Senior or Principal Scientist, Formulation and Process Development

🕒 September 23

🇺🇸 United States – Remote

💵 $150k - $175k / year

⏰ Full Time

🟠 Senior

🧬 Research Scientist

👻 Ghost score 2%

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Celcuity

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor being evaluated in breast and prostate cancer trials. The company advances a focused pipeline aimed at delivering transformative, targeted cancer treatments and conducts clinical development and data-driven research to support regulatory and medical adoption.

📋 Description

• Lead formulation and process development projects across the product lifecycle • Support pre-formulation, dosage form selection, formulation development, process development, and manufacturing scale-up • Design, execute, and interpret experiments in outsourced environments at contract laboratories and CDMOs • Identify and vet contract organizations for formulation and process development • Define and execute project plans for formulation lifecycle management • Support technical sections for intellectual property and regulatory filings • Maintain knowledge of formulation development trends, techniques, and technologies • Serve as a formulation development subject matter expert for Pharmaceutical Development and Celcuity • Summarize, document, and present information to subgroup, group, and cross-functional audiences • Perform other duties as assigned

🎯 Requirements

• Ph.D., M.S., or B.S. in Pharmaceutical Science, Chemical Engineering, Chemistry, Biochemistry, Biochemical Engineering, or related fields • 7+ years of experience in pharmaceutical development; preferred industry experience varies by degree: 4+ years for Ph.D., 5+ years for M.S., 7+ years for B.S. • Experience with formulation development and drug product development, preferably for small molecule drugs • Deep understanding of formulation techniques and considerations for sterile, parenteral dosage forms • Knowledge of ophthalmic or oral dosage forms beneficial • Experience with drug-device combination products for injectable drug products preferred • Technical expertise in formulation strategies and processes for poorly water-soluble APIs preferred • Experience with physicochemical characterization methods for drug substances and drug products • Experience with preclinical study support and early-stage formulation development • Advanced knowledge of MS Office products • Excellent written and verbal communication skills • Strong interpersonal, organizational, technical, analytical, and decision-making skills • Ability to manage multiple processes and documentation requirements • Ability to work independently or in a team • Ability to adapt to changing business and site needs

🏖️ Benefits

• Annual performance incentive bonus • New hire equity package • Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays

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