late-stage clinical and commercial phases + Design, optimize, and scale-up robust mammalian cell culture processes that meet commercial quality and regulatory expectations + Lead process characterization, tech transfer, and contribute to regulatory filings (e.g., IND, BLA) + Develop Design of Experiments (DOE) and analyze complex datasets using statistical tools (e.g., JMP, Excel) + Collaborate closely with external CDMOs, CROs, and vendors to ensure alignment with development goals and GMP compliance + Support technology evaluations and implement innovations to improve process efficiency, robustness, and cost-effectiveness + Drive scientific risk assessment and de-risk commercial processes through deep technical research and cross-functional input + Clearly communicate plans, data, and recommendations to internal teams, senior leadership, external partners, and regulatory agencies + Stay current with industry advancements and evolving regulatory expectations; contribute to the scientific community through presentations and publications **Education, Experience, and Skill Requirements** + Ph.D. in Biochemical Engineering, Biochemistry, Cell Biology, or a related field with 8+ years of industry experience, or BS/MS with 12+ years of experience in biopharmaceutical process development + Demonstrated subject matter expertise in mammalian cell culture process development, scale-up, and optimization + Hands-on experience working in a GMP-regulated environment, particularly in late-stage and commercial-phase biologics manufacturing + Experience leading upstream process development for recombinant biologics + Familiarity with cGMP and clean room manufacturing operations + Strong knowledge of CMC development and regulatory expectations for biologics + Exceptional collaboration skills and experience managing internal and external stakeholders across virtual teams + Proficiency in design of experiments (DOE) and statistical analysis tools (e.g., JMP, MS Office) + Strong working knowledge of FDA, EMA, and ICH guidelines as applied to late-stage and commercial-phase biologics + Familiarity with Drug Substance downstream biologics processing is a plus **Additional Information:** + Compensation range: $150,000- $190,000 + Travel or other requirements: Local travel for this role is anticipated to be 20%, domestic and international travel is expected We recognize that experience comes in many forms. Even if your background or compensation expectations don’t exactly align with all the qualifications or compensation range listed, we encourage you to apply. Your unique skills and experience may be a great fit for this role or other opportunities at Medexus. _Medexus Pharma is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age, disability or any other characteristic protected by law. We assure you that your opportunity for employment with Medexus Pharma depends solely on your qualifications._ Compensation $150,000.00 - $190,000.00 per year